NCT07216482Active, not recruitingPhase 3
A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
Researchers designed a study medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C). In this study, researchers want to learn about giving enlicitide with another medicine called rosuvastatin. Rosuvastatin is a standard (usual) treatment to lower LDL-C. The goal of this study is to learn if enlicitide given with rosuvastatin works better than placebo on lowering LDL-C in a person's blood. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 996 (actual)
- First submitted
- 10 Oct 2025
- Start date
- 11 Nov 2025
- Primary completion date
- 3 Aug 2026
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07216482
- EU CT number
- 2025-521495-54-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 996
- From 11 Nov 2025 to the primary completion date, 3 Aug 2026
- 87 sites in 11 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
- Had a heart failure hospitalization within 3 months before Screening.
- Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Screening or plans to initiate an LDL-C apheresis program.
- Has received any medication that may interact with rosuvastatin within 5 half-lives prior to Screening or is planning to initiate such treatment.
Other illness
- Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
- Is unwilling to take a statin, and/or has a history of statin-associated muscle symptoms or other statin-related AEs to any statin and dose, and/or is known to be intolerant to 1 or more statins.
- Has a history of any of the following conditions: (1) Myopathy, myositis, rhabdomyolysis, or unexplained muscle pain; (2) Muscular or neuromuscular disease; (3) Neuropathy, fibromyalgia, or chronic pain; or (4) Has a personal or family history of hereditary muscular disorders.
- Has active or chronic hepatobiliary or hepatic disease.
- Has known human immunodeficiency virus (HIV) infection.
Who the study is looking for
- -Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (87)
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 0200) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| CEMEDIC ( Site 0201) Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206) Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205) Coordinator of this site? Confirm its status | Corrientes | Argentina | Unknown status |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Rosario ( Site 0204) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Fundacion Estudios Clinicos ( Site 0203) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Emeritus Research ( Site 0904) Coordinator of this site? Confirm its status | Camberwell | Australia | Unknown status |
| Baker - HeartWest ( Site 0902) Coordinator of this site? Confirm its status | Hoppers Crossing | Australia | Unknown status |
| Australian Clinical Research Network ( Site 0900) Coordinator of this site? Confirm its status | Maroubra | Australia | Unknown status |
| Fusion Clinical Research ( Site 0901) Coordinator of this site? Confirm its status | Norwood | Australia | Unknown status |
| Momentum Darlinghurst ( Site 0906) Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Momentum Clinical Research Taringa ( Site 0907) Coordinator of this site? Confirm its status | Taringa | Australia | Unknown status |
| Centro de Pesquisa Clinica do Coracao ( Site 0303) Coordinator of this site? Confirm its status | Aracaju | Brazil | Unknown status |
| Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305) Coordinator of this site? Confirm its status | Bragança Paulista | Brazil | Unknown status |
| Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306) Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309) Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Milestone Research Inc. ( Site 0111) Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Centricity Research Mirabel Multispecialty ( Site 0107) Coordinator of this site? Confirm its status | Mirabel | Canada | Unknown status |
| G A Research Associates ( Site 0102) Coordinator of this site? Confirm its status | Moncton | Canada | Unknown status |
| North York Diagnostic and Cardiac Centre ( Site 0110) Coordinator of this site? Confirm its status | North York | Canada | Unknown status |
| Recherche Clinique Sigma Inc ( Site 0108) Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Care Access - Thunder Bay ( Site 0130) Coordinator of this site? Confirm its status | Thunder Bay | Canada | Unknown status |
| EBA Centelles ( Site 0600) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| EAP Sardenya ( Site 0601) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Centro de Salud Concepcion Arenal ( Site 0603) Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Velocity Clinical Research Romford ( Site 0803) Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Lakeside Surgery ( Site 0802) Coordinator of this site? Confirm its status | Corby | United Kingdom | Unknown status |
| William Harvey Heart Centre ( Site 0800) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Velocity Clinical Research Havering ( Site 0804) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| West Walk Surgery ( Site 0801) Coordinator of this site? Confirm its status | Yate | United Kingdom | Unknown status |
| Lausmed Egészségügyi Szolgáltató ( Site 1105) Coordinator of this site? Confirm its status | Baja | Hungary | Unknown status |
| DRC Gyógyszervizsgáló Központ ( Site 1109) Coordinator of this site? Confirm its status | Balatonfüred | Hungary | Unknown status |
| Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102) Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Borbánya Praxis ( Site 1103) Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Unknown status |
| Barzilai Medical Center ( Site 0504) Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| Linn Medical Center ( Site 0503) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Care Campus ( Site 0500) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Meir Medical Center. ( Site 0501) Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Clalit Health Services - Sakhnin Community Clinic ( Site 0502) Coordinator of this site? Confirm its status | Sakhnin | Israel | Unknown status |
| Pacific Clinical Research Network - Forte ( Site 1004) Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Lakeland Clinical Trials Waikato ( Site 1000) Coordinator of this site? Confirm its status | Nawton | New Zealand | Unknown status |
| Pacific Clinical Research Network - Tasman ( Site 1003) Coordinator of this site? Confirm its status | Nelson | New Zealand | Unknown status |
| Pacific Clinical Research Network - Rotorua ( Site 1001) Coordinator of this site? Confirm its status | Rotorua | New Zealand | Unknown status |
| Lakeland Clinical Trials Wellington ( Site 1002) Coordinator of this site? Confirm its status | Upper Hutt | New Zealand | Unknown status |
| New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027) Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Conquest Research ( Site 0045) Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Central Research Associates ( Site 0009) Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Trialmed ( Site 0026) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Great Lakes Clinical Trials - Ravenswood ( Site 0018) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Legacy Clinical Trials ( Site 0044) Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Cardiovascular Associates of the Delaware Valley ( Site 0035) Coordinator of this site? Confirm its status | Elmer | United States | Unknown status |
| G&L Research ( Site 0024) Coordinator of this site? Confirm its status | Foley | United States | Unknown status |
| Alliance for Multispecialty Research, LLC ( Site 0040) Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Soffer Health Institute ( Site 0046) Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Provecta Research Network LLC ( Site 0022) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Midwest Institute For Clinical Research ( Site 0033) Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| East Coast Institute for Research ( Site 0041) Coordinator of this site? Confirm its status | Lake City | United States | Unknown status |
| Chemidox Clinical Trials ( Site 0008) Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Jubilee Clinical Research ( Site 0031) Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| L-MARC Research Center ( Site 0004) Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Manassas Clinical Research Center ( Site 0002) Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Inpatient Research Clinic ( Site 0017) Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Health Research of Hampton Roads, Inc. ( Site 0013) Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Alliance for Multispecialty Research, LLC ( Site 0048) Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Alliance for Multispecialty Research, LLC - Norman ( Site 0043) Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| Permian Research Foundation ( Site 0005) Coordinator of this site? Confirm its status | Odessa | United States | Unknown status |
| LinQ Research ( Site 0025) Coordinator of this site? Confirm its status | Pearland | United States | Unknown status |
| Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Rainier Clinical Research ( Site 0023) Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| National Clinical Research, Inc ( Site 0028) Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Clinical Trials Research ( Site 0036) Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021) Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Clinical Trials of Texas, Inc. ( Site 0010) Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Clinical Research Trials of Florida ( Site 0001) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Alliance for Multispecialty Research LLC ( Site 0049) Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
| LinQ Research - Tomball ( Site 0047) Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| Cotton O'Neil Clinical Research Center ( Site 0006) Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Clinical Site Partners LLC, dba CSP Orlando ( Site 0014) Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
| Cardiology Consultants of Philadelphia Yardley ( Site 0016) Coordinator of this site? Confirm its status | Yardley | United States | Unknown status |
| Ufuk University Dr.Ridvan Ege Hospital ( Site 0709) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Eskisehir Osmangazi University ( Site 0705) Coordinator of this site? Confirm its status | Eskişehir | Turkey (Türkiye) | Unknown status |
| Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701) Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702) Coordinator of this site? Confirm its status | Malatya | Turkey (Türkiye) | Unknown status |
| Hacettepe Universite Hastaneleri ( Site 0700) Coordinator of this site? Confirm its status | Sıhhiye | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.