[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597406":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":51,"studyPopulation":51,"armGroups":65,"interventions":86,"overallOfficials":99,"centralContacts":103,"locations":109,"responsibleParty":562,"collaborators":51,"id":564,"slug":51,"hasResults":565,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":51,"eligibilityCriteria":569,"healthyVolunteers":565,"sex":570,"minAge":571,"maxAge":572,"enrollmentInfo":573,"targetDuration":51,"studyType":576,"phases":577,"briefSummary":580,"conditions":581,"keywords":51,"overallStatus":112,"whyStopped":51,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":592},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":51},[9,13,16,20,24],{"measure":10,"description":11,"timeFrame":12},"Part A: Maximum Plasma Concentration (Cmax) of Enlicitide","Blood samples will be collected to determine the Cmax of enlicitide.","At designated timepoints (up to 24 hours postdose on day 14)",{"measure":14,"description":15,"timeFrame":12},"Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide","Blood samples will be collected to determine the AUC0-24 of enlicitide.",{"measure":17,"description":18,"timeFrame":19},"Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)","Blood samples will be collected to determine the percent change from baseline in LDL-C.","Baseline and Week 24",{"measure":21,"description":22,"timeFrame":23},"Number of Participants Who Experience an Adverse Event (AE)","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.","Up to approximately 188 weeks",{"measure":25,"description":22,"timeFrame":26},"Number of Participants Who Discontinue Study Treatment Due to an AE","Up to approximately 180 weeks",[28,32,35,38,42,45,48],{"measure":29,"description":30,"timeFrame":31},"Part B: Percent Change from Baseline in Apolipoprotein B (ApoB)","Blood samples will be collected to determine the percent change from baseline in apolipoprotein B.","Baseline and week 24",{"measure":33,"description":34,"timeFrame":31},"Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)","Blood samples will be collected to determine the percent change from baseline in non-HDL-C.",{"measure":36,"description":37,"timeFrame":31},"Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a))","Blood samples will be collected to determine the percent change from baseline in Lp(a).",{"measure":39,"description":40,"timeFrame":41},"Part B: Percentage of Participants With LDL-C \u003C130 mg\u002FdL at Week 24","The percentage of participants with LDL-C \\\u003C130 mg\u002FdL at week 24 will be reported.","Week 24",{"measure":43,"description":44,"timeFrame":31},"Part B: Percentage of Participants With ≥50% LDL-C Reduction from Baseline at Week 24","The percentage of participants with ≥50% LDL-C reduction from baseline at week 24 will be reported.",{"measure":46,"description":47,"timeFrame":41},"Part B: Percentage of Participants With LDL-C \u003C100 mg\u002FdL at Week 24","The percentage of participants with LDL-C \\\u003C100 mg\u002FdL at week 24 will be reported.",{"measure":49,"description":50,"timeFrame":31},"Change in Carotid Intima-media Thickness (cIMT)","Ultrasound measurements will be performed to determine the change from baseline in cIMT.",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":51,"timePerspective":51,"maskingInfo":57},"RANDOMIZED","PARALLEL","There are two parts of the study. Part A is a non randomized single treatment group. Part B is randomized parallel treatment groups. Participants who complete either part are then eligible to enroll in an open label extension (single group).","TREATMENT",{"masking":58,"maskingDescription":59,"whoMasked":60},"QUADRUPLE","Part A and the extension period are open-label. Part B