[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07058077":3,"trial-entities:NCT07058077":597,"trial-summary:NCT07058077":601},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":46,"secondary_outcomes":65,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":107,"locations":109,"central_contacts":580,"overall_officials":585,"references":589,"see_also_links":590},"NCT07058077","0616-029","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","RECRUITING","2037-01-23","2026-09","2026-09-14","2025-08-21","Merck Sharp & Dohme LLC","INDUSTRY",true,"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.",null,[19],"Heterozygous Familial Hypercholesterolemia (HeFH)",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE2","PHASE3",{"count":27,"type":28},153,"ESTIMATED",[30,41],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":38},"DRUG","Enlicitide Decanoate","Enlicitide decanoate taken by mouth",[35,36,37],"Open-Label Extension: Enlicitide Decanoate","Part A: Enlicitide Decanoate","Part B: Enlicitide Decanoate",[39,40],"MK-0616","Enlicitide",{"type":31,"name":42,"description":43,"armGroupLabels":44},"Placebo","Placebo tablet matched to enlicitide decanoate taken by mouth",[45],"Part B: Placebo",[47,51,54,58,62],{"measure":48,"description":49,"timeFrame":50},"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":52,"description":53,"timeFrame":50},"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":55,"description":56,"timeFrame":57},"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":59,"description":60,"timeFrame":61},"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":63,"description":60,"timeFrame":64},"Number of Participants Who Discontinue Study Treatment Due to an AE","Up to approximately 180 weeks",[66,70,73,76,80,83,86],{"measure":67,"description":68,"timeFrame":69},"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":71,"description":72,"timeFrame":69},"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":74,"description":75,"timeFrame":69},"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":77,"description":78,"timeFrame":79},"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":81,"description":82,"timeFrame":69},"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":84,"description":85,"timeFrame":79},"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":87,"description":88,"timeFrame":69},"Change in Carotid Intima-media Thickness (cIMT)","Ultrasound measurements will be performed to determine the change from baseline in cIMT.","ALL","6 Years","17 Years",false,{"inclusion":94,"exclusion":101,"raw_text":106},[95,96,97,98,99,100],"Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results","Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg\u002FdL","Is receiving either:","An optimized daily dose of statin (± nonstatin LLT)","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","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",[102,103,104,105],"Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH","Has a history of nephrotic syndrome","Has any clinically significant malabsorption condition based on investigator assessment","Was previously treated\u002Fis being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin\u002Fkexin type 9 (PCSK9) inhibitors without adequate washout","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",[108],"CHILD",[110,124,135,146,157,168,179,190,202,213,225,237,247,254,266,273,285,292,303,314,321,332,344,355,366,377,389,399,411,423,435,447,458,468,480,492,504,515,527,538,549,560,570],{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":115,"contacts":116,"geoPoint":121},"Nemours\u002FAlfred I. duPont Hospital for Children ( Site 0001)","Wilmington","Delaware","19803","United States",[117],{"name":118,"role":119,"phone":120},"Study Coordinator","CONTACT","302-651-6600",{"lat":122,"lon":123},39.74595,-75.54659,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":115,"contacts":129,"geoPoint":132},"Children's National Medical Center ( Site 0015)","Washington D.C.","District of Columbia","20010",[130],{"name":118,"role":119,"phone":131},"202-476-5000",{"lat":133,"lon":134},38.89511,-77.03637,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":115,"contacts":140,"geoPoint":143},"Excel Medical Clinical Trials ( Site 0008)","Boca