[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amgen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":625},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,52,0,25,[9,43,66,92,116,139,160,184,210,234,261,285,309,331,356,384,411,432,459,485,513,537,559,582,601],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100053651",false,"NCT07700238","A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)","A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP).","ROMISTER","Inclusion Criteria:\n\n* Age ≥18 years or adult legal age within country if older than 18 years.\n* Diagnosis of primary ITP according to the 2019 International Consensus (ICR) that is previously untreated and requires treatment.\n\n  * Note: The investigator should ensure that the diagnosis of primary ITP is established by excluding other causes of isolated thrombocytopenia, as outlined in the 2019 ICR, which states that the diagnosis of primary ITP is principally based on the exclusion of other causes of isolated thrombocytopenia.\n  * Note: If emergency treatment is necessary, platelet count performed before emergency can be used for study inclusion.\n  * Note: Emergency ITP treatment with any thrombopoietin receptor agonists (TPO-RAs), or splenectomy is not allowed.\n* Platelet count \\\u003C 30 × 10\\^9\u002FL or Platelet count \\\u003C 50× 10\\^9\u002FL with clinically significant bleeding before any medical intervention.\n\nExclusion Criteria:\n\n* Life-threatening bleeding at randomization.\n* Known sensitivity or intolerance to any of the products to be administered during study (eg, uncontrolled diabetes) or to any Escherichia coli-derived product (eg, filgrastim, pegfilgrastim, certain insulins).\n* Uncontrolled hypertension before randomization.\n* Abnormal hepatic or renal function at screening.\n* History of total splenectomy.\n* Use of concurrent anticoagulation therapy and\u002For antiplatelet therapy.\n* Need for nonsteroidal anti-inflammatory drugs (NSAIDs) use and use of NSAIDs within 7 days before randomization.\n* Venous or arterial thrombotic event within 3 or 6 months, respectively, before randomization.\n* Other protocol-defined Inclusion\u002FExclusion may apply.","ALL","18 Years","100 Years",{"count":21,"type":22},126,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).",[28],"Primary Immune Thrombocytopenia",[30],"Adult ITP","NOT_YET_RECRUITING","2026-07-07",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":22},"2026-07-20",{"date":39,"type":22},"2029-09-14",{"name":41,"class":42},"Amgen","INDUSTRY",{"id":44,"slug":4,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100642692","NCT07575399","Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)","A Phase 3, Open-label Trial to Evaluate the Efficacy, Safety and Tolerability of Switching From the Glucagon-like Peptide-1 Receptor Agonists to Maridebart Cafraglutide in Adult Participants With Obesity or Overweight","Inclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 25 at screening.\n* Weight loss of ≥ 10% on weekly GLP-1 RA.\n* Stable body weight.\n* Stable dose of GLP-1RA.\n* Stable gastrointestinal (GI) tolerability.\n* Contraception for females.\n* Willingness to follow trial procedures for the duration of the trial.\n\nExclusion Criteria:\n\n* Obesity induced by other endocrine disorders (ex: Cushing's syndrome).\n* Previous or planned surgical, endoscopic or device-based treatment for obesity.\n* History of malignancy.\n* Type 1\u002FType 2 diabetes mellitus (DM).\n* Family or personal history of medullary thyroid cancer.\n* Previous participation in a Maridebart Cafraglutide trial.","99 Years",{"count":51,"type":22},300,[25],"Efficacy, safety and tolerability of switching from GLP-1RA to maridebart cafraglutide in adults with obesity or overweight.",[55],"Obesity or Overweight","RECRUITING","2026-07-01",{"date":59,"type":35},"2026-07-02",{"date":61,"type":35},"2026-05-11",{"date":63,"type":22},"2028-02-28",{"name":41,"class":42},43,{"id":67,"slug":4,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":72,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100630887","NCT07493512","Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer","A Phase 1b, Open-label Study of Xaluritamig (AMG 509) in Adults With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy imaging obtained within 28 days prior to enrollment.\n* Evidence of progressive disease, defined as 1 or more PCWG3 criteria:\n\n  * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL.\n  * Soft tissue progression defined as an increase ≥ 20% and an absolute increase of ≥ 5 mm in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions.\n  * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scintigraphy (as per the 2+2 PCWG3 criteria).\n* Prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n* Prior progression on at least one androgen receptor pathway inhibitor (androgen receptor pathway inhibitor \\[ARPI\\], enzalutamide, abiraterone, apalutamide, darolutamide).\n* Prior treatment with only one taxane therapy in the mCRPC setting. Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.\n\nExclusion Criteria:\n\n* History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.\n* History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.\n* History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free for \\>3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer.\n* Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.\n* Known positive test for human immunodeficiency virus.\n* Presence or history of viral hepatitis infection.\n* Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of trial treatment with the following exceptions:\n\n  * Androgen-deprivation therapy with luteinizing hormone-releasing hormone\u002Fgonadotropin-releasing hormone (LHRH\u002FGnRH) analogue (agonist\u002Fantagonist) is allowed.\n  * ARPIs (enzalutamide, abiraterone, apalutamide, darolutamide) require a minimum washout of 2 weeks prior to the first dose of xaluritamig.\n  * Prior prostate-specific membrane antigen (PSMA) radionuclide therapy cannot be given within 3 months prior to first dose of xaluritamig unless participant received \\\u003C2 cycles of therapy, in which case participant cannot have received PSMA radionuclide therapy within 35 days prior to first dose.\n* Any prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Any prior cluster of differentiation 3 (CD3)-directed therapy.\n* Requirement for chronic systemic corticosteroid therapy (prednisone dose \\>10 mg\u002Fday or equivalent) or any other immunosuppressive therapies (including anti TNFα therapies).