is double-blinded.",[61,62,63,64],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[66,72,76,82],{"label":67,"type":68,"description":69,"interventionNames":70},"Part A: Enlicitide Decanoate","EXPERIMENTAL","Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks.",[71],"Drug: Enlicitide Decanoate",{"label":73,"type":68,"description":74,"interventionNames":75},"Part B: Enlicitide Decanoate","Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks.",[71],{"label":77,"type":78,"description":79,"interventionNames":80},"Part B: Placebo","PLACEBO_COMPARATOR","Participants receive placebo orally QD for up to 24 weeks.",[81],"Drug: Placebo",{"label":83,"type":68,"description":84,"interventionNames":85},"Open-Label Extension: Enlicitide Decanoate","Participants who complete either Part A or Part B may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate QD at a dosage determined by age for up to 3 years.",[71],[87,95],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"DRUG","Enlicitide Decanoate","Enlicitide decanoate taken by mouth",[83,67,73],[93,94],"MK-0616","Enlicitide",{"type":88,"name":96,"description":97,"armGroupLabels":98,"otherNames":51},"Placebo","Placebo tablet matched to enlicitide decanoate taken by mouth",[77],[100],{"name":101,"affiliation":5,"role":102},"Medical Director","STUDY_DIRECTOR",[104],{"name":105,"role":106,"phone":107,"phoneExt":51,"email":108},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[110,128,141,154,167,180,193,208,223,238,250,265,274,289,302,315,330,343,356,369,384,399,414,427,439,454,469,483,498,511,524,538,550],{"facility":111,"status":112,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Nemours\u002FAlfred I. duPont Hospital for Children ( Site 0001)","RECRUITING","Wilmington","Delaware","19803","United States","US",{"type":119,"coordinates":120},"Point",[121,122],-75.54659,39.74595,{"lat":122,"lon":121},[125],{"name":126,"role":106,"phone":127,"phoneExt":51,"email":51},"Study Coordinator","302-651-6600",{"facility":129,"status":112,"city":130,"state":131,"zip":132,"country":116,"countryCode":117,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Children's National Medical Center ( Site 0015)","Washington D.C.","District of Columbia","20010",{"type":119,"coordinates":134},[135,136],-77.03637,38.89511,{"lat":136,"lon":135},[139],{"name":126,"role":106,"phone":140,"phoneExt":51,"email":51},"202-476-5000",{"facility":142,"status":112,"city":143,"state":144,"zip":145,"country":116,"countryCode":117,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Excel Medical Clinical Trials ( Site 0008)","Boca Raton","Florida","33434",{"type":119,"coordinates":147},[148,149],-80.0831,26.35869,{"lat":149,"lon":148},[152],{"name":126,"role":106,"phone":153,"phoneExt":51,"email":51},"561-529-4356",{"facility":155,"status":112,"city":156,"state":157,"zip":158,"country":116,"countryCode":117,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Children's Healthcare of Atlanta Cardiology ( Site 0026)","Atlanta","Georgia","30329",{"type":119,"coordinates":160},[161,162],-84.38798,33.749,{"lat":162,"lon":161},[165],{"name":126,"role":106,"phone":166,"phoneExt":51,"email":51},"404-256-2593",{"facility":168,"status":112,"city":169,"state":170,"zip":171,"country":116,"countryCode":117,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Cincinnati Children's Hospital Medical Center ( Site 0016)","Cincinnati","Ohio","45229",{"type":119,"coordinates":173},[174,175],-84.51439,39.12711,{"lat":175,"lon":174},[178],{"name":126,"role":106,"phone":179,"phoneExt":51,"email":51},"513-636-3200",{"facility":181,"status":112,"city":182,"state":183,"zip":184,"country":116,"countryCode":117,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"West Virginia University ( Site 