[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656293":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":47,"interventions":60,"overallOfficials":70,"centralContacts":36,"locations":36,"responsibleParty":74,"collaborators":36,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":36,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":36,"enrollmentInfo":85,"targetDuration":36,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":36,"overallStatus":95,"whyStopped":36,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":36},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":36},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24","Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.","Baseline and Week 24",{"measure":14,"description":15,"timeFrame":16},"Number of Participants with One or More Adverse Events (AEs)","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 32 Weeks",{"measure":18,"description":15,"timeFrame":19},"Number of Participants who Discontinue Study Drug Due to One or More AEs","Up to approximately 24 Weeks",[21,24,27,30,33],{"measure":22,"description":23,"timeFrame":12},"Mean Percent Change From Baseline in Non High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24","Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.",{"measure":25,"description":26,"timeFrame":12},"Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24","Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.",{"measure":28,"description":29,"timeFrame":12},"Percent Change From Baseline in Lipoprotein (a) (Lp(a)) at Week 24","Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a)",{"measure":31,"description":32,"timeFrame":12},"Percentage of Participants With LDL-C \u003C70 mg\u002FdL and ≥50% Reduction From Baseline at Week 24","Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \\\u003C70 mg\u002FdL and ≥50% reduction from baseline.",{"measure":34,"description":35,"timeFrame":12},"Percentage of Participants With LDL-C \u003C55 mg\u002FdL and ≥50% Reduction From Baseline at Week 24","Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \\\u003C55 mg\u002FdL and ≥50% reduction from baseline.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":43},"TRIPLE",[44,45,46],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Enlicitide Decanoate","EXPERIMENTAL","Participants will receive 20 mg enlicitide decanoate orally once daily (qd) for up to 24 weeks.",[53],"Drug: Enlicitide Decanoate",{"label":55,"type":56,"description":57,"interventionNames":58},"Placebo","OTHER","Participants will receive placebo orally qd for up to 24 weeks.",[59],"Other: Placebo",[61,68],{"type":62,"name":49,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Oral administration",[49],[66,67],"MK-0616","enlicitide",{"type":56,"name":55,"description":63,"armGroupLabels":69,"otherNames":36},[55],[71],{"name":72,"affiliation":5,"role":73},"Medical Director","STUDY_DIRECTOR",{"type":75,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100656293","phase-3-a-clinical-study-of-enlicitide-mk-0616-in-adults-with-hyperlipidemia-in-india-mk-0616-038-100656293",false,"NCT07821944","A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate in Adults With Hyperlipidemia in India","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), diabetes mellitus, stable angina pectoris, transient ischemic attack or symptomatic peripheral arterial disease\n* Has a low-density lipoprotein cholesterol (LDL-C) ≥55 mg\u002FdL or ≥70 mg\u002FdL depending on medical history\n* Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance\n* If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Had a heart failure hospitalization within 3 months before Screening\n* Has unstable angina, a myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening\n* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program\n* Was previously treated\u002Fis being treated with certain other cholesterol lowering medications, including protein convertase subtilisin\u002Fkexin type 9 (PCSK9) inhibitors\n* Has a history of nephrotic syndrome\n* Has poorly controlled diabetes mellitus\n* Has hyperthyroidism or inadequately controlled hypothyroidism\n* Is actively receiving chemotherapy for malignancy or has a history of malignancy ≤3 years before Screening","ALL","18 Years",{"count":86,"type":87},150,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood.\n\nEnlicitide (also known as enlicitide decanoate or MK-0616), the study medicine, is in a class of medicines designed to lower low-density lipoprotein cholesterol (LDL-C). LDL-C is sometimes called \"bad cholesterol.\"\n\nThe goal of this study is to learn if enlicitide works better than placebo to lower the amount of LDL-C in a person's blood. Researchers also want to learn about the safety of enlicitide and if people tolerate it.",[93,94],"Hyperlipidemia","Hypercholesterolemia","NOT_YET_RECRUITING","2026-09-09",{"date":98,"type":99},"2026-09-16","ACTUAL",{"date":101,"type":87},"2026-10-16",{"date":103,"type":87},"2027-11-26",{"name":5,"class":6}]