NCT06450366CompletedPhase 3
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)
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 301 (actual)
- First submitted
- 4 Jun 2024
- Start date
- 8 Jul 2024
- Primary completion date
- 14 Feb 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06450366
- EU CT number
- 2023-504920-25-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 301
- From 8 Jul 2024 to the primary completion date, 14 Feb 2025
- 35 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH
- Participants with a history of tendon disorder or tendon rupture
- Participants with a history of gout
Lab values
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CIPREC-CIPREC Sede Arenales ( Site 1000) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Fundacion Estudios Clinicos ( Site 1001) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Cambridge Cardiac Care Centre ( Site 1603) Coordinator of this site? Confirm its status | Cambridge | Canada | Unknown status |
| Institut de Cardiologie de Montreal ( Site 1604) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| North York Diagnostic and Cardiac Centre ( Site 1605) Coordinator of this site? Confirm its status | North York | Canada | Unknown status |
| Diex Recherche Trois-Rivieres ( Site 1602) Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| The Medical Arts Health Research Group ( Site 1606) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Instituto Medico Quirurgico San Rafael S.A. Coordinator of this site? Confirm its status | A Coruna | Spain | Completed |
| Equip D'atencio Primaria Barcelona Sardenya S.L.P. Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Fundacio Salut Emporda Coordinator of this site? Confirm its status | Figueres | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Completed |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | St Herblain | France | Completed |
| National Institute for Health Research UCLH Clinical Research Facility ( Site 0908) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 0901) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Free Hospital ( Site 0900) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Assuta Beersheba MC ( Site 0704) Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Yitzhak Shamir Medical Center. ( Site 0702) Coordinator of this site? Confirm its status | Beer Yaakov | Israel | Unknown status |
| Rambam Health Care Campus ( Site 0700) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Meir Medical Center. ( Site 0703) Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| National Cheng Kung University Hospital-Internal Medicine ( Site 0403) Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital-Department of Medicine ( Site 0402) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital ( Site 0400) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation-Linkou Branch ( Site 0404) Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Healthcare Research Network - Chicago ( Site 1507) Coordinator of this site? Confirm its status | Flossmoor | United States | Unknown status |
| Piedmont Research Partners ( Site 1506) Coordinator of this site? Confirm its status | Fort Mill | United States | Unknown status |
| Velocity Clinical Research, Gulfport ( Site 1505) Coordinator of this site? Confirm its status | Gulfport | United States | Unknown status |
| Clinical Trials Research ( Site 1509) Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| L-MARC Research Center ( Site 1501) Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Rainier Clinical Research Center ( Site 1502) Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| Velocity Clinical Research Rockville ( Site 1503) Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.