[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593648":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":58,"centralContacts":62,"locations":70,"responsibleParty":116,"collaborators":41,"id":118,"slug":41,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":41,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":41,"enrollmentInfo":126,"targetDuration":41,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":73,"whyStopped":41,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"NeuroBiogen Co., Ltd","INDUSTRY",[8,14,20,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"1 stage Control Group_Placebo","PLACEBO_COMPARATOR","Administer orally three tablets once daily for 12 weeks (three tablets of 60mg placebo). This group will match the investigational drug in appearance but contain no active ingredients to maintain blinding.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"1 stage Treatment Group 1_KDS2010 120mg","EXPERIMENTAL","Administer orally three tablets once daily for 12 weeks (two tablets of KDS2010 60mg and one tablet of 60mg placebo). This group will receive the active investigational drug to evaluate its safety and efficacy.",[19,13],"Drug: KDS2010",{"label":21,"type":10,"description":11,"interventionNames":22},"2 stage Control Group_Placebo",[13],{"label":24,"type":16,"description":25,"interventionNames":26},"2 stage Treatment Group 1_KDS2010 180mg","Administer orally three tablets once daily for 12 weeks (three tablets of KDS2010 60mg). This group will receive the active investigational drug to evaluate its safety and efficacy.",[19],{"label":28,"type":10,"description":29,"interventionNames":30},"3 stage Control Group_Placebo","Administer orally four tablets once daily for 12 weeks (four tablets of 60mg placebo). This group will match the investigational drug in appearance but contain no active ingredients to maintain blinding.",[13],{"label":32,"type":16,"description":33,"interventionNames":34},"3 stage Treatment Group 1_KDS2010 240mg","Administer orally four tablets once daily for 12 weeks (four tablets of KDS2010 60mg). This group will receive the active investigational drug to evaluate its safety and efficacy.",[19],[36,42,45,48,52,55],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","KDS2010","KDS2010 will be administered orally once daily, two tablets per day, for 12 weeks. Dosage will be 120 mg depending on the assigned group.",[15],null,{"type":37,"name":38,"description":43,"armGroupLabels":44,"otherNames":41},"KDS2010 will be administered orally once daily, three tablets per day, for 12 weeks. Dosage will be 180 mg depending on the assigned group",[24],{"type":37,"name":38,"description":46,"armGroupLabels":47,"otherNames":41},"KDS2010 will be administered orally once daily, four tablets per day, for 12 weeks. Dosage will be 240mg depending on the assigned group.",[32],{"type":37,"name":49,"description":50,"armGroupLabels":51,"otherNames":41},"Placebo","Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, one tablets per day, for 12 weeks.",[15],{"type":37,"name":49,"description":53,"armGroupLabels":54,"otherNames":41},"Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, three tablets per day, for 12 weeks.",[9,21],{"type":37,"name":49,"description":56,"armGroupLabels":57,"otherNames":41},"Placebo matching the investigational product in appearance but containing no active ingredient, administered orally once daily, four tablets per day, for 12 weeks.",[28],[59],{"name":60,"affiliation":5,"role":61},"Sangwook Kim, Chief Executive Officer","STUDY_DIRECTOR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":41,"email":67},"Jaeheon Kang, Professor","CONTACT","+82)2-6959-9927","jenny.kim@mdnf.co.kr",{"name":69,"role":65,"phone":41,"phoneExt":41,"email":41},"Sujeong Shin, Professor",[71,91,104],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":41,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"The Catholic University of Korea, St. Vincent's Hospital","RECRUITING","Suwon","Gyeonggi-do","16247","South Korea",{"type":79,"coordinates":80},"Point",[81,82],127.00889,37.29111,{"lat":82,"lon":81},[85,87,89],{"name":86,"role":65,"phone":66,"phoneExt":41,"email":67},"Sangwook Song, Professor",{"name":88,"role":65,"phone":41,"phoneExt":41,"email":41},"Hana Kim, Professor",{"name":86,"role":90,"phone":41,"phoneExt":41,"email":41},"PRINCIPAL_INVESTIGATOR",{"facility":92,"status":73,"city":93,"state":93,"zip":94,"country":77,"countryCode":41,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Kangbuk Samsung Medical