\n* Participation on any other xaluritamig trial, regardless of whether xaluritamig was administered.","MALE",{"count":74,"type":22},40,[76],"PHASE1","The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).",[79],"Metastatic Castration-resistant Prostate Cancer (mCRPC)",[81,82,83,84],"Xaluritamig","AMG 509","mCRPC","Prostate Cancer",{"date":59,"type":35},{"date":87,"type":35},"2026-04-28",{"date":89,"type":22},"2030-07-30",{"name":41,"class":42},5,{"id":93,"slug":4,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100623983","NCT07403721","AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H\u002FdMMR Solid Tumors","A Phase 1\u002F1b Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 436 as Monotherapy and in Combination With Other Therapies in Participants With Microsatellite Instability-high (MSI-H)\u002FMismatch Repair Deficient (dMMR) Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).\n* Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing.\n* Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing.\n* Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).\n* Eastern Cooperative Oncology Group performance (ECOG) 0-1.\n* Adequate organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Participants with primary central nervous system (CNS) tumors.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Major surgery within 28 days of trial day 1.\n* Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 21 days (in this case, enrollment may be allowed with washout from prior therapy of \\\u003C 21 days.\n* Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose).\n* Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).",{"count":99,"type":22},464,[76],"The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and\u002For the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H\u002FdMMR solid tumors.",[103],"Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)",[105,106,107,108],"AMG 436","MSI-H","dMMR","Solid Tumors",{"date":59,"type":35},{"date":111,"type":35},"2026-04-08",{"date":113,"type":22},"2028-06-28",{"name":41,"class":42},20,{"id":117,"slug":4,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100622813","NCT07388498","A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout","A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout","Inclusion Criteria\n\n* Participant has provided informed consent before initiation of any trial-specific activities\u002Fprocedures.\n* Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.\n* Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.\n* Participants with uncontrolled gout, as meeting the protocol defined criteria.\n\nExclusion Criteria\n\n* Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit).\n* Liver transaminase levels (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\]) \\> 1.25 x upper limit of normal (ULN) or albumin \\\u003C the lower limit of normal (LLN) at the screening visit.\n* Uncontrolled diabetes mellitus and\u002For hemoglobin A1c (HbA1c) \\> 8%.\n* Known intolerance to MTX.\n* Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug.\n* A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and\u002For non-steroidal anti-inflammatory drug and\u002For low-dose prednisone ≤ 10 mg\u002Fday or equivalent dose of other corticosteroid).\n* Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations \\\u003C 40 mL\u002Fmin\u002F1.73 m\\^2 or currently on dialysis.",{"count":123,"type":22},270,[25],"The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \\\u003C 6 mg\u002FdL for at least 80% of the time during Month 6.",[127],"Uncontrolled Gout",[127,129,130,131],"Pegloticase","KRYSTEXXA","Kadence",{"date":59,"type":35},{"date":134,"type":35},"2026-02-09",{"date":136,"type":22},"2028-06-18",{"name":41,"class":42},55,{"id":140,"slug":4,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":72,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100603775","NCT07140900","Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer","A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer","Inclusion Criteria:\n\n* Participants must have histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* Participants must have at the time of diagnosis:\n\n  * De novo (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist\u002Fantagonist or orchiectomy) with or without ARPI (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted.\n* Participants must have at the time of diagnosis:\n\n  * High-volume metastatic disease defined as presence of visceral metastasis or metastases, and\u002For ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis.\n* Documented metastatic disease either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast enhanced abdominal\u002Fpelvic\u002Fchest computed tomography (CT) or magnetic resonance imaging (MRI) scan.\n* No documented PSA progression following the initial PSA nadir after starting ADT.\n\nExclusion Criteria:\n\n* Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible.\n* Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology Criteria for Adverse events (CTCAE) version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.\n* Autoimmune disease requiring systemic immunosuppression within the past 2 years.\n* Participant with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active or systemic infection within 7 days prior to the first dose of study treatment.\n* Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or ketoconazole for prostate cancer, or any prior systemic biologic therapy, including immunotherapy for prostate cancer.\n* Prior enzalutamide or apalutamide within 15 days prior to enrolment.\n* Requirement for chronic systemic corticosteroid therapy (prednisone dose greater than 10 mg per day or local equivalent) or any other immunosuppressive therapies (including anti TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.\n* Prior radiotherapy to all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.",{"count":146,"type":22},60,[76],"The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.",[150],"Metastatic Hormone-sensitive Prostate Cancer (mHSPC)",[152,81],"Prostate cancer",{"date":59,"type":35},{"date":155,"type":35},"2025-10-07",{"date":157,"type":22},"2030-03-30",{"name":41,"class":42},16,{"id":161,"slug":4,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":166,"sex":17,"minAge":18,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":74},"100546905","NCT06401044","A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease","A Phase 1\u002F2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects With Moderate-to-Severe Active Thyroid Eye Disease","Inclusion criteria for Part A\u002FPhase 1 only:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Male or female aged 18 to 55 years (Part A).\n* Female participants must be of non-childbearing potential.\n* Body mass index (BMI) between 18 and 30 kg\u002Fm\\^2, inclusive, at screening.\n* The participant has adequate venous access and can receive intravenous (IV) therapy.\n* The participant is considered by the investigator or designee to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.