Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05952869
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2023-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000728674', 'term': 'MK-0616'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.'}, {'measure': 'Number of participants with one or more adverse events (AEs)', 'timeFrame': 'Up to ~60 weeks', 'description': '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.'}, {'measure': 'Number of participants who discontinue study drug due to an AE', 'timeFrame': 'Up to ~52 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean percent change from baseline in LDL-C at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': 'Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.'}, {'measure': 'Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.'}, {'measure': 'Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.'}, {'measure': 'Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).'}, {'measure': 'Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \\<70 mg/dL and ≥50% reduction from baseline.'}, {'measure': 'Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \\<55 mg/dL and ≥50% reduction from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia', 'Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '41206969', 'type': 'DERIVED', 'citation': 'Ballantyne CM, Gellis L, Tardif JC, Banka P, Navar AM, Asprusten EA, Scott R, Stroes ESG, Froman S, Mendizabal G, Wang F, Catapano AL. Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial. JAMA. 2025 Nov 9:e2520620. doi: 10.1001/jama.2025.20620. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26188&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm\n* Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history\n* Is treated with a moderate- or high-intensity statin medication\n* Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change\n\nExclusion Criteria:\n\n* Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH\n* Has a history of heart failure or heart failure hospitalization within 3 months before first study visit\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/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors'}, 'identificationModule': {'nctId': 'NCT05952869', 'briefTitle': 'A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': '0616-017'}, 'secondaryIdInfos': [{'id': 'MK-0616-017', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2022-502782-14-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1285-4257', 'type': 'REGISTRY', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enlicitide Decanoate', 'description': 'Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.', 'interventionNames': ['Drug: Enlicitide Decanoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Enlicitide Decanoate', 'type': 'DRUG', 'otherNames': ['MK-0616'], 'description': 'Oral tablet', 'armGroupLabels': ['Enlicitide Decanoate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36526', 'city': 'Daphne', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC ( Site 0023)', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Excel Medical Clinical Trials ( Site 0008)', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33189', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Pharma Research ( Site 0007)', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Progressive Medical Research ( Site 0021)', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Synexus Clinical Research US - 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