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HyperlipidemiaPhase 3NCT07216482

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

A Phase 3 study testing Enlicitide and Rosuvastatin in people with Hyperlipidemia, run by Merck Sharp & Dohme LLC at 87 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Hyperlipidemia
What is being tested?
Enlicitide and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
996 participants
Where
87 sitesin 11 countries
Study dates
11 Nov 2025to 5 Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

87 sites in 11 countries.

87 sites in 11 countries

United States35 sites

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

    Albuquerque, New Mexico, 87106-4725

  • Conquest Research ( Site 0045)

    Arlington, Virginia, 22205

  • Central Research Associates ( Site 0009)

    Birmingham, Alabama, 35205

  • Trialmed ( Site 0026)

    Chicago, Illinois, 60602

  • Great Lakes Clinical Trials - Ravenswood ( Site 0018)

    Chicago, Illinois, 60640

  • Legacy Clinical Trials ( Site 0044)

    Colorado Springs, Colorado, 80909

  • Cardiovascular Associates of the Delaware Valley ( Site 0035)

    Elmer, New Jersey, 08318

  • G&L Research ( Site 0024)

    Foley, Alabama, 36535

  • Alliance for Multispecialty Research, LLC ( Site 0040)

    Fort Myers, Florida, 33912

  • Soffer Health Institute ( Site 0046)

    Hollywood, Florida, 33020

  • Provecta Research Network LLC ( Site 0022)

    Houston, Texas, 77027

  • Midwest Institute For Clinical Research ( Site 0033)

    Indianapolis, Indiana, 46260-5310

  • East Coast Institute for Research ( Site 0041)

    Lake City, Florida, 32055

  • Chemidox Clinical Trials ( Site 0008)

    Lancaster, California, 93534

  • Jubilee Clinical Research ( Site 0031)

    Las Vegas, Nevada, 89106

  • L-MARC Research Center ( Site 0004)

    Louisville, Kentucky, 40213

  • Manassas Clinical Research Center ( Site 0002)

    Manassas, Virginia, 20110

  • Inpatient Research Clinic ( Site 0017)

    Miami Lakes, Florida, 33014

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

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research, LLC ( Site 0048)

    Newton, Kansas, 67114

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

    Norman, Oklahoma, 73069

  • Permian Research Foundation ( Site 0005)

    Odessa, Texas, 79761

  • LinQ Research ( Site 0025)

    Pearland, Texas, 77584

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

    Phoenix, Arizona, 85020

  • Rainier Clinical Research ( Site 0023)

    Renton, Washington, 98057

  • National Clinical Research, Inc ( Site 0028)

    Richmond, Virginia, 23294

  • Clinical Trials Research ( Site 0036)

    Sacramento, California, 95821

  • Clinical Trials of Texas, Inc. ( Site 0010)

    San Antonio, Texas, 78229

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

    San Antonio, Texas, 78258

  • Clinical Research Trials of Florida ( Site 0001)

    Tampa, Florida, 33607

  • Alliance for Multispecialty Research LLC ( Site 0049)

    Tempe, Arizona, 85281

  • LinQ Research - Tomball ( Site 0047)

    Tomball, Texas, 77375

  • Cotton O'Neil Clinical Research Center ( Site 0006)

    Topeka, Kansas, 66606

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

    Winter Park, Florida, 32789

  • Cardiology Consultants of Philadelphia Yardley ( Site 0016)

    Yardley, Pennsylvania, 19067

Other trials in United States

Argentina7 sites

  • CIPREC-CIPREC Sede Arenales ( Site 0200)

    Buenos Aires, Buenos Aires F.D., C1061AAS

  • CEMEDIC ( Site 0201)

    CABA, Buenos Aires, C1407GTL

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

    CABA, C1425AGC

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

    Corrientes, W3400AMZ

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)

    Mar del Plata, Buenos Aires, B7600FZO

  • Fundacion Estudios Clinicos ( Site 0203)

    Rosario, Santa Fe Province, S2000CVD

  • Instituto de Investigaciones Clinicas Rosario ( Site 0204)

    Rosario, Santa Fe Province, S2000CVD

Other trials in Argentina

Australia6 sites

  • Emeritus Research ( Site 0904)

    Camberwell, Victoria, 3124

  • Baker - HeartWest ( Site 0902)

    Hoppers Crossing, Victoria, 3029

  • Australian Clinical Research Network ( Site 0900)

    Maroubra, New South Wales, 2035

  • Fusion Clinical Research ( Site 0901)

    Norwood, South Australia, 5067

  • Momentum Darlinghurst ( Site 0906)

    Sydney, New South Wales, 2010

  • Momentum Clinical Research Taringa ( Site 0907)

    Taringa, Queensland, 4068

Other trials in Australia

Canada6 sites

  • Milestone Research Inc. ( Site 0111)

    London, Ontario, N5W 6A2

  • Centricity Research Mirabel Multispecialty ( Site 0107)

    Mirabel, Quebec, J7J 2K8

  • G A Research Associates ( Site 0102)

    Moncton, New Brunswick, E1G 1A7

  • North York Diagnostic and Cardiac Centre ( Site 0110)

    North York, Ontario, M6B 3H7

  • Recherche Clinique Sigma Inc ( Site 0108)

    Québec, Quebec, G1G 5X1

  • Care Access - Thunder Bay ( Site 0130)

    Thunder Bay, Ontario, P7B 7C7

Other trials in Canada

Turkey (Türkiye)6 sites

  • Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)