0013)","Morgantown","West Virginia","26506",{"type":119,"coordinates":186},[187,188],-79.9559,39.62953,{"lat":188,"lon":187},[191],{"name":126,"role":106,"phone":192,"phoneExt":51,"email":51},"304-598-4000",{"facility":194,"status":112,"city":195,"state":196,"zip":197,"country":198,"countryCode":199,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Monash Children s Hospital ( Site 1603)","Clayton","Victoria","3168","Australia","AU",{"type":119,"coordinates":201},[202,203],145.11667,-37.91667,{"lat":203,"lon":202},[206],{"name":126,"role":106,"phone":207,"phoneExt":51,"email":51},"+61385723000",{"facility":209,"status":112,"city":210,"state":211,"zip":212,"country":213,"countryCode":214,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"UZ Antwerpen ( Site 0601)","Edegem","Antwerpen","2650","Belgium","BE",{"type":119,"coordinates":216},[217,218],4.44504,51.15662,{"lat":218,"lon":217},[221],{"name":126,"role":106,"phone":222,"phoneExt":51,"email":51},"+323 821 32 51",{"facility":224,"status":112,"city":225,"state":226,"zip":227,"country":228,"countryCode":229,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Universidade Federal Do Ceara ( Site 0201)","Fortaleza","Ceará","60430270","Brazil","BR",{"type":119,"coordinates":231},[232,233],-38.54306,-3.71722,{"lat":233,"lon":232},[236],{"name":126,"role":106,"phone":237,"phoneExt":51,"email":51},"+558533668590",{"facility":239,"status":112,"city":240,"state":51,"zip":241,"country":228,"countryCode":229,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"Incor - 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Capital Medical University ( Site 1917)","Beijing","Beijing Municipality","100029","China","CN",{"type":119,"coordinates":282},[283,284],116.39723,39.9075,{"lat":284,"lon":283},[287],{"name":126,"role":106,"phone":288,"phoneExt":51,"email":51},"010-64412431",{"facility":290,"status":112,"city":291,"state":292,"zip":293,"country":279,"countryCode":280,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"Shanghai Children's Medical Center ( Site 1918)","Shanghai","Shanghai Municipality","200120",{"type":119,"coordinates":295},[296,297],121.45806,31.22222,{"lat":297,"lon":296},[300],{"name":126,"role":106,"phone":301,"phoneExt":51,"email":51},"021-38626161",{"facility":303,"status":112,"city":304,"state":305,"zip":306,"country":279,"countryCode":280,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)","Hangzhou","Zhejiang","310057",{"type":119,"coordinates":308},[309,310],120.16142,30.29365,{"lat":310,"lon":309},[313],{"name":126,"role":106,"phone":314,"phoneExt":51,"email":51},"0571-86036545",{"facility":316,"status":112,"city":317,"state":318,"zip":319,"country":320,"countryCode":321,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"Clinica de la Costa S.A.S. ( Site 0400)","Barranquilla","Atlántico","080020","Colombia","CO",{"type":119,"coordinates":323},[324,325],-74.78132,10.96854,{"lat":325,"lon":324},[328],{"name":126,"role":106,"phone":329,"phoneExt":51,"email":51},"+57 3133894240",{"facility":331,"status":112,"city":332,"state":333,"zip":334,"country":320,"countryCode":321,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"Oncomédica S.A.S ( Site 0401)","Montería","Departamento de Córdoba","230002",{"type":119,"coordinates":336},[337,338],-75.87823,8.75081,{"lat":338,"lon":337},[341],{"name":126,"role":106,"phone":342,"phoneExt":51,"email":51},"+57 3135342052",{"facility":344,"status":112,"city":345,"state":346,"zip":347,"country":320,"countryCode":321,"cosmosGeoPoint":348,"geoPoint":352,"contacts":353},"Fundación Cardiovascular de Colombia ( Site 0402)","Piedecuesta","Santander