\n* Healthy Japanese participants in cohort 4 only. Japanese participants must meet all the following as confirmed by interview: Descendants of 4 ethnic Japanese grandparents who were born in Japan; Both parents are ethnic Japanese who were born in Japan; Hold a Japanese passport or identity papers; Have lived outside Japan for less than 10 years at the time of screening and lifestyle including diet has not changed significantly since leaving Japan.\n\nInclusion criteria for Part B\u002FPhase 2 only:\n\n* Male or female aged 18 to 65 years.\n* Moderate-to-severe active TED.\n* The participant had onset of active TED within 15 months prior to baseline.\n* Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS)≥3 for the most severely affected eye at screening and baseline.\n* Proptosis ≥18mm in the study eye at baseline.\n* Participants with baseline subjective binocular diplopia score \\>0.\n* Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery\u002Firradiation during the trial.\n\nExclusion criteria for Part A and Part B:\n\n* Malignant condition in the past 12 months or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study.\n* Active liver or kidney disfunction at screening.\n* Positive test for hepatitis B\u002FC or Human immunodeficiency virus (HIV) serology at screening.\n* Glycated hemoglobin (HbA1c) \\> 6.5% and\u002For fasting glucose levels\\> 126 mg\u002FdL (\\> 7 mmol\u002FL) at screening.\n* Use of any steroid (IV, oral, steroid eye drops) within 3 weeks prior to the first dose. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat injection related reactions or short course of steroid for asthma control.\n* Known hypersensitivity to teprotumumab or any other monoclonal antibody products.\n* History of substance abuse within 12 months before screening.\n* Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing.\n\nExclusion criteria for PartA\u002FPhase 1 only\n\n• Blood pressure or ECG abnormalities at screening.\n\nExclusion criteria for Part B\u002FPhase 2 only:\n\n* Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug.\n* Use of teprotumumab or any other IGF-1R inhibitor.\n* Prior orbital irradiation or decompression in the study eye.\n* History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease).\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply.",true,"65 Years",{"count":169,"type":22},88,[76,171],"PHASE2","The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.",[174],"Thyroid Eye Disease",[176,174,177],"AMG 732","TED",{"date":59,"type":35},{"date":180,"type":35},"2024-05-30",{"date":182,"type":22},"2027-08-13",{"name":41,"class":42},{"id":185,"slug":4,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100535501","NCT06252649","Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","CodeBreaK 301","Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan",{"count":192,"type":22},450,[25],"The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.",[196],"Metastatic Colorectal Cancer",[198,199,200,201,202],"Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology",{"date":59,"type":35},{"date":205,"type":35},"2024-07-17",{"date":207,"type":22},"2032-04-25",{"name":41,"class":42},292,{"id":211,"slug":4,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":166,"sex":17,"minAge":18,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":91},"100634864","NCT07545226","Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose.","An Open-Label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products","Inclusion Criteria:\n\n1. Male or female, of any race, between 18 and 60 years of age, inclusive.\n\n   a. Females must not be pregnant or lactating.\n2. Body mass index (BMI) between 18.0 and 32.0 kg\u002Fm\\^2 inclusive.\n3. LDL-C level ≥ 70 mg\u002FdL (1.8 mmol\u002FL) and ≤ 190 mg\u002FdL (4.9 mmol\u002FL) at screening.\n\nExclusion Criteria:\n\n1. History or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator (or designee) would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.\n2. History or current signs or symptoms of cardiovascular disease.\n3. History or evidence of clinically significant arrhythmia.\n4. History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs.\n5. Uncontrolled hyperthyroidism or hypothyroidism.\n6. Current use or prior use of over-the-counter or other prescription medications, herbal medicines, vitamins, and supplements within 30 days or 5 half-lives prior to check-in.\n7. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in.\n8. Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9 inhibitor.","60 Years",{"count":218,"type":22},400,[76],"The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants.",[222],"Healthy Participants",[224,225,226],"Evolocumab","AMG 145","Pharmacokinetics","2026-06-30",{"date":57,"type":35},{"date":230,"type":35},"2026-04-21",{"date":232,"type":22},"2026-09-08",{"name":41,"class":42},{"id":235,"slug":4,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":240,"minAge":241,"maxAge":167,"enrollmentInfo":242,"targetDuration":4,"studyType":23,"phases":244,"briefSummary":245,"conditions":246,"keywords":249,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100633209","NCT07523711","Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity","A Phase 1, Open-label Study to Assess the Effect of Maridebart Cafraglutide (AMG 133) on the Pharmacokinetics of Oral Contraceptives in Postmenopausal Female Participants Living With Overweight or Obesity","Inclusion Criteria\n\n1. Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria.\n2. Body mass index must be ≥ 25.0 and ≤ 38.0 kg\u002Fm\\^2.\n3. Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening.\n4. Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening.\n5. Other inclusion criteria may apply.\n\nExclusion Criteria\n\n1. History or evidence of any clinically significant medical condition, abnormal physical exam, ECG, vital sign, or laboratory finding that could increase risk or interfere with study participation.\n2. History of diabetes, active diabetes, or hemoglobin A1c 6.5% or higher.\n3. Endocrine disorders that can cause obesity, such as Cushing's syndrome.\n4. History of acute or chronic pancreatitis within 1 year before check-in, pancreatic enzyme elevations greater than 2 times the upper limit of normal, or fasting triglycerides greater than 300 mg\u002FdL.\n5. Bleeding or clotting disorders, abnormal coagulation tests, or a history of venous or arterial blood clots or conditions that increase clot risk.\n6. LDL cholesterol greater than 159 mg\u002FdL.\n7. Migraine with aura, normal pressure hydrocephalus, or ischemic optic neuropathy.\n8. Malignancy within the past 5 years, except nonmelanoma skin cancer.\n9. Unexplained postmenopausal vaginal bleeding, untreated endometrial disease, or other gynecologic conditions that could worsen with estrogen\u002Fprogestin therapy.\n10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or uncontrolled thyroid disease.