Raton","Florida","33434",[141],{"name":118,"role":119,"phone":142},"561-529-4356",{"lat":144,"lon":145},26.35869,-80.0831,{"facility":147,"status":8,"city":148,"state":149,"zip":150,"country":115,"contacts":151,"geoPoint":154},"Children's Healthcare of Atlanta Cardiology ( Site 0026)","Atlanta","Georgia","30329",[152],{"name":118,"role":119,"phone":153},"404-256-2593",{"lat":155,"lon":156},33.749,-84.38798,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":115,"contacts":162,"geoPoint":165},"Boston Children's Hospital ( Site 0018)","Boston","Massachusetts","02115",[163],{"name":118,"role":119,"phone":164},"616-354-3372",{"lat":166,"lon":167},42.35843,-71.05977,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":115,"contacts":173,"geoPoint":176},"Cincinnati Children's Hospital Medical Center ( Site 0016)","Cincinnati","Ohio","45229",[174],{"name":118,"role":119,"phone":175},"513-636-3200",{"lat":177,"lon":178},39.12711,-84.51439,{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":115,"contacts":184,"geoPoint":187},"West Virginia University ( Site 0013)","Morgantown","West Virginia","26506",[185],{"name":118,"role":119,"phone":186},"304-598-4000",{"lat":188,"lon":189},39.62953,-79.9559,{"facility":191,"status":8,"city":192,"state":193,"zip":194,"country":195,"contacts":196,"geoPoint":199},"Monash Children s Hospital ( Site 1603)","Clayton","Victoria","3168","Australia",[197],{"name":118,"role":119,"phone":198},"+61385723000",{"lat":200,"lon":201},-37.91667,145.11667,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":195,"contacts":207,"geoPoint":210},"Perth Children s Hospital ( Site 1601)","Nedlands","Western Australia","6909",[208],{"name":118,"role":119,"phone":209},"+61864565671",{"lat":211,"lon":212},-31.98184,115.8073,{"facility":214,"status":8,"city":215,"state":216,"zip":217,"country":218,"contacts":219,"geoPoint":222},"UZ Antwerpen ( Site 0601)","Edegem","Antwerpen","2650","Belgium",[220],{"name":118,"role":119,"phone":221},"+323 821 32 51",{"lat":223,"lon":224},51.15662,4.44504,{"facility":226,"status":8,"city":227,"state":228,"zip":229,"country":230,"contacts":231,"geoPoint":234},"Universidade Federal Do Ceara ( Site 0201)","Fortaleza","Ceará","60430270","Brazil",[232],{"name":118,"role":119,"phone":233},"+558533668590",{"lat":235,"lon":236},-3.71722,-38.54306,{"facility":238,"status":8,"city":239,"zip":240,"country":230,"contacts":241,"geoPoint":244},"Instituto Dante Pazzanese de Cardiology ( Site 0206)","São Paulo","04012-909",[242],{"name":118,"role":119,"phone":243},"+551150856419",{"lat":245,"lon":246},-23.5475,-46.63611,{"facility":248,"status":8,"city":239,"zip":249,"country":230,"contacts":250,"geoPoint":253},"Incor - Instituto do Coracao ( Site 0200)","05403900",[251],{"name":118,"role":119,"phone":252},"+551126615450",{"lat":245,"lon":246},{"facility":255,"status":8,"city":256,"state":257,"zip":258,"country":259,"contacts":260,"geoPoint":263},"Explora Salud ( Site 0304)","Santiago","Region M. de Santiago","7500504","Chile",[261],{"name":118,"role":119,"phone":262},"+56944213579",{"lat":264,"lon":265},-33.45694,-70.64827,{"facility":267,"status":8,"city":256,"state":257,"zip":268,"country":259,"contacts":269,"geoPoint":272},"Pontificia Universidad Catolica de Chile ( Site 0300)","8330032",[270],{"name":118,"role":119,"phone":271},"56934331806",{"lat":264,"lon":265},{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":278,"contacts":279,"geoPoint":282},"Children's Hospital Capital Institute of Pediatrics ( Site 1908)","Beijing","Beijing Municipality","100020","China",[280],{"name":118,"role":119,"phone":281},"010-85695555",{"lat":283,"lon":284},39.9075,116.39723,{"facility":286,"status":8,"city":275,"state":276,"zip":287,"country":278,"contacts":288,"geoPoint":291},"Beijing Anzhen Hospital. Capital Medical University ( Site 1917)","100029",[289],{"name":118,"role":119,"phone":290},"010-64412431",{"lat":283,"lon":284},{"facility":293,"status":8,"city":294,"state":295,"zip":296,"country":278,"contacts":297,"geoPoint":300},"Guangdong Provincial People's Hospital ( Site 1915)","Guangzhou","Guangdong","510080",[298],{"name":118,"role":119,"phone":299},"02083882222",{"lat":301,"lon":302},23.11667,113.25,{"facility":304,"status":8,"city":305,"state":306,"zip":307,"country":278,"contacts":308,"geoPoint":311},"Children's Hospital of Fudan University ( Site 1906)","Shanghai","Shanghai