Center","Seoul","03181",{"type":79,"coordinates":96},[97,98],126.9784,37.566,{"lat":98,"lon":97},[101,102,103],{"name":64,"role":65,"phone":66,"phoneExt":41,"email":67},{"name":69,"role":65,"phone":41,"phoneExt":41,"email":41},{"name":64,"role":90,"phone":41,"phoneExt":41,"email":41},{"facility":105,"status":73,"city":93,"state":93,"zip":106,"country":77,"countryCode":41,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Yonsei University Health System, Severance Hospital","03722",{"type":79,"coordinates":108},[97,98],{"lat":98,"lon":97},[111,113,115],{"name":112,"role":65,"phone":66,"phoneExt":41,"email":67},"Jiwon Lee, Professor",{"name":114,"role":65,"phone":41,"phoneExt":41,"email":41},"Jia Lee, CRC",{"name":112,"role":90,"phone":41,"phoneExt":41,"email":41},{"type":117,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100593648",false,"NCT07009171","Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients","A Randomized, Double-blind, Placebo-controlled, Dose Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients","Inclusion Criteria:\n\n* Adult males and females aged 18 years or older (or the legal age of adulthood in the respective country) as of the date of written consent\n* Subjects with BMI ≥30 kg\u002Fm² or BMI ≥27 kg\u002Fm² with at least one weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea) at screening and baseline\n\n  * Hypertension: under treatment or have Systolic Blood Pressure (SBP) ≥130 mmHg or Diastolic Blood Pressure (DBP) ≥80 mmHg\n  * Dyslipidemia: under treatment or LDL \\> 160 mg\u002FdL or TG \\> 200 mg\u002FdL or HDL \\\u003C 40 mg\u002FdL\n  * Cardiovascular diseases (e.g., ischemic cardiovascular disease, NYHA Class I to III heart failure, Peripheral vascular disease (PVD), Abdominal aortic aneurysm (AAA), etc.)\n  * Obstructive sleep apnoea\n* Subjects who have documented a 500 kcal reduction\u002Fday in calorie intake and ≥150 minutes of physical activity\u002Fweek for ≥50% of the time during the run-in period\n* Subjects who have voluntarily provided written consent to participate after being informed about this clinical trial\n\nExclusion Criteria:\n\n* Subjects with a weight change of 5% or more within 12 weeks before screening\n* Subjects with less than 80% or more than 120% compliance during the Run-in period\n* Subjects with obesity due to secondary causes (neurological disorders, endocrine disorders, genetic disorders, congenital disorders, etc.)\n* Subjects with following medical history,\n\n  * Type 1 or Type 2 diabetes\n  * History of bariatric\u002Fmetabolic surgery (e.g., adjustable gastric banding, intragastric balloon insertion, sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion, duodenal switch) or planning to undergo such surgery during the study period\n  * Heart failure classified as NYHA class IV\n  * Subjects with a medical history of malignant tumors within 5 years prior to screening (however, subjects with successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or other carcinoma in situ, with no recurrence for more than 3 years, may be enrolled at the investigator's discretion)\n  * Subjects with a medical history of hypersensitivity to MAO inhibitors\n  * Subjects with a medical history of cerebrovascular disease (e.g., transient ischemic attack, stroke) within 12 weeks prior to baseline, or those hospitalized for unstable angina or congestive heart failure\n  * Subjects with a history of depressive disorders or psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorder) within 2 years prior to screening\n* Subjects with a history of the following drug administration,\n\n  \\-- Anti-obesity agents or weight-loss medications (including dietary supplements and herbal medicine) within 12 weeks before screening\n  * Corticosteroids administered for 2 consecutive weeks or more within 12 weeks before screening (however, topical preparations, including inhalants, are allowed)\n  * Treatment for hyperthyroidism or hypothyroidism at the time of screening (subjects on a stable dose and regimen for at least 12 weeks may be enrolled at the investigator's discretion)\n  * MAO inhibitors within 2 weeks before baseline\n  * Opioid medications (e.g., pethidine, Tramadol, Tapentadol) within 2 weeks before baseline\n  * Serotonergic drugs within 2 weeks before baseline,\n\n    * Selective Serotonin Reuptake Inhibitors (SSRI), ② Serotonin-Norepinephrine Reuptake Inhibitors (SNRI),\n\n      * Tricyclic or Tetracyclic antidepressant, ④ Triazolopyridine antidepressant, ⑤ Selective serotonin (5-HT1) agonists (Sumatriptan, etc.), (However, amitriptyline ≤50 mg\u002Fday, trazodone ≤100 mg\u002Fday, citalopram ≤20 mg\u002Fday, sertraline ≤100 mg\u002Fday, paroxetine ≤30 mg\u002Fday are allowed; long half-life serotonergic drugs (e.g., fluoxetine) require at least a 5-week wash out period before enrollment),\n  * Lithium, Bupropion, Lamotrigine, Ritonavir, Cyclobenzaprine, or St. John's wort within 2 weeks before baseline\n  * Hypertension crisis-inducing drugs (e.g., oxymetazoline, phentermine, phenylephrine) within 2 weeks before baseline\n  * Sympathomimetic agents (e.g., ephedrine, methylphenidate, amphetamine, methamphetamine, lisdexamfetamine) at the time of screening\n  * Dextromethorphan at the time of screening\n* Subjects who meet following criteria based on the tests conducted at Screening\n\n  * Glycated hemoglobin (HbA1c) ≥6.5%\n  * Hepatic impairment (Child-pugh class C)\n  * AST or ALT \\> 2.5 X ULN\n  * Total bilirubin \\>1.5 X ULN (however, \\>3.0 mg\u002FdL is acceptable in cases of Gilbert syndrome)\n  * Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² calculated using the MDRD formula\\*),\n\n    \\* eGFR = 175 X (Serum creatinine)-1.154 X (Age)-0.203 X (0.742 (for females)) X (1.212 (for African Americans))\n  * TSH \\>6.0 mIU\u002FL or \\\u003C0.4 mIU\u002FL,\n* Subjects with a lifetime history of suicide attempts\n* Subjects with a PHQ-9 score of 10 or higher at screening\n* Subjects who answer affirmatively to item 4 or 5 on the C-SSRS at screening\n* Pregnant or breastfeeding women\n* Females of childbearing potential and males who do not agree to use adequate contraception# until at least 2 weeks after the last dose of the IP or who plan to conceive during the study period,\n\n  * Adequate contraception is defined as double contraception using both barrier methods (male condom or female condom) and one of the contraceptive methods ①-③.\n\n    * Hormonal contraceptive (oral, injectable, implantable, etc.), ② Implantation of Intrauterine device (IUD) or intrauterine system (IUS), ③ Sterilization procedures or surgeries (bilateral tubal ligation, hysterectomy, vasectomy), ④ Complete abstinence: absolute abstinence is accepted if, in the investigator's judgment, the subject's age, occupation, lifestyle, or sexual orientation ensure compliance with contraception. However, periodic abstinence (calendar method, ovulation method, symptothermal method, etc.) withdrawal, and coitus interruptus are not considered adequate contraceptive methods.,\n* Subjects who have participated in another clinical trial and received an investigational drug or device within 4 weeks prior to screening\n* Other reasons (such as a medical history of alcohol or substance abuse) that the investigator deems the subject unsuitable for participation in this clinical trial","ALL","18 Years",{"count":127,"type":128},75,"ESTIMATED","INTERVENTIONAL",[131],"PHASE2","This is a randomized, double-blind, placebo-controlled, dose-finding, Phase 2a study designed to evaluate the safety and efficacy of KDS2010 in overweight or obese patients. Based on preliminary efficacy observed in the Phase 1 study, this clinical trial is being conducted in Korea.\n\nAfter a minimum 2-week run-in period, subjects who meet the inclusion and exclusion criteria will be randomized to the treatment group or placebo group at a 2:1 ratio in each stage.\n\nSubjects will receive the investigational product for 12 weeks following randomization. The study will be conducted in three stages.\n\nApproximately 75 subjects will be enrolled, with 6 subjects in the KDS2010 120 mg group and 3 subjects in the placebo group in Stage 1, 22 subjects in the KDS2010 180 mg group and 11 subjects in the placebo group in Stage 2, and 22 subjects in the KDS2010 240 mg group and 11 subjects in the placebo group in Stage 3.\n\nThe primary objectives are to assess the efficacy and safety of KDS2010 in overweight or obese patients. Exploratory objectives include evaluating the proportion of subjects achieving a weight reduction of more than 25% from baseline at Week 12 and assessing changes in MAO-B specific activity and adiponectin levels.\n\nBased on nonclinical and Phase 1 clinical data, KDS2010 will be administered orally once daily at doses of 120 mg, 180 mg, and 240 mg throughout the study.",[134,135,136],"Overweight","Obesity","Obese Patients",[136,134,38,135,138],"MAO-B inhibitor","2026-06-19",{"date":141,"type":142},"2026-06-24","ACTUAL",{"date":144,"type":142},"2025-07-29",{"date":146,"type":128},"2027-06-30",{"name":5,"class":6},3]