\n11. Gastroparesis, inability to swallow oral medication, clinically important gastrointestinal disease, malabsorption, uncontrolled inflammatory bowel disease, certain gastrointestinal surgeries, or recent bariatric surgery.\n12. Clinically significant cardiovascular disease, clinically significant arrhythmia, long QT syndrome, QTcF greater than 470 msec, second- or third-degree atrioventricular block, or clinically important abnormal pulse rate or systolic blood pressure \\> 150 mmHg or \\\u003C 90 mmHg, diastolic blood pressure \\> 95 mmHg or \\\u003C 50 mmHg.\n13. Allergy, hypersensitivity, intolerance, or contraindication to maridebart cafraglutide, ethinyl estradiol, or orgestimate.\n14. Reduced kidney function with estimated glomerular filtration rate 60 mL\u002Fmin\u002F1.73 m\\^2 or lower, ALT or AST greater than 2 times the upper limit of normal, or a history of acute or chronic liver disease, hepatic adenoma, or hepatic carcinoma.\n15. Hemoglobin or hematocrit below the lower limit of normal.\n16. Positive HIV test, or positive hepatitis B surface antigen or hepatitis C antibody at screening.\n17. Lifetime history of suicide attempt, non-suicidal self-injury within 5 years, or unstable major depressive disorder or other severe psychiatric disorder within 2 years.\n18. Positive pregnancy test at screening or check-in.\n19. Recent use of medications that could affect study participation, including most prescription or over-the-counter medications, systemic hormone replacement therapy, certain contraceptive hormones, CYP enzyme inducers or inhibitors, GLP-1 receptor or GIP receptor agents, and nonpermitted herbal products, vitamins, or supplements.\n20. Recent participation in another investigational study, prior participation in this study, or prior exposure to maridebart cafraglutide.\n21. Tobacco or nicotine use within 3 months before check-in, positive cotinine test, history of alcoholism or drug abuse, positive alcohol or illicit drug testing, recent illicit drug use, or unwillingness to avoid illicit drugs or cannabinoids during the study.\n22. Recent blood, plasma, or platelet donation.\n23. Other exclusion criteria may apply.","FEMALE","45 Years",{"count":243,"type":22},45,[76],"The primary objective of the trial is to evaluate the effect of maridebart cafraglutide on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in postmenopausal female participants living with overweight or obesity.",[247,248],"Overweight","Obesity",[250,251,252,253],"Maridebart Cafraglutide","AMG 133","Norgestimate","Ethinyl Estradiol",{"date":57,"type":35},{"date":256,"type":35},"2026-04-09",{"date":258,"type":22},"2026-11-18",{"name":41,"class":42},3,{"id":262,"slug":4,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100595823","NCT07037459","Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)","MARITIME-HF","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent.\n* BMI ≥ 30.0 kg\u002Fm\\^2 at randomization.\n* HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.\n* Managed with HF standard of care therapies.\n* Left ventricular ejection fraction (LVEF) of \\> 40% within 12 months before randomization.\n\nExclusion Criteria:\n\n* History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.\n* HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy\u002Fdysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.\n* Hospitalized with acute decompensated HF at the time of or during the screening period.\n* Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.\n* For participants with a prior diagnosis of T2DM (including those diagnosed during screening):\n\n  1. HbA1c \\> 10.0% (86 mmol\u002Fmol) at screening\n  2. Uncontrolled diabetes requiring immediate therapy\n  3. History of diabetic ketoacidosis or hyperosmolar state\u002Fcoma within 12 months before randomization\n  4. One or more episodes of severe hypoglycemia within 6 months before randomization and\u002For history of hypoglycemia unawareness\n  5. History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic retinopathy and\u002For macular edema.\n* SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP \\> 160 mmHg during the screening period (including day 1 prior to randomization).\n* History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.\n* Any personal lifetime history of, or family history(first-degree relative\\[s\\]) of medullary thyroid carcinoma or MEN-2.\n* eGFR \\\u003C 20 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.\n* Calcitonin ≥ 50 ng\u002FL (pg\u002FmL) at screening.\n* Acute or chronic hepatitis.\n* Any of the following psychiatric history:\n\n  1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period\n  2. Lifetime history of suicide attempt\n  3. History of non-suicidal self-injury within 5 years prior to screening or during the screening period.\n* History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.\n* Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or planned use during the conduct of the trial.",{"count":269,"type":22},5056,[25],"This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.",[273,274,248],"Heart Failure With Preserved Ejection Fraction","Heart Failure With Mildly Reduced Ejection Fraction",[276,248,250,251,277],"Heart Failure","MariTide",{"date":59,"type":35},{"date":280,"type":35},"2025-06-25",{"date":282,"type":22},"2030-09-29",{"name":41,"class":42},628,{"id":286,"slug":4,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100562064","NCT06598306","Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)","A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)","DeLLphi-308","Inclusion Criteria:\n\n* Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.\n* Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.\n\nNote: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).\n* Participants must be able to have SC injections administered in the abdomen.\n* Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.\n\nExclusion Criteria:\n\n* Participants that have received prior DLL3 targeted therapy.\n* Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.\n* Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).\n* Participants with leptomeningeal disease.\n* Participants with baseline oxygen requirement.",{"count":293,"type":22},220,[76],"The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.",[297],"Extensive Stage Small Cell Lung Cancer",[299],"Small Cell Lung Cancer","2026-06-25",{"date":302,"type":35},"2026-06-26",{"date":304,"type":35},"2024-10-07",{"date":306,"type":22},"2030-04-24",{"name":41,"class":42},31,{"id":310,"slug":4,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},"100626651","NCT07438405","An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease","An Open-label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-sponsored AMG 732 Studies and Are Primary Proptosis Non-responders or Who Relapsed During the Safety Follow-up","HAZEL 401","Inclusion Criteria\n\n1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. Age ≥ 18 years at the time of signing informed consent for parent trial.