A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)

NCT07216482 | Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: 0616-037U1111-1319-95022025-521495-54-00MK-0616-037
• Study Type: interventional
• Target: 975
• Locations: 11 countries
• Sites: 89

Brief Summary

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)

  Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C between participants treated with enlicitide and rosuvastatin versus placebo.

  Baseline and Week 8

Secondary Outcomes (9)

• Mean Percent Change from Baseline in LDL-C at Week 8

  Baseline and Week 8

• Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8

  Baseline and Week 8

• Number of Participants with One or More Adverse Events (AEs)

  Up to approximately 20 weeks

• Number of Participants who Discontinue Study Drug Due to One or More AEs

  Up to approximately 12 weeks

• Mean Percent Change from Baseline in LDL-C at Week 12

  Baseline and Week 12

Study Arms (4)

Enlicitide

EXPERIMENTAL

Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.

Drug: Enlicitide; Drug: Placebo for Rosuvastatin

Enlicitide + Rosuvastatin

EXPERIMENTAL

Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.

Drug: Enlicitide; Drug: Rosuvastatin

Rosuvastatin

ACTIVE COMPARATOR

Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.

Drug: Rosuvastatin; Drug: Placebo for Enlicitide

Placebo

PLACEBO COMPARATOR

Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.

Drug: Placebo for Enlicitide; Drug: Placebo for Rosuvastatin

Interventions

Enlicitide DRUG

Oral Tablet

Also known as: MK-0616, Enlicitide decanoate

Enlicitide; Enlicitide + Rosuvastatin

Placebo for Enlicitide DRUG

Oral Tablet

Placebo; Rosuvastatin

Rosuvastatin DRUG

Oral Capsule

Enlicitide + Rosuvastatin; Rosuvastatin

Placebo for Rosuvastatin DRUG

Oral Capsule

Enlicitide; Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.

You may not qualify if:

• Has a history of homozygous familial hypercholesterolemia (FH), compound heterozygous FH, or double heterozygous FH.
• Had a heart failure hospitalization within 3 months before Screening.
• 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.
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (89)

Central Research Associates ( Site 0009)

Birmingham, Alabama, 35205, United States

ACTIVE NOT RECRUITING

G&L Research ( Site 0024)

Foley, Alabama, 36535, United States

ACTIVE NOT RECRUITING

Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)

Phoenix, Arizona, 85020, United States

ACTIVE NOT RECRUITING

Alliance for Multispecialty Research LLC ( Site 0049)

Tempe, Arizona, 85281, United States

ACTIVE NOT RECRUITING

Chemidox Clinical Trials ( Site 0008)

Lancaster, California, 93534, United States

ACTIVE NOT RECRUITING

Clinical Trials Research ( Site 0036)

Sacramento, California, 95821, United States

ACTIVE NOT RECRUITING

Legacy Clinical Trials ( Site 0044)

Colorado Springs, Colorado, 80909, United States

ACTIVE NOT RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0040)

Fort Myers, Florida, 33912, United States

ACTIVE NOT RECRUITING

Soffer Health Institute ( Site 0046)

Hollywood, Florida, 33020, United States

ACTIVE NOT RECRUITING

East Coast Institute for Research ( Site 0041)

Lake City, Florida, 32055, United States

ACTIVE NOT RECRUITING

Inpatient Research Clinic ( Site 0017)

Miami Lakes, Florida, 33014, United States

ACTIVE NOT RECRUITING

Clinical Research Trials of Florida ( Site 0001)

Tampa, Florida, 33607, United States

ACTIVE NOT RECRUITING

Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)

Winter Park, Florida, 32789, United States

ACTIVE NOT RECRUITING

Trialmed ( Site 0026)

Chicago, Illinois, 60602, United States

ACTIVE NOT RECRUITING

Great Lakes Clinical Trials - Ravenswood ( Site 0018)

Chicago, Illinois, 60640, United States

ACTIVE NOT RECRUITING

Midwest Institute For Clinical Research ( Site 0033)

Indianapolis, Indiana, 46260-5310, United States

ACTIVE NOT RECRUITING

Alliance for Multispecialty Research, LLC ( Site 0048)

Newton, Kansas, 67114, United States

ACTIVE NOT RECRUITING

Cotton O'Neil Clinical Research Center ( Site 0006)

Topeka, Kansas, 66606, United States

ACTIVE NOT RECRUITING

Monroe Biomedical Research ( Site 0004)

Louisville, Kentucky, 40213, United States

ACTIVE NOT RECRUITING

Jubilee Clinical Research ( Site 0031)

