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1302)","Pamplona","Navarre","31009",{"type":119,"coordinates":689},[690,691],-1.64323,42.81687,{"lat":691,"lon":690},[694],{"name":126,"role":106,"phone":695,"phoneExt":51,"email":51},"+34660021505",{"facility":697,"status":112,"city":698,"state":51,"zip":699,"country":700,"countryCode":701,"cosmosGeoPoint":702,"geoPoint":706,"contacts":707},"Birmingham Childrens Hospital ( Site 1501)","Birmingham","B4 6NH","United Kingdom","UK",{"type":119,"coordinates":703},[704,705],-1.89983,52.48142,{"lat":705,"lon":704},[708],{"name":126,"role":106,"phone":709,"phoneExt":51,"email":51},"+441213338504",{"facility":711,"status":112,"city":712,"state":51,"zip":713,"country":700,"countryCode":701,"cosmosGeoPoint":714,"geoPoint":718,"contacts":719},"Sheffield Childrens Hospital ( Site 1503)","Sheffield","S10 2TH",{"type":119,"coordinates":715},[716,717],-1.4659,53.38297,{"lat":717,"lon":716},[720],{"name":126,"role":106,"phone":721,"phoneExt":51,"email":51},"+441142717000",{"facility":723,"status":112,"city":724,"state":51,"zip":725,"country":700,"countryCode":701,"cosmosGeoPoint":726,"geoPoint":730,"contacts":731},"Southampton General Hospital ( Site 1502)","Southampton","SO16 6YD",{"type":119,"coordinates":727},[728,729],-1.40428,50.90395,{"lat":729,"lon":728},[732],{"name":126,"role":106,"phone":733,"phoneExt":51,"email":51},"+442381204989",{"type":735,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100597406","a-study-of-enlicitide-decanoate-mk-0616-an-oral-pcsk9-inhibitor-in-children-and-adolescents-with-heterozygous-familial-hypercholesterolemia-mk-0616-029-100597406",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":747,"type":748},153,"ESTIMATED","INTERVENTIONAL",[751,752],"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.",[755],"Heterozygous Familial Hypercholesterolemia (HeFH)","2026-10-06",{"date":758,"type":759},"2026-10-07","ACTUAL",{"date":761,"type":759},"2025-08-21",{"date":763,"type":748},"2037-01-23",{"name":5,"class":6},47]