\n3. Moderate-to-severe TED at the time of enrollment in parent trial and does not require immediate surgical ophthalmological intervention and is not planning corrective surgery\u002Firradiation during the rollover trial.\n4. Any worsening in thyroid status should be corrected to maintain euthyroid status for the entire rollover trial.\n5. Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.\n6. Participants with TED who completed Amgen-sponsored clinical trial of AMG 732.\n\nExclusion Criteria\n\n1. Prior orbital irradiation or decompression in the study eye.\n2. Prior adult strabismus surgery.\n3. Use of any steroid (intravenous, oral, or injected) and steroid eye drops or other non-steroid immunosuppressive agent, monoclonal antibody except the trial drug in parent trial within a protocol-specified number of months prior to the first injection of study drug.\n4. Glycated hemoglobin (HbA1c) \\> 6.5% and\u002For fasting glucose levels\\> 126 mg\u002FdL (\\> 7 mmol\u002FL) at screening.\n5. Malignant condition in the past 5 years or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study.\n6. Active liver or kidney disfunction at screening.\n7. Positive test for hepatitis B\u002FC or Human immunodeficiency virus (HIV) serology at screening.\n8. Known hypersensitivity to teprotumumab, AMG 732 or any other monoclonal antibody products.\n9. Participants have had an adverse event that is considered related to AMG 732 which required study drug interruption\u002Fdiscontinuation in the parent study\n10. Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing.\n11. Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug.\n12. History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease).\n13. Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":317,"type":22},30,[171],"The main objective of this trial is to assess the efficacy of AMG 732 in participants with thyroid eye disease (TED) who are defined as primary nonresponders or relapsed during the safety follow-up in the parent trial (NCT06401044).",[174],[322,176],"Thyroid eye disease","2026-06-24",{"date":302,"type":35},{"date":326,"type":35},"2026-05-07",{"date":328,"type":22},"2028-07-14",{"name":41,"class":42},6,{"id":332,"slug":4,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":72,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"100609368","NCT07213674","A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n* Participant must have histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.\n* Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:\n\n  * Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng\u002FmL.\n  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.\n  * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).\n* Participants must have had prior orchiectomy and\u002For ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL).\n* Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.\n* Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\nDisease Related:\n\n* Participants with a history of central nervous system (CNS) metastases.\n* Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.\n\nPrior\u002FConcomitant Therapy:\n\n* Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Prior disease progression on or intolerance to abiraterone.\n* Prior treatment with any chemotherapy regimen in the mCRPC setting and\u002For \\> 6 cycles of docetaxel treatment in the mHSPC setting.\n* Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:\n\n  * Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.\n  * Androgen suppression therapy (eg, luteinizing hormone-releasing hormone\u002Fgonadotrophin releasing hormone \\[LHRH\u002FGnRH\\] analogue \\[agonist\u002Fantagonist\\]) is permitted.\n* Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.\n* Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.\n* Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.\n* Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.\n* Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.\n* Prior CD3-directed therapy.",{"count":338,"type":22},750,[25],"The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).",[342],"Metastatic Castration-resistant Prostate Cancer",[84,344,81,345,346,347,348],"Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer","Abiraterone","Abiraterone Acetate","Docetaxel","Cabazitaxel",{"date":300,"type":35},{"date":351,"type":35},"2025-11-28",{"date":353,"type":22},"2032-08-30",{"name":41,"class":42},136,{"id":357,"slug":4,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":362,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100603399","NCT07136012","OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events","A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants With Elevated Lipoprotein(a)","Inclusion Criteria:\n\n* Age ≥50 years\n* Lp(a)≥ 200 nmol\u002FL during screening\n* Multiple atherosclerotic cardiovascular disease risk factors, and\u002For evidence of atherosclerosis\n\nExclusion Criteria:\n\n* Prior acute atherothrombotic event (myocardial infarction, stroke, transient ischemic attack, acute limb ischemia)\n* Prior or planned arterial revascularization\n* History of major bleeding disorder","50 Years","105 Years",{"count":365,"type":22},11000,[25],"The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp\\[a\\]).",[369],"Cardiovascular Disease",[371,372,373,374,375,376],"Olpasiran","AMG 890","Coronary heart disease","CHD","Myocardial infarction","Coronary revascularization",{"date":300,"type":35},{"date":379,"type":35},"2025-08-22",{"date":381,"type":22},"2031-10-20",{"name":41,"class":42},248,{"id":385,"slug":4,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100600178","NCT07094113","AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors","A Phase 1\u002F1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years (or \\> legal age within the country if it is older than 18 years).\n2. Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT amplification assay.\n3. Participants must have no standard of care treatment options or have actively refused such therapy.\n4. Able to swallow and retain per oral administered study treatment.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n6. Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator.\n7. Adequate organ function.\n8. Archival (formalin-fixed, paraffin-embedded \\[FFPE\\]) tumor tissue or block collected within 5 years before screening must be available. Participants without archived tumor tissue may undergo tumor biopsy before AMG 410 dosing (Day1).\n\nExclusion Criteria:\n\n1. Untreated symptomatic central nervous system or leptomeningeal metastases.\n2. Uncontrolled pleural effusion and\u002For ascites.\n3. History of other malignancy within the past 5 years.\n4. Active systemic infection or symptoms that indicate an acute and\u002For uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment.\n5. History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis).\n6. Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment.\n7. History of solid organ transplant.\n8. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment.\n9. Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n10. Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1.\n11. Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment.\n12. Major surgery within 28 days of first dose of study treatment.\n13. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.",{"count":391,"type":22},434,[76],"The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when administered alone or in combination with other agents in participants with advanced or metastatic solid tumors harboring KRAS alterations.\n\nThis is a dose-escalation study in which participants will be assigned to multiple dose levels (DLs) of AMG 410, either as monotherapy or in combination with other agents, followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose (MTD)-the highest dose with acceptable safety and manageable side effects-or the Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered advanced or metastatic solid tumors.",[395],"KRAS Altered Advanced or Metastatic Solid Tumors",[397,398,399,400,401,402,403],"Non-small cell lung cancer","NSCLC","Colorectal cancer","CRC","Pancreatic ductal adenocarcinoma","PDAC","AMG 410",{"date":300,"type":35},{"date":406,"type":35},"2025-07-31",{"date":408,"type":22},"2031-04-20",{"name":41,"class":42},36,{"id":412,"slug":4,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":418,"targetDuration":4,"studyType":23,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100593337","NCT07005128","A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)","A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)","DeLLphi-312","Inclusion Criteria:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.\n* Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \\[T any, N any, M1 a\u002Fb\u002Fc\\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n* Measurable disease as defined per RECIST 1.1.\n* Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.\n* Minimum life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* Participants can have no history of other malignancy in the last 2 years.\n* Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.\n* They will have no history of severe or life-threatening events to immune-mediated therapy.\n* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.\n* They will have no active autoimmune or inflammatory disorders.\n* Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B\u002FC) infection.\n* Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.\n* History of solid organ transplant.\n* They will not have had a myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 6 months prior to first dose of study treatment.",{"count":419,"type":22},330,[25],"The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).",[423,424],"Small-cell Lung Cancer","Extensive Stage Small-cell Lung Cancer",{"date":300,"type":35},{"date":427,"type":35},"2025-08-18",{"date":429,"type":22},"2029-07-15",{"name":41,"class":42},164,{"id":433,"slug":4,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":441,"phases":4,"briefSummary":442,"conditions":443,"keywords":446,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":458},"100538810","NCT06295679","A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease","A Real-world, Prospective, Observational Study Assessing the Effectiveness of Repatha® Used in Combination With Standard of Care Compared With Standard of Care Alone on Major Cardiovascular Events in Chinese Patients With Established Atherosclerotic Cardiovascular Disease","Inclusion Criteria:\n\n* Adult participants ≥ 18 years of age.\n* Participants or participant's legally authorized representative has provided informed consent to participate in this study.\n* Participants who meet one of the following:\n* Prescribed Repatha® in addition to an existing SOC treatment according to local guidelines and approved label.\n\nOR\n\n* Already received SOC treatment prior to enrollment.\n* Participants with ANY of the following.\n* Diagnosis of MI OR stroke within 2 years before enrollment.\n* 2 MIs OR ≥ 2 strokes OR (≥ 1 MI AND ≥ 1 stroke) any time before enrollment.\n* Diagnosis of (MI OR stroke) AND diabetes.\n* Diagnosis of (MI OR stroke) AND documented multivessel disease (defined as \\> 50% stenosis of ≥ 2 major coronary arteries on coronary angiography or coronary artery contrast enhanced computed tomography).\n* Diagnosis of symptomatic peripheral arterial disease.\n* Most recent fasting LDL-C ≥ 70 mg\u002FdL (≥ 1.8 mmol\u002FL) or nonhigh-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL) within 6 months prior to enrollment.\n* Most recent fasting triglycerides ≤ 400 mg\u002FdL (≤ 4.5 mmol\u002FL) within 6 months prior to enrollment.\n\nExclusion Criteria:\n\n* Stroke within past 1 month.\n* Known hemorrhagic stroke at any time.\n* Stroke due to thromboembolic event.\n* Any prior use of Repatha® or other proprotein convertase subtilisin\u002Fkexin type 9 inhibition treatments within past 6 months prior to enrollment.\n* Participants currently enrolled in another study involving any investigational procedure, device or drug.\n* Participants prescribed Repatha® with a history of severe hypersensitivity or allergy to any subsidiary.","150 Years",{"count":440,"type":22},7000,"OBSERVATIONAL","The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice.",[444,445],"Major Cardiovascular Event","Established Atherosclerotic Cardiovascular Disease",[447,375,448,449,376,450,451],"Cardiovascular death","Stroke","Unstable angina","Atherosclerotic Cardiovascular Disease","Repatha",{"date":300,"type":35},{"date":454,"type":35},"2022-12-19",{"date":456,"type":22},"2028-12-19",{"name":41,"class":42},90,{"id":460,"slug":4,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":166,"sex":17,"minAge":18,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":484},"100640678","NCT07590193","A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus","A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus","Inclusion Criteria for Part A and B\n\n* Participant must be 18-65 years of age\n* Participant must be overtly healthy\n\nInclusion Criteria for Part C\n\n* Participant must be 40-75 years of age\n* Confirmed diagnoses of T2DM\n\nExclusion Criteria for Part A and B\n\n* History of hypotension, syncope, or orthostatic intolerance\n* Systolic blood pressure \\>140 millimeters of mercury (mmHg) or diastolic blood pressure \\>90 mmHg\n\nExclusion Criteria for Part C\n\n* Hemoglobin A1c (HbA1c) \\>10% within the last 3 months\n* History of hypotension, syncope, or orthostatic intolerance\n* Systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg","75 Years",{"count":467,"type":22},162,[76],"The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).",[471],"Diabetes