> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-enlicitide-decanoate-mk-0616-oral-pcsk9-inhibitor-c11b7289-b11a-4030-88aa-64eb004a2bb0 > Record changed: 2026-10-13 # A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids NCT05952856 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) Participants 2,912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) Start date 2023-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) Number of sites 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Title and summary **Summary** The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Short title** A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Official title** A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Dates **Completion date** 2025-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **First posted** 2023-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Registry last updated** 2026-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Primary completion date** 2025-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Start date** 2023-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Size and sites **Actual participants** 2,912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Participants** 2,912 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Number of sites** 168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Identifiers **Registry ID** NCT05952856 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **ClinicalTrials.gov ID** NCT05952856 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Outcomes ### Primary outcomes 1. Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 Timeframe: Baseline and Week 24 Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C. 2. Number of Participants With One or More Adverse Events (AEs) Timeframe: Up to 60 weeks 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. 3. Number of Participants Who Discontinued Study Drug Due to an AE Timeframe: Up to 52 weeks 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. ### Secondary outcomes 1. Mean Percent Change From Baseline in LDL-C at Week 52 Timeframe: Baseline and Week 52 Blood samples collected at baseline and Week 52 were used to assess mean percent change in LDL-C. 2. Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 Timeframe: Baseline and Week 24 Blood samples collected at baseline and Week 24 were used to assess mean percent change in non-HDL-C. 3. Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 Timeframe: Baseline and Week 24 Blood samples collected at baseline and Week 24 were used to assess mean percent change in ApoB. 4. Percent Change From Baseline in Lipoprotein(a) (Lp(a)) at Week 24 Timeframe: Baseline and Week 24 Blood samples collected at baseline and Week 24 were used to assess percent change in Lp(a). 5. Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24 Timeframe: Baseline and Week 24 Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C \\<70 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal. 6. Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24 Timeframe: Baseline and Week 24 Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C \\<55 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL. - 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 - If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change. ### Exclusion criteria - Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH - Has a history of heart failure or heart failure hospitalization within 3 months before first study visit - 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 - Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Sites - Alliance for Multispecialty Research, LLC ( Site 0093)Daphne, United States - G&L Research ( Site 0043)Foley, United States - Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)Phoenix, United States - National Heart Institute-Research ( Site 0087)Beverly Hills, United States - Clinical Trials Research ( Site 0115)Sacramento, United States - Velocity Clinical Research, Banning ( Site 0017)San Bernardino, United States - Emerson Clinical Research Institute ( Site 0118)Washington D.C., United States - Excel Medical Clinical Trials ( Site 0053)Boca Raton, United States - Alliance for Multispecialty Research, LLC ( Site 0088)Coral Gables, United States - Alliance for Multispecialty Research, LLC ( Site 0094)Fort Myers, United States - Velocity Clinical Research, Hallandale Beach ( Site 0018)Hallandale, United States - Jacksonville Center for Clinical Research ( Site 0049)Jacksonville, United States - South Broward Research ( Site 0051)Miramar, United States - Clinical Research Trials of Florida ( Site 0063)Tampa, United States - East Coast Institute for Research, LLC ( Site 0033)Macon, United States - Healthcare Research Network - Chicago ( Site 0052)Flossmoor, United States - Synexus Clinical Research US, Inc. ( Site 0109)Evansville, United States - Midwest Institute For Clinical Research ( Site 0059)Indianapolis, United States - Alliance for Multispecialty Research, LLC ( Site 0028)Lexington, United States - L-MARC Research Center ( Site 0001)Louisville, United States - Velocity Clinical Research, Covington ( Site 0068)Covington, United States - Velocity Clinical Research Rockville ( Site 0082)Rockville, United States - Velocity Clinical Research, Gulfport ( Site 0039)Gulfport, United States - Healthcare Research Network - St. Louis ( Site 0054)Hazelwood, United States - Jubilee Clinical Research ( Site 0106)Las Vegas, United States And 143 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## References - PubMed 41879224 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41879224/) Related publication - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](http://www.merckclinicaltrials.com/) ### Other registry identifiers (4) - MK-0616-013 - U1111-1285-4164 - 2022-502777-42-00 - jRCT2031230320 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952856) ## Related records ### Drugs (1) - [Enlicitide decanoate](https://trialight.com/data/asset/enlicitide-decanoate-3671a2dd-56b6-4033-acf5-27fbb0102d79.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (2) - [Familial hypercholesterolemia](https://trialight.com/data/condition/familial-hypercholesterolemia-ee6bd6b4-71cd-509a-9360-eb8a7c2bd428.md) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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