Department","681017",{"type":119,"coordinates":349},[350,351],-73.04953,6.98789,{"lat":351,"lon":350},[354],{"name":126,"role":106,"phone":355,"phoneExt":51,"email":51},"+573203400438",{"facility":357,"status":112,"city":358,"state":359,"zip":360,"country":320,"countryCode":321,"cosmosGeoPoint":361,"geoPoint":365,"contacts":366},"Fundacion Valle del Lili ( Site 0403)","Cali","Valle del Cauca Department","760032",{"type":119,"coordinates":362},[363,364],-76.5199,3.43054,{"lat":364,"lon":363},[367],{"name":126,"role":106,"phone":368,"phoneExt":51,"email":51},"+573166237452",{"facility":370,"status":112,"city":371,"state":372,"zip":373,"country":374,"countryCode":375,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"New Childrens Hospital ( Site 0800)","Helsinki","Uusimaa","00029","Finland","FI",{"type":119,"coordinates":377},[378,379],24.93545,60.16952,{"lat":379,"lon":378},[382],{"name":126,"role":106,"phone":383,"phoneExt":51,"email":51},"+358 9 4711",{"facility":385,"status":112,"city":386,"state":387,"zip":388,"country":389,"countryCode":390,"cosmosGeoPoint":391,"geoPoint":395,"contacts":396},"Universitaetsklinikum Freiburg ( Site 2203)","Freiburg im Breisgau","Baden-Wurttemberg","79106","Germany","DE",{"type":119,"coordinates":392},[393,394],7.85222,47.9959,{"lat":394,"lon":393},[397],{"name":126,"role":106,"phone":398,"phoneExt":51,"email":51},"+49 761 270 - 43000",{"facility":400,"status":112,"city":401,"state":402,"zip":403,"country":404,"countryCode":405,"cosmosGeoPoint":406,"geoPoint":410,"contacts":411},"Hospital Universitario \"Dr. Jose Eleuterio Gonzalez\" ( Site 0501)","Monterrey","Nuevo León","64460","Mexico","MX",{"type":119,"coordinates":407},[408,409],-100.31721,25.68435,{"lat":409,"lon":408},[412],{"name":126,"role":106,"phone":413,"phoneExt":51,"email":51},"+52 8183338623",{"facility":415,"status":112,"city":416,"state":417,"zip":418,"country":404,"countryCode":405,"cosmosGeoPoint":419,"geoPoint":423,"contacts":424},"Centro de Investigacion Clinica de Oaxaca ( Site 0505)","Oaxaca City","Oaxaca","68020",{"type":119,"coordinates":420},[421,422],-96.72544,17.06025,{"lat":422,"lon":421},[425],{"name":126,"role":106,"phone":426,"phoneExt":51,"email":51},"+52 9516035559",{"facility":428,"status":112,"city":429,"state":51,"zip":430,"country":404,"countryCode":405,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"INVECORDIS S.C. ( Site 0503)","Huixquilucan","52763",{"type":119,"coordinates":432},[433,434],-99.35016,19.35985,{"lat":434,"lon":433},[437],{"name":126,"role":106,"phone":438,"phoneExt":51,"email":51},"+525552469710",{"facility":440,"status":112,"city":441,"state":442,"zip":443,"country":444,"countryCode":445,"cosmosGeoPoint":446,"geoPoint":450,"contacts":451},"Amsterdam UMC, locatie AMC ( Site 1000)","Amsterdam","North Holland","1105 AZ","Netherlands","NL",{"type":119,"coordinates":447},[448,449],4.88969,52.37403,{"lat":449,"lon":448},[452],{"name":126,"role":106,"phone":453,"phoneExt":51,"email":51},"+31205666360",{"facility":455,"status":112,"city":456,"state":457,"zip":458,"country":459,"countryCode":460,"cosmosGeoPoint":461,"geoPoint":465,"contacts":466},"New Zealand Clinical Research (Christchurch) ( Site 1700)","Christchurch","Canterbury","8011","New Zealand","NZ",{"type":119,"coordinates":462},[463,464],172.63333,-43.53333,{"lat":464,"lon":463},[467],{"name":126,"role":106,"phone":468,"phoneExt":51,"email":51},"NZCR +6433729477",{"facility":470,"status":112,"city":471,"state":472,"zip":473,"country":471,"countryCode":474,"cosmosGeoPoint":475,"geoPoint":479,"contacts":480},"National University Hospital-Paediatrics ( Site 1800)","Singapore","Central Singapore","117599","SG",{"type":119,"coordinates":476},[477,478],103.85007,1.28967,{"lat":478,"lon":477},[481],{"name":126,"role":106,"phone":482,"phoneExt":51,"email":51},"+6567795555",{"facility":484,"status":112,"city":485,"state":486,"zip":487,"country":488,"countryCode":489,"cosmosGeoPoint":490,"geoPoint":494,"contacts":495},"Hospital