A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia, Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT05952856

Run by

Merck Sharp & Dohme LLC

People needed

2912

Starts

2023-08-10

Expected to finish

2025-07-28

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• G&L Research ( Site 0043) — Foley, Alabama, United States
• Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084) — Phoenix, Arizona, United States
• National Heart Institute-Research ( Site 0087) — Beverly Hills, California, United States
• Clinical Trials Research ( Site 0115) — Sacramento, California, United States
• Velocity Clinical Research, Banning ( Site 0017) — San Bernardino, California, United States
• Emerson Clinical Research Institute ( Site 0118) — Washington D.C., District of Columbia, United States
• Excel Medical Clinical Trials ( Site 0053) — Boca Raton, Florida, United States
• Alliance for Multispecialty Research, LLC ( Site 0088) — Coral Gables, Florida, United States
• Alliance for Multispecialty Research, LLC ( Site 0094) — Fort Myers, Florida, United States
• Velocity Clinical Research, Hallandale Beach ( Site 0018) — Hallandale, Florida, United States
• Jacksonville Center for Clinical Research ( Site 0049) — Jacksonville, Florida, United States
• South Broward Research ( Site 0051) — Miramar, Florida, United States
• Clinical Research Trials of Florida ( Site 0063) — Tampa, Florida, United States
• East Coast Institute for Research, LLC ( Site 0033) — Macon, Georgia, United States
• Healthcare Research Network - Chicago ( Site 0052) — Flossmoor, Illinois, United States
• Synexus Clinical Research US, Inc. ( Site 0109) — Evansville, Indiana, United States
• Midwest Institute For Clinical Research ( Site 0059) — Indianapolis, Indiana, United States
• Alliance for Multispecialty Research, LLC ( Site 0028) — Lexington, Kentucky, United States
• L-MARC Research Center ( Site 0001) — Louisville, Kentucky, United States
• Velocity Clinical Research, Covington ( Site 0068) — Covington, Louisiana, United States
• Velocity Clinical Research Rockville ( Site 0082) — Rockville, Maryland, United States
• Velocity Clinical Research, Gulfport ( Site 0039) — Gulfport, Mississippi, United States
• Healthcare Research Network - St. Louis ( Site 0054) — Hazelwood, Missouri, United States
• Jubilee Clinical Research ( Site 0106) — Las Vegas, Nevada, United States
• Alliance for Multispecialty Research, LLC ( Site 0093) — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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