Las Vegas, Nevada, 89106, United States

ACTIVE NOT RECRUITING

Cardiovascular Associates of the Delaware Valley ( Site 0035)

Elmer, New Jersey, 08318, United States

ACTIVE NOT RECRUITING

New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)

Albuquerque, New Mexico, 87106-4725, United States

ACTIVE NOT RECRUITING

Alliance for Multispecialty Research, LLC - Norman ( Site 0043)

Norman, Oklahoma, 73069, United States

ACTIVE NOT RECRUITING

Cardiology Consultants of Philadelphia Yardley ( Site 0016)

Yardley, Pennsylvania, 19067, United States

ACTIVE NOT RECRUITING

Provecta Research Network LLC ( Site 0022)

Houston, Texas, 77027, United States

RECRUITING

Permian Research Foundation ( Site 0005)

Odessa, Texas, 79761, United States

ACTIVE NOT RECRUITING

LinQ Research ( Site 0025)

Pearland, Texas, 77584, United States

ACTIVE NOT RECRUITING

Clinical Trials of Texas, Inc. ( Site 0010)

San Antonio, Texas, 78229, United States

RECRUITING

Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)

San Antonio, Texas, 78258, United States

ACTIVE NOT RECRUITING

LinQ Research - Tomball ( Site 0047)

Tomball, Texas, 77375, United States

ACTIVE NOT RECRUITING

Manassas Clinical Research Center ( Site 0002)

Manassas, Virginia, 20110, United States

ACTIVE NOT RECRUITING

Health Research of Hampton Roads, Inc. ( Site 0013)

Newport News, Virginia, 23606, United States

ACTIVE NOT RECRUITING

National Clinical Research, Inc ( Site 0028)

Richmond, Virginia, 23294, United States

ACTIVE NOT RECRUITING

Conquest Research ( Site 0045)

Vienna, Virginia, 22182, United States

ACTIVE NOT RECRUITING

Rainier Clinical Research ( Site 0023)

Renton, Washington, 98057, United States

ACTIVE NOT RECRUITING

CEMEDIC ( Site 0201)

CABA, Buenos Aires, C1407GTL, Argentina

ACTIVE NOT RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

ACTIVE NOT RECRUITING

CIPREC-CIPREC Sede Arenales ( Site 0200)

Buenos Aires, Buenos Aires F.D., C1061AAS, Argentina

ACTIVE NOT RECRUITING

Fundacion Estudios Clinicos ( Site 0203)

Rosario, Santa Fe Province, S2000CVD, Argentina

ACTIVE NOT RECRUITING

Instituto de Investigaciones Clinicas Rosario ( Site 0204)

Rosario, Santa Fe Province, S2000CVD, Argentina

ACTIVE NOT RECRUITING

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)

CABA, C1425AGC, Argentina

ACTIVE NOT RECRUITING

Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205)

Corrientes, W3400AMZ, Argentina

ACTIVE NOT RECRUITING

Australian Clinical Research Network ( Site 0900)

Maroubra, New South Wales, 2035, Australia

ACTIVE NOT RECRUITING

Momentum Darlinghurst ( Site 0906)

Sydney, New South Wales, 2010, Australia

ACTIVE NOT RECRUITING

Momentum Clinical Research Taringa ( Site 0907)

Taringa, Queensland, 4068, Australia

ACTIVE NOT RECRUITING

Fusion Clinical Research ( Site 0901)

Norwood, South Australia, 5067, Australia

ACTIVE NOT RECRUITING

Emeritus Research ( Site 0904)

Camberwell, Victoria, 3124, Australia

ACTIVE NOT RECRUITING

Baker - HeartWest ( Site 0902)

Hoppers Crossing, Victoria, 3029, Australia

ACTIVE NOT RECRUITING

Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)

Fortaleza, Ceará, 60430-350, Brazil

RECRUITING

Centro de Pesquisa Clinica do Coracao ( Site 0303)

Aracaju, Sergipe, 49055-530, Brazil

RECRUITING

Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)

Bragança Paulista, São Paulo, 12916-542, Brazil

ACTIVE NOT RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)

Rio de Janeiro, 20241-180, Brazil

RECRUITING

G A Research Associates ( Site 0102)

Moncton, New Brunswick, E1G 1A7, Canada

ACTIVE NOT RECRUITING

Milestone Research Inc. ( Site 0111)

London, Ontario, N5W 6A2, Canada

ACTIVE NOT RECRUITING

North York Diagnostic and Cardiac Centre ( Site 0110)