Universitario Central de Asturias ( Site 1303)","Oviedo","Asturias, Principado de","33011","Spain","ES",{"type":119,"coordinates":491},[492,493],-5.84476,43.36029,{"lat":493,"lon":492},[496],{"name":126,"role":106,"phone":497,"phoneExt":51,"email":51},"+34985108000",{"facility":499,"status":112,"city":500,"state":501,"zip":502,"country":488,"countryCode":489,"cosmosGeoPoint":503,"geoPoint":507,"contacts":508},"Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)","Santiago de Compostela","La Coruna","15706",{"type":119,"coordinates":504},[505,506],-8.54569,42.88052,{"lat":506,"lon":505},[509],{"name":126,"role":106,"phone":510,"phoneExt":51,"email":51},"+34981951108",{"facility":512,"status":112,"city":513,"state":514,"zip":515,"country":488,"countryCode":489,"cosmosGeoPoint":516,"geoPoint":520,"contacts":521},"COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)","Pamplona","Navarre","31009",{"type":119,"coordinates":517},[518,519],-1.64323,42.81687,{"lat":519,"lon":518},[522],{"name":126,"role":106,"phone":523,"phoneExt":51,"email":51},"+34660021505",{"facility":525,"status":112,"city":526,"state":51,"zip":527,"country":528,"countryCode":529,"cosmosGeoPoint":530,"geoPoint":534,"contacts":535},"Birmingham Childrens Hospital ( Site 1501)","Birmingham","B4 6NH","United Kingdom","UK",{"type":119,"coordinates":531},[532,533],-1.89983,52.48142,{"lat":533,"lon":532},[536],{"name":126,"role":106,"phone":537,"phoneExt":51,"email":51},"+441213338504",{"facility":539,"status":112,"city":540,"state":51,"zip":541,"country":528,"countryCode":529,"cosmosGeoPoint":542,"geoPoint":546,"contacts":547},"Sheffield Childrens Hospital ( Site 1503)","Sheffield","S10 2TH",{"type":119,"coordinates":543},[544,545],-1.4659,53.38297,{"lat":545,"lon":544},[548],{"name":126,"role":106,"phone":549,"phoneExt":51,"email":51},"+441142717000",{"facility":551,"status":112,"city":552,"state":51,"zip":553,"country":528,"countryCode":529,"cosmosGeoPoint":554,"geoPoint":558,"contacts":559},"Southampton General Hospital ( Site 1502)","Southampton","SO16 6YD",{"type":119,"coordinates":555},[556,557],-1.40428,50.90395,{"lat":557,"lon":556},[560],{"name":126,"role":106,"phone":561,"phoneExt":51,"email":51},"+442381204989",{"type":563,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100597406",false,"NCT07058077","A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)","An Operationally Seamless Phase 2\u002F3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia","Inclusion Criteria:\n\nInclusion criteria include, but are not limited to:\n\n* Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results\n* Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg\u002FdL\n* Is receiving either:\n\n  * An optimized daily dose of statin (± nonstatin LLT)\n  * A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative\n* Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to:\n\n* Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH\n* Has a history of nephrotic syndrome\n* Has any clinically significant malabsorption condition based on investigator assessment\n* Was previously treated\u002Fis being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin\u002Fkexin type 9 (PCSK9) inhibitors without adequate washout","ALL","6 Years","17 Years",{"count":574,"type":575},153,"ESTIMATED","INTERVENTIONAL",[578,579],"PHASE2","PHASE3","This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.\n\nThe goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.",[582],"Heterozygous Familial Hypercholesterolemia (HeFH)","2026-07-01",{"date":585,"type":586},"2026-07-02","ACTUAL",{"date":588,"type":586},"2025-08-21",{"date":590,"type":575},"2037-01-23",{"name":5,"class":6},33]