Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-29 @ 6:02 PM
Study NCT ID:
NCT06450366
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000728674', 'term': 'MK-0616'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'C581236', 'term': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change from Baseline in LDL-C at Day 56', 'timeFrame': 'Baseline and Day 56', 'description': 'Blood samples will be collected at baseline and after 56 days of treatment to assess mean percentage change in LDL-C. The percent change from baseline in LDL-C at Day-56 will be reported.'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Day 56', 'timeFrame': 'Baseline and Day 56', 'description': 'Blood samples will be collected at baseline and on day 56 of treatment to assess mean percent change in ApoB. The percent change from baseline in ApoB at Day 56 will be reported.'}, {'measure': 'Mean Percent Change from Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Day 56', 'timeFrame': 'Baseline and Day 56', 'description': 'Blood samples will be collected at baseline and on day 56 of treatment to assess mean percent change in non-HDL-C. The percent change from baseline in non-HDL-C at 56 days will be reported.'}, {'measure': 'Percent Change from Baseline in Lipoprotein(a) Levels (Lp[a])', 'timeFrame': 'Baseline and Day 56', 'description': 'Blood samples will be collected at baseline and on day 56 of treatment to assess percent change in Lp(a) levels. The change from baseline at Day 56 will be reported.'}, {'measure': 'Percentage of Participants Who at Day 56 Have an LDL-C <70 mg/dL and ≥50% Reduction from Baseline', 'timeFrame': 'Baseline and Day 56', 'description': 'The percentage of participants who have an LDL-C \\<70 mg/dL and \\>50% reduction from baseline at day 56 will be reported.'}, {'measure': 'Percentage of Participants Who at Day 56 Have an LDL-C <55 mg/dL and ≥50% Reduction from Baseline', 'timeFrame': 'Baseline and Day 56', 'description': 'The percentage of participants who have an LDL-C \\<55 mg/dL and \\>50% reduction from baseline at day 56 will be reported.'}, {'measure': 'Number of Participants With ≥1 Adverse Event (AE)', 'timeFrame': 'Up to Approximately 112 days', 'description': 'An AE was 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. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.'}, {'measure': 'Number of Participants Discontinuing from Study Therapy Due to AE', 'timeFrame': 'Up to Approximately 56 days', 'description': 'An AE was 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. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26302&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess whether enlicitide decanoate is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing LDL-C in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide decanoate is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event\n* Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C ≥55 mg/dL (≥1.42 mmol/L) OR b) No history of a major ASCVD event with LDL-C ≥70 mg/dL (≥1.81 mmol/L)\n* Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy \\[LLT\\])\n* Is on a stable dose of all background LLTs with no planned medication or dose changes during the study\n* Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent\n\nExclusion Criteria:\n\n* Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH\n* Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction ≤25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening)\n* Participants with a history of tendon disorder or tendon rupture\n* Participants with a history of gout\n* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program\n* Was previously treated/is being treated with certain other cholesterol lowering medications, including ezetimibe, bempedoic acid, or protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout'}, 'identificationModule': {'nctId': 'NCT06450366', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia', 'orgStudyIdInfo': {'id': '0616-018'}, 'secondaryIdInfos': [{'id': 'MK-0616-018', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2023-504920-25', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1290-3888', 'type': 'REGISTRY', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enlicitide Decanoate', 'description': 'Participants receive enlicitide decanoate 20mg, ezetimibe-matching placebo, and bempedoic acid-matching placebo once daily (QD) orally up to approximately 56 days.', 'interventionNames': ['Drug: Enlicitide Decanoate', 'Other: Placebo for Ezetimibe', 'Other: Placebo for Bempedoic Acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ezetimibe', 'description': 'Participants receive ezetimibe 10mg, enlicitide decanoate-matching placebo, and bempedoic acid-matching placebo QD orally up to approximately 56 days.', 'interventionNames': ['Drug: Ezetimibe', 'Other: Placebo for Enlicitide Decanoate', 'Other: Placebo for Bempedoic Acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bempedoic Acid', 'description': 'Participants receive bempedoic acid 180mg, ezetimibe-matching placebo, and enlicitide decanoate-matching placebo QD orally up to approximately 56 days.', 'interventionNames': ['Drug: Bempedoic Acid', 'Other: Placebo for Enlicitide Decanoate', 'Other: Placebo for Ezetimibe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ezetimibe + Bempedoic Acid', 'description': 'Participants receive ezetimibe 10 mg, bempedoic acid 180mg, enlicitide decanoate-matching placebo orally QD for approximately 56 days.', 'interventionNames': ['Drug: Ezetimibe', 'Drug: Bempedoic Acid', 'Other: Placebo for Enlicitide Decanoate']}], 'interventions': [{'name': 'Enlicitide Decanoate', 'type': 'DRUG', 'otherNames': ['MK-0616'], 'description': 'Administered orally.', 'armGroupLabels': ['Enlicitide Decanoate']}, {'name': 'Ezetimibe', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Ezetimibe', 'Ezetimibe + Bempedoic Acid']}, {'name': 'Bempedoic Acid', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Bempedoic Acid', 'Ezetimibe + Bempedoic Acid']}, {'name': 'Placebo for Enlicitide Decanoate', 'type': 'OTHER', 'description': 'Administered orally.', 'armGroupLabels': ['Bempedoic Acid', 'Ezetimibe', 'Ezetimibe + Bempedoic Acid']}, {'name': 'Placebo for Ezetimibe', 'type': 'OTHER', 'description': 'Administered orally.', 'armGroupLabels': ['Bempedoic Acid', 'Enlicitide Decanoate']}, {'name': 'Placebo for Bempedoic Acid', 'type': 'OTHER', 'description': 'Administered orally.', 'armGroupLabels': ['Enlicitide Decanoate', 'Ezetimibe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research ( Site 1509)', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '60422', 'city': 'Flossmoor', 'state': 'Illinois', 'country': 'United States', 'facility': 'Healthcare Research Network - Chicago ( Site 1507)', 'geoPoint': {'lat': 41.54281, 'lon': -87.68477}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'L-MARC Research Center ( Site 1501)', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20854', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Velocity Clinical Research Rockville ( Site 1503)', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '39503', 'city': 'Gulfport', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Velocity Clinical Research, Gulfport ( Site 1505)', 'geoPoint': {'lat': 30.36742, 'lon': -89.09282}}, {'zip': '29707', 'city': 'Fort Mill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Piedmont Research Partners ( Site 1506)', 'geoPoint': {'lat': 35.00737, 'lon': -80.94508}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center ( Site 1502)', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': 'B7600FZO', 'city': 'Mar del Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002)', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': 'C1061AAS', 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