A Study to Evaluate the Efficacy and Safety of Enlicitide (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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.
Key facts
- Study ID
- NCT06450366
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 301
- Starts
- 2024-07-08
- Expected to finish
- 2025-03-28
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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 low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL (≥1.81 mmol/L)
- Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy [LLT])
- Is on a stable dose of all background LLTs with no planned medication or dose changes during the study
- Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent
You may not qualify if…
- Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH
- 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)
- Participants with a history of tendon disorder or tendon rupture
- Participants with a history of gout
- 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
- 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
Where it is running
- Clinical Trials Research ( Site 1509) — Lincoln, California, United States
- Healthcare Research Network - Chicago ( Site 1507) — Flossmoor, Illinois, United States
- L-MARC Research Center ( Site 1501) — Louisville, Kentucky, United States
- Velocity Clinical Research Rockville ( Site 1503) — Rockville, Maryland, United States
- Velocity Clinical Research, Gulfport ( Site 1505) — Gulfport, Mississippi, United States
- Piedmont Research Partners ( Site 1506) — Fort Mill, South Carolina, United States
- Rainier Clinical Research Center ( Site 1502) — Renton, Washington, United States
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002) — Mar del Plata, Buenos Aires, Argentina
- CIPREC-CIPREC Sede Arenales ( Site 1000) — Buenos Aires, Buenos Aires F.D., Argentina
- Fundacion Estudios Clinicos ( Site 1001) — Rosario, Santa Fe Province, Argentina
- The Medical Arts Health Research Group ( Site 1606) — Vancouver, British Columbia, Canada
- Cambridge Cardiac Care Centre ( Site 1603) — Cambridge, Ontario, Canada
- North York Diagnostic and Cardiac Centre ( Site 1605) — North York, Ontario, Canada
- Institut de Cardiologie de Montreal ( Site 1604) — Montreal, Quebec, Canada
- Diex Recherche Trois-Rivieres ( Site 1602) — Trois-Rivières, Quebec, Canada
- Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 0505) — Montpellier, Herault, France
- Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-CIC Endocrinology-Diabetology-Nutrition ( Sit — Nantes, Loire-Atlantique, France
- Hospices Civils de Lyon - Hopital Louis Pradel ( Site 0501) — Bron, Rhone, France
- Hôpital Bichat - Claude-Bernard ( Site 0504) — Paris, France
- Yitzhak Shamir Medical Center. ( Site 0702) — Beer Yaakov, Israel
- Assuta Beersheba MC ( Site 0704) — Beersheba, Israel
- Rambam Health Care Campus ( Site 0700) — Haifa, Israel
- Meir Medical Center. ( Site 0703) — Kfar Saba, Israel
- Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 0801) — Málaga, Andalusia, Spain
- Hospital de Figueres ( Site 0804) — Figueres, Gerona, Spain
Full record on ClinicalTrials.gov
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