Municipality","200032",[309],{"name":118,"role":119,"phone":310},"021-96999176",{"lat":312,"lon":313},31.22222,121.45806,{"facility":315,"status":8,"city":305,"state":306,"zip":316,"country":278,"contacts":317,"geoPoint":320},"Shanghai Children's Medical Center ( Site 1918)","200120",[318],{"name":118,"role":119,"phone":319},"021-38626161",{"lat":312,"lon":313},{"facility":322,"status":8,"city":323,"state":324,"zip":325,"country":278,"contacts":326,"geoPoint":329},"The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)","Hangzhou","Zhejiang","310057",[327],{"name":118,"role":119,"phone":328},"0571-86036545",{"lat":330,"lon":331},30.29365,120.16142,{"facility":333,"status":8,"city":334,"state":335,"zip":336,"country":337,"contacts":338,"geoPoint":341},"Clinica de la Costa S.A.S. ( Site 0400)","Barranquilla","Atlántico","080020","Colombia",[339],{"name":118,"role":119,"phone":340},"+57 3133894240",{"lat":342,"lon":343},10.96854,-74.78132,{"facility":345,"status":8,"city":346,"state":347,"zip":348,"country":337,"contacts":349,"geoPoint":352},"Oncomédica S.A.S ( Site 0401)","Montería","Departamento de Córdoba","230002",[350],{"name":118,"role":119,"phone":351},"+57 3135342052",{"lat":353,"lon":354},8.75081,-75.87823,{"facility":356,"status":8,"city":357,"state":358,"zip":359,"country":337,"contacts":360,"geoPoint":363},"Fundación Cardiovascular de Colombia ( Site 0402)","Piedecuesta","Santander Department","681017",[361],{"name":118,"role":119,"phone":362},"+573203400438",{"lat":364,"lon":365},6.98789,-73.04953,{"facility":367,"status":8,"city":368,"state":369,"zip":370,"country":337,"contacts":371,"geoPoint":374},"Fundacion Valle del Lili ( Site 0403)","Cali","Valle del Cauca Department","760032",[372],{"name":118,"role":119,"phone":373},"+573166237452",{"lat":375,"lon":376},3.43054,-76.5199,{"facility":378,"status":8,"city":379,"state":380,"zip":381,"country":382,"contacts":383,"geoPoint":386},"Detska nemocnice FN Brno ( Site 0701)","Brno","Brno-mesto","613 00","Czechia",[384],{"name":118,"role":119,"phone":385},"+420532231111",{"lat":387,"lon":388},49.19522,16.60796,{"facility":390,"status":8,"city":391,"zip":392,"country":382,"contacts":393,"geoPoint":396},"Fakultni nemocnice v Motole ( Site 0700)","Prague","150 00",[394],{"name":118,"role":119,"phone":395},"+420224435332",{"lat":397,"lon":398},50.08804,14.42076,{"facility":400,"status":8,"city":401,"state":402,"zip":403,"country":404,"contacts":405,"geoPoint":408},"New Childrens Hospital ( Site 0800)","Helsinki","Uusimaa","00029","Finland",[406],{"name":118,"role":119,"phone":407},"+358 9 4711",{"lat":409,"lon":410},60.16952,24.93545,{"facility":412,"status":8,"city":413,"state":414,"zip":415,"country":416,"contacts":417,"geoPoint":420},"Hopital Femme Mere Enfant ( Site 2101)","Bron","Rhone","69500","France",[418],{"name":118,"role":119,"phone":419},"+33472357050",{"lat":421,"lon":422},45.73865,4.91303,{"facility":424,"status":8,"city":425,"state":426,"zip":427,"country":428,"contacts":429,"geoPoint":432},"Universitaetsklinikum Freiburg ( Site 2203)","Freiburg im Breisgau","Baden-Wurttemberg","79106","Germany",[430],{"name":118,"role":119,"phone":431},"+49 761 270 - 43000",{"lat":433,"lon":434},47.9959,7.85222,{"facility":436,"status":8,"city":437,"state":438,"zip":439,"country":440,"contacts":441,"geoPoint":444},"Laboratorio de Patología Clínica del Hospital Universitario \"Dr. José Eleuterio González\" ( Site 0501)","Monterrey","Nuevo León","64460","Mexico",[442],{"name":118,"role":119,"phone":443},"+52 8183338623",{"lat":445,"lon":446},25.68435,-100.31721,{"facility":448,"status":8,"city":449,"state":450,"zip":451,"country":440,"contacts":452,"geoPoint":455},"Centro de Investigacion Clinica de Oaxaca ( Site 0505)","Oaxaca City","Oaxaca","68020",[453],{"name":118,"role":119,"phone":454},"+52 9516035559",{"lat":456,"lon":457},17.06025,-96.72544,{"facility":459,"status":8,"city":460,"zip":461,"country":440,"contacts":462,"geoPoint":465},"INVECORDIS S.C. ( Site 0503)","Huixquilucan","52763",[463],{"name":118,"role":119,"phone":464},"+525552469710",{"lat":466,"lon":467},19.35985,-99.35016,{"facility":469,"status":8,"city":470,"state":471,"zip":472,"country":473,"contacts":474,"geoPoint":477},"Amsterdam UMC, locatie AMC ( Site 1000)","Amsterdam","North Holland","1105 AZ","Netherlands",[475],{"name":118,"role":119,"phone":476},"+31205666360",{"lat":478,"lon":479},52.37403,4.88969,{"facility":481,"status":8,"city":482,"state":483,"zip":484,"country":485,"contacts":486,"geoPoint":489},"New