Mellitus, Type 2",[473,474,475],"AMG 127","healthy participants","type 2 diabetes mellitus","2026-06-19",{"date":478,"type":35},"2026-06-23",{"date":480,"type":35},"2026-06-11",{"date":482,"type":22},"2027-10-02",{"name":41,"class":42},1,{"id":486,"slug":4,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":17,"minAge":362,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":498,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":115},"100642316","NCT07614776","A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration","A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Men or women ≥ 50 years old, capable of giving signed informed consent\n* Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)\n* Total area of CNV (including both classic and occult components) \\> 50% of the total lesion area in the SE\n* The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE\n* Presence of intra and\u002For subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:\n\n* Total lesion size \\> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye\n* Scar, fibrosis, or atrophy involving the central subfield in the study eye\n* Scar or fibrosis involving \\> 50% of the total lesion in the study eye\n* Presence of retinal pigment epithelium tears or rips involving the macula in the study eye\n* History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study\n* Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study\n* Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with anti-glaucoma medication) in the study eye\n* History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye\n* Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization\n* Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening\n* Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF\u002Fanti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins\n* History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation\n* Other protocol-specified exclusion criteria",{"count":492,"type":22},304,[25],"The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)",[496,497],"Neovascular Age-related Macular Degeneration","nAMD",[499,500,501,502,503,504],"ABP 938","Aflibercept","neovascular age-related macular degeneration","Intravitreal","Randomized Controlled Trial","Double-masked","2026-06-18",{"date":507,"type":35},"2026-06-22",{"date":509,"type":35},"2026-05-27",{"date":511,"type":22},"2028-01-12",{"name":41,"class":42},{"id":514,"slug":4,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":17,"minAge":519,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":527,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":536},"100621089","NCT07366086","Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta","Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta","Inclusion Criteria:\n\n\\- Participant has provided informed consent\u002Fassent prior to initiation of any trial specific activities\u002Fprocedures.\n\nOR Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and\u002For guidelines prior to any trial-specific activities\u002Fprocedures being initiated.\n\n\\- Participant was randomized to the romosozumab arm and completed Trial 20200105 through the Month 15 Visit, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.\n\nExclusion Criteria:\n\n* Currently receiving treatment in another investigational device or drug trial, or less than 2 years since ending treatment on another investigational device or drug trial(ies) with the exception of trial 20200105. Other investigational procedures while participating in this trial are excluded.\n* Participant likely to not be available to complete all protocol-required trial visits or procedures, and\u002For to comply with all required trial procedures to the best of the participant and investigator's knowledge.","5 Years","19 Years",{"count":522,"type":22},71,[25],"The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.",[526],"Osteogenesis Imperfecta",[528,529],"Romosozumab","EVENITY",{"date":507,"type":35},{"date":532,"type":35},"2026-03-18",{"date":534,"type":22},"2028-04-19",{"name":41,"class":42},4,{"id":538,"slug":4,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":166,"sex":17,"minAge":18,"maxAge":167,"enrollmentInfo":543,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":558},"100561077","NCT06585462","Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity","Inclusion Criteria:\n\n* Participants in the study will be males and females 18 to 65 years of age at the time of signing the informed consent with a body mass index (BMI) of 30.0 kg\u002Fm\\^2 to 40.0 kg\u002Fm\\^2 for Part A and BMI of 27.0 kg\u002Fm\\^2 to 40.0 kg\u002Fm\\^2 for Part B.\n* Females enrolled must be of non-childbearing potential.\n\nExclusion Criteria:\n\n* History and\u002For clinical evidence of diabetes mellitus, including hemoglobin A1c ≥ 6.5% and\u002For a fasting glucose of ≥ 126 mg\u002FdL (7 mmol\u002FL) at screening.\n* Triglycerides ≥ 5.65 mmol\u002FL (i.e., 500 mg\u002FdL) at screening.",{"count":544,"type":22},80,[76],"The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.",[548],"Cardiometabolic Disease",[550,551],"AMG 513","Cardiometabolic disease",{"date":507,"type":35},{"date":554,"type":35},"2024-09-09",{"date":556,"type":22},"2026-10-01",{"name":41,"class":42},10,{"id":560,"slug":4,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":581},"100626870","NCT07441252","A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight","Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Body Mass index (BMI) ≥ 27 kg\u002Fm\\^2 to ≤ 40 kg\u002Fm\\^2 at screening.\n* For participants with type 2 diabetes mellitus (T2DM) at screening:\n* HbA1c ≤ 9.5% (80 mmol\u002Fmol) at screening.\n* Treated with diet and exercise alone and\u002For a stable treatment with metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or combination.\n* Liver Controlled Attenuation Parameter (CAPTM) ≥ 300 dB\u002Fmeter via FibroScan® assessment.\n* Liver fat content ≥ 10% by MRI as determined by the central imaging vendor at screening.\n* MRI assessment should only be performed after all other eligibility has been confirmed whenever possible.\n* History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.\n\nExclusion Criteria:\n\n* Recent or planned surgical\u002Fdevice-based obesity treatment (\\\u003C1 year).\n* History of malignancy within the past 5 years (exceptions apply).\n* Type 1 diabetes or non-type 2 diabetes mellitus (T2DM); unstable\u002Fsevere hypoglycemia.\n* Advanced diabetic retinopathy or macular edema.\n* History of pancreatitis (acute \\\u003C180 days or chronic).\n* History of medullary thyroid carcinoma (MTC) or MEN-2\n* Major cardiovascular event within 60 days (e.g., myocardial infarction \\[MI\\], stroke, coronary artery bypass graft \\[CABG\\]).\n* New York Heart Association (NYHA) Class IV heart failure.