    Ankara, 06520

  • Eskisehir Osmangazi University ( Site 0705)

    Eskişehir, 26480

  • Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)

    Istanbul, 34080

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)

    Kayseri, 38030

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)

    Malatya, 44280

  • Hacettepe Universite Hastaneleri ( Site 0700)

    Sıhhiye, Ankara, 06230

Other trials in Turkey (Türkiye)

Brazil5 sites

  • Centro de Pesquisa Clinica do Coracao ( Site 0303)

    Aracaju, Sergipe, 49055-530

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

    Bragança Paulista, São Paulo, 12916-542

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

    Fortaleza, Ceará, 60430-350

  • IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)

    Rio de Janeiro, 20241-180

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

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

Other trials in Brazil

Israel5 sites

  • Barzilai Medical Center ( Site 0504)

    Ashkelon, 7830604

  • Linn Medical Center ( Site 0503)

    Haifa, 3100000

  • Rambam Health Care Campus ( Site 0500)

    Haifa, 3109601

  • Meir Medical Center. ( Site 0501)

    Kfar Saba, 4428164

  • Clalit Health Services - Sakhnin Community Clinic ( Site 0502)

    Sakhnin, 3081000

Other trials in Israel

New Zealand5 sites

  • Pacific Clinical Research Network - Forte ( Site 1004)

    Christchurch, Canterbury, 8013

  • Lakeland Clinical Trials Waikato ( Site 1000)

    Nawton, Waikato Region, 3200

  • Pacific Clinical Research Network - Tasman ( Site 1003)

    Nelson, Tasman District, 7011

  • Pacific Clinical Research Network - Rotorua ( Site 1001)

    Rotorua, Bay of Plenty, 3010

  • Lakeland Clinical Trials Wellington ( Site 1002)

    Upper Hutt, Wellington Region, 5018

Other trials in New Zealand

United Kingdom5 sites

  • Velocity Clinical Research Romford ( Site 0803)

    Bristol, Bristol, City of, BS8 2RA

  • Lakeside Surgery ( Site 0802)

    Corby, Northamptonshire, NN17 2UR

  • Velocity Clinical Research Havering ( Site 0804)

    London, Havering, RM1 3PJ

  • William Harvey Heart Centre ( Site 0800)

    London, London, City of, EC1M 6BQ

  • West Walk Surgery ( Site 0801)

    Yate, Gloucestershire, BS37 4AX

Other trials in United Kingdom

Hungary4 sites

  • Lausmed Egészségügyi Szolgáltató ( Site 1105)

    Baja, Bács-Kiskun county, 6500

  • DRC Gyógyszervizsgáló Központ ( Site 1109)

    Balatonfüred, Veszprém megye, 8230

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

    Debrecen, 4032

  • Borbánya Praxis ( Site 1103)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4405

Other trials in Hungary

Spain3 sites

  • EAP Sardenya ( Site 0601)

    Barcelona, 08025

  • EBA Centelles ( Site 0600)

    Barcelona, 08540

  • Centro de Salud Concepcion Arenal ( Site 0603)

    Santiago de Compostela, Galicia, 15701

Other trials in Spain

About this study

Official title: 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

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
Being tested
Enlicitide, Rosuvastatin, Placebo for Enlicitide, Placebo for Rosuvastatin
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnlicitideDrug

    Also called MK-0616, Enlicitide decanoate

    Oral Tablet

  • RosuvastatinDrug

    Oral Capsule

  • Placebo for EnlicitideDrug

    Oral Tablet

  • Placebo for RosuvastatinDrug

    Oral Capsule

Study groups in NCT07216482
Study groupRoleWhat they receive
EnlicitideExperimentalParticipants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
Receives: Drug: Enlicitide; Drug: Placebo for Rosuvastatin
Enlicitide + RosuvastatinExperimentalParticipants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
Receives: Drug: Enlicitide; Drug: Rosuvastatin
RosuvastatinActive comparatorParticipants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
Receives: Drug: Rosuvastatin; Drug: Placebo for Enlicitide
PlaceboPlacebo comparatorParticipants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.
Receives: Drug: Placebo for Enlicitide; Drug: Placebo for Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 8

Secondary outcomes (9)

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

    Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C.

    Measured: Baseline and Week 8

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

    Blood samples will be collected at baseline and at Week 8 to assess mean percent change in ApoB.

    Measured: Baseline and Week 8

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

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 20 weeks

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

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 12 weeks

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

    Blood samples will be collected at baseline and at Week 12 to assess mean percent change in LDL-C.

    Measured: Baseline and Week 12

  6. Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8

    Blood samples will be collected at baseline and at Week 8 to assess mean percent change in non-HDL-C.

    Measured: Baseline and Week 8

  7. Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8

    Blood samples will be collected at baseline and at Week 8 to assess percent change in Lp(a).

    Measured: Baseline and Week 8

  8. Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.

    Measured: Baseline and Week 8

  9. Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8

    Blood samples will be collected at baseline and at Week 8 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.

    Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2025
  2. Study start11 Nov 2025
  3. Primary completion3 Aug 2026
  4. Study completion5 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
996 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07216482
Sponsor's protocol ID
0616-037
Other IDs
U1111-1319-9502, 2025-521495-54-00, MK-0616-037, 2025
Status last verified
Aug 2026
First submitted
10 Oct 2025
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enlicitide and Rosuvastatin in people with Hyperlipidemia, run by Merck Sharp & Dohme LLC at 87 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Argentina, Australia, Canada, Turkey (Türkiye) and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07216482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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