Zealand Clinical Research (Christchurch) ( Site 1700)","Christchurch","Canterbury","8011","New Zealand",[487],{"name":118,"role":119,"phone":488},"NZCR +6433729477",{"lat":490,"lon":491},-43.53333,172.63333,{"facility":493,"status":8,"city":494,"state":495,"zip":496,"country":497,"contacts":498,"geoPoint":501},"Instytut Centrum Zdrowia Matki Polki ( Site 1201)","Lodz","Łódź Voivodeship","93-338","Poland",[499],{"name":118,"role":119,"phone":500},"+48422711266",{"lat":502,"lon":503},51.77058,19.47395,{"facility":505,"status":8,"city":506,"state":507,"zip":508,"country":506,"contacts":509,"geoPoint":512},"National University Hospital-Paediatrics ( Site 1800)","Singapore","Central Singapore","117599",[510],{"name":118,"role":119,"phone":511},"+6567795555",{"lat":513,"lon":514},1.28967,103.85007,{"facility":516,"status":8,"city":517,"state":518,"zip":519,"country":520,"contacts":521,"geoPoint":524},"Hospital Universitario Central de Asturias ( Site 1303)","Oviedo","Asturias, Principado de","33011","Spain",[522],{"name":118,"role":119,"phone":523},"+34985108000",{"lat":525,"lon":526},43.36029,-5.84476,{"facility":528,"status":8,"city":529,"state":530,"zip":531,"country":520,"contacts":532,"geoPoint":535},"Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)","Santiago de Compostela","La Coruna","15706",[533],{"name":118,"role":119,"phone":534},"+34981951108",{"lat":536,"lon":537},42.88052,-8.54569,{"facility":539,"status":8,"city":540,"state":541,"zip":542,"country":520,"contacts":543,"geoPoint":546},"COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)","Pamplona","Navarre","31009",[544],{"name":118,"role":119,"phone":545},"+34660021505",{"lat":547,"lon":548},42.81687,-1.64323,{"facility":550,"status":8,"city":551,"zip":552,"country":553,"contacts":554,"geoPoint":557},"Birmingham Childrens Hospital ( Site 1501)","Birmingham","B4 6NH","United Kingdom",[555],{"name":118,"role":119,"phone":556},"+441213338504",{"lat":558,"lon":559},52.48142,-1.89983,{"facility":561,"status":8,"city":562,"zip":563,"country":553,"contacts":564,"geoPoint":567},"Sheffield Childrens Hospital ( Site 1503)","Sheffield","S10 2TH",[565],{"name":118,"role":119,"phone":566},"+441142717000",{"lat":568,"lon":569},53.38297,-1.4659,{"facility":571,"status":8,"city":572,"zip":573,"country":553,"contacts":574,"geoPoint":577},"Southampton General Hospital ( Site 1502)","Southampton","SO16 6YD",[575],{"name":118,"role":119,"phone":576},"+442381204989",{"lat":578,"lon":579},50.90395,-1.40428,[581],{"name":582,"role":119,"phone":583,"email":584},"Toll Free Number","1-888-577-8839","Trialsites@msd.com",[586],{"name":587,"affiliation":13,"role":588},"Medical Director","STUDY_DIRECTOR",[],[591,594],{"label":592,"url":593},"Merck Clinical Trials Information","http:\u002F\u002Fwww.merckclinicaltrials.com",{"label":595,"url":596},"Plain Language Summary","https:\u002F\u002Fwww.trialsummaries.com\u002FStudy\u002FStudyDetails?id=27198&tenant=MT_MSD_9011",{"nct_id":4,"conditions":598,"biomarkers":600},[599],"Familial hypercholesterolemia - heterozygous",[],{"nct_id":4,"found":15,"summary":602,"prompt_version":612},{"design":603,"status":604,"heading":605,"summary":606,"follow_up":607,"word_count":608,"commitments":609,"compensation":610,"drugs_mentioned":611},"This is an interventional study comparing enlicitide decanoate to a placebo. It plans to enroll 153 participants aged 6 to 17 years.","completed","Enlicitide Decanoate for Children with High Cholesterol (HeFH)","This study is testing a new oral medication called enlicitide decanoate for children and adolescents (ages 6-17) who have Heterozygous Familial Hypercholesterolemia (HeFH). HeFH is a genetic condition that causes very high levels of \"bad\" cholesterol (LDL-C). The study aims to find out if enlicitide decanoate is safe, how well children tolerate it, how the body processes the medication, and if it can effectively lower LDL-C levels compared to a placebo (a pill with no active medicine). To join, participants must have a confirmed or suspected diagnosis of HeFH and high LDL-C, even while on other cholesterol-lowering treatments. The study plans to enroll 153 participants.","Cholesterol levels will be measured at baseline and again at Week 24. Drug levels in the blood will be measured up to 24 hours after a dose on day 14.",105,"Not specified in the trial record.","Not stated in the trial record.",[32,42],"v2"]