\n* Unstable psychiatric disorders within 2 years.\n* Significant liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD) (e.g., hepatitis, cirrhosis, hepatic decompensation).\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2 or on dialysis.\n* Patient Health Questionnaire-9 (PHQ-9) ≥ 15, or suicidal ideation\u002Fbehavior (Columbia-Suicide Severity Rating Scale \\[C-SSRS\\]).\n* Inability to undergo MRI scan (e.g., due to metal implant, claustrophobia, or body size limitations).",{"count":566,"type":22},180,[171],"The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body weight in participants living with obesity or overweight and elevated liver fat content, when administered in conjunction with reduced-calorie diet and increased physical activity.",[570],"Overweight or Obesity and Elevated Liver Fat",[248,247,572,251,573],"Elevated liver fat","Maridebart cafraglutide","2026-06-17",{"date":505,"type":35},{"date":577,"type":35},"2026-03-05",{"date":579,"type":22},"2027-12-22",{"name":41,"class":42},23,{"id":583,"slug":4,"hasResults":11,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":11,"sex":17,"minAge":241,"maxAge":49,"enrollmentInfo":589,"targetDuration":4,"studyType":23,"phases":591,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":599,"locationsCount":600},"100595821","NCT07037433","Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity","MARITIME-CV","Inclusion Criteria\n\n* Age ≥ 45 years at screening.\n* BMI of ≥ 27.0 kg\u002Fm\\^2 at screening.\n* History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:\n\n  * Prior MI (presumed atherothrombotic event due to plaque rupture\u002Ferosion).\n  * Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation).\n  * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \\\u003C 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.\n\nExclusion Criteria\n\n* History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA).\n* New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization.\n* Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification.\n* For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening):\n\n  * HbA1c \\> 10.0% (86 mmol\u002Fmol) at screening.\n  * History of diabetic ketoacidosis or hyperosmolar state\u002Fcoma within 12 months before randomization.\n  * One or more episodes of severe hypoglycemia within 6 months before randomization and\u002For history of hypoglycemia unawareness.\n  * History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and\u002For diabetic macular edema.\n* Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial.\n* History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization.\n* Family (first-degree relative\\[s\\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).\n* Calcitonin ≥ 50 ng\u002FL (pg\u002FmL) at screening.\n* Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \\> 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) \\> 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).\n* History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).\n* Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.",{"count":590,"type":22},12800,[25],"The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.",[450,247,248],[450,247,248,573,251,277],{"date":505,"type":35},{"date":597,"type":35},"2025-07-25",{"date":282,"type":22},{"name":41,"class":42},774,{"id":602,"slug":4,"hasResults":11,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":11,"sex":17,"minAge":607,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":614,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":624},"100540804","NCT06321601","Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to \u003C 18 Years of Age With AAV.","A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children From 6 Years to \u003C 18 Years of Age With Active ANCA-associated Vasculitis (AAV)","Inclusion Criteria:\n\n* Male and female children and adolescents from 6 to \\\u003C 18 years old of age.\n* Clinical diagnosis of Granulomatosis with Polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013).\n* Positive anti-PR3(Anti-Proteinase 3) or anti-MPO(Anti-Myeloperoxidase) antibody documented at Screening or historically. Historical positivity is acceptable (even if Screening is negative) if supported by verifiable lab source documentation obtained during AAV diagnosis or disease course; use the most recent positive result.\n* At least 1 PVAS major item, at least 3 PVAS nonmajor items, or atleast the 2 renal items of proteinuria and hematuria.\n* Estimated glomerular filtration rate (eGFR) of ≥ 15 mL\u002Fminute\u002F1.73 m\\^2 at screening and day 1.\n* Participants must have a bodyweight of ≥ 15 kg at day 1.\n\nExclusion Criteria:\n\n* Any other known multisystem autoimmune disease including and not limited to eosinophilic granulomatosis with polyangiitis (EGPA, previously, Churg-Strauss disease), systemic lupus erythematosus, IgA vasculitis \u002F Henoch-Schönlein, Purpura, rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis.\n* Renal replacement therapy \u002F plasmapheresis: subjects will be excluded who received, require, or initiate CRRT (continuous renal replacement therapy), hemodialysis, any renal dialysis, or plasmapheresis within 14 days prior to Screening or between Screening and Day 1.\n* History of kidney transplantation or is anticipated to require renal transplantation during the study.\n* Alveolar hemorrhage requiring invasive pulmonary ventilation support anticipated to last beyond the screening period of the study.\n* Any medical condition requiring, or expected to require, ongoing treatment with immunosuppressive, therapy (including systemic glucocorticoids) for a non-AAV indication that in the judgment of the investigator, could confound study assessments or interpretation of study results.\n* Female subjects of childbearing potential must have a negative highly sensitive serum pregnancy test at Screening and a negative sensitive urine pregnancy test, on day 1, with results confirmed prior to the first administration of investigational product.\n* Known hypersensitivity or contraindication to avacopan, its excipients, or to any investigational product or required concomitant medication used in this study.\n* Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition, or disease (other than those specified above) that, in the investigator's judgment, would pose an unacceptable risk to subject safety, or interfere with study assessments or completion. The investigator may consult the Amgen medical monitor as needed. The rationale for exclusion and any consultation must be documented in the subject's source record.","6 Years","17 Years",{"count":115,"type":22},[25],"The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.",[613],"Vasculitis",[615,616,617],"Pediatric","Avacopan","Tavneos®",{"date":505,"type":35},{"date":620,"type":35},"2024-10-22",{"date":622,"type":22},"2028-09-26",{"name":41,"class":42},34,""]