North York, Ontario, M6B 3H7, Canada

RECRUITING

Care Access - Thunder Bay ( Site 0130)

Thunder Bay, Ontario, P7B 7C7, Canada

RECRUITING

Centricity Research Mirabel Multispecialty ( Site 0107)

Mirabel, Quebec, J7J 2K8, Canada

ACTIVE NOT RECRUITING

Institut de Cardiologie de Montreal ( Site 0109)

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Recherche Clinique Sigma Inc ( Site 0108)

Québec, Quebec, G1G 5X1, Canada

ACTIVE NOT RECRUITING

Lausmed Egészségügyi Szolgáltató ( Site 1105)

Baja, Bács-Kiskun county, 6500, Hungary

ACTIVE NOT RECRUITING

Borbánya Praxis ( Site 1103)

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4405, Hungary

ACTIVE NOT RECRUITING

DRC Gyógyszervizsgáló Központ ( Site 1109)

Balatonfüred, Veszprém megye, 8230, Hungary

ACTIVE NOT RECRUITING

Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)

Debrecen, 4032, Hungary

ACTIVE NOT RECRUITING

Barzilai Medical Center ( Site 0504)

Ashkelon, 7830604, Israel

ACTIVE NOT RECRUITING

Linn Medical Center ( Site 0503)

Haifa, 3100000, Israel

ACTIVE NOT RECRUITING

Rambam Health Care Campus ( Site 0500)

Haifa, 3109601, Israel

ACTIVE NOT RECRUITING

Meir Medical Center. ( Site 0501)

Kfar Saba, 4428164, Israel

ACTIVE NOT RECRUITING

Clalit Health Services - Sakhnin Community Clinic ( Site 0502)

Sakhnin, 3081000, Israel

ACTIVE NOT RECRUITING

Pacific Clinical Research Network - Rotorua ( Site 1001)

Rotorua, Bay of Plenty, 3010, New Zealand

ACTIVE NOT RECRUITING

Pacific Clinical Research Network - Forte ( Site 1004)

Christchurch, Canterbury, 8013, New Zealand

ACTIVE NOT RECRUITING

Pacific Clinical Research Network - Tasman ( Site 1003)

Nelson, Tasman District, 7011, New Zealand

ACTIVE NOT RECRUITING

Lakeland Clinical Trials Waikato ( Site 1000)

Nawton, Waikato Region, 3200, New Zealand

ACTIVE NOT RECRUITING

Lakeland Clinical Trials Wellington ( Site 1002)

Upper Hutt, Wellington Region, 5018, New Zealand

ACTIVE NOT RECRUITING

Centro de Salud Concepcion Arenal ( Site 0603)

Santiago de Compostela, Galicia, 15701, Spain

ACTIVE NOT RECRUITING

EAP Sardenya ( Site 0601)

Barcelona, 08025, Spain

ACTIVE NOT RECRUITING

EBA Centelles ( Site 0600)

Barcelona, 08540, Spain

ACTIVE NOT RECRUITING

Hacettepe Universite Hastaneleri ( Site 0700)

Sıhhiye, Ankara, 06230, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)

Ankara, 06520, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Eskisehir Osmangazi University ( Site 0705)

Eskişehir, 26480, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)

Istanbul, 34080, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Ege Universitesi Hastanesi ( Site 0708)

Izmir, 35080, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)

Kayseri, 38030, Turkey (Türkiye)

ACTIVE NOT RECRUITING

İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)

Malatya, 44280, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Velocity Clinical Research, Bristol ( Site 0803)

Bristol, Bristol, City of, BS8 2RA, United Kingdom

ACTIVE NOT RECRUITING

West Walk Surgery ( Site 0801)

Yate, Gloucestershire, BS37 4AX, United Kingdom

ACTIVE NOT RECRUITING

Velocity Clinical Research Havering ( Site 0804)

London, Havering, RM1 3PJ, United Kingdom

ACTIVE NOT RECRUITING

William Harvey Heart Centre ( Site 0800)

London, London, City of, EC1M 6BQ, United Kingdom

ACTIVE NOT RECRUITING

Lakeside Surgery ( Site 0802)

Corby, Northamptonshire, NN17 2UR, United Kingdom

ACTIVE NOT RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Hyperlipidemias

Interventions

MK-0616; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 14, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

NZ (5); TU (7); CA (7); GB (5); IL (5); AR (7); ES (3); AU (6); US (35); BR (5); HU (4)