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

June 17, 2026 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
975

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • CABA, Argentina, C1425AGC
        • Active, not recruiting
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0206)
      • Corrientes, Argentina, W3400AMZ
        • Active, not recruiting
        • Instituto de Cardiología "Juana F. Cabral"-Cardiología ( Site 0205)
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1407GTL
        • Active, not recruiting
        • CEMEDIC ( Site 0201)
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Active, not recruiting
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0202)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1061AAS
        • Active, not recruiting
        • CIPREC-CIPREC Sede Arenales ( Site 0200)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CVD
        • Active, not recruiting
        • Fundacion Estudios Clinicos ( Site 0203)
      • Rosario, Santa Fe Province, Argentina, S2000CVD
        • Active, not recruiting
        • Instituto de Investigaciones Clinicas Rosario ( Site 0204)
  • Australia
    • New South Wales
      • Maroubra, New South Wales, Australia, 2035
        • Active, not recruiting
        • Australian Clinical Research Network ( Site 0900)
      • Sydney, New South Wales, Australia, 2010
        • Active, not recruiting
        • Momentum Darlinghurst ( Site 0906)
    • Queensland
      • Taringa, Queensland, Australia, 4068
        • Active, not recruiting
        • Momentum Clinical Research Taringa ( Site 0907)
    • South Australia
      • Norwood, South Australia, Australia, 5067
        • Active, not recruiting
        • Fusion Clinical Research ( Site 0901)
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Active, not recruiting
        • Emeritus Research ( Site 0904)
      • Hoppers Crossing, Victoria, Australia, 3029
        • Active, not recruiting
        • Baker - HeartWest ( Site 0902)
  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Recruiting
        • IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +552125277979
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-350
        • Active, not recruiting
        • Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0306)
    • Sergipe
      • Aracaju, Sergipe, Brazil, 49055-530
        • Recruiting
        • Centro de Pesquisa Clinica do Coracao ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +557930259700
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916-542
        • Active, not recruiting
        • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0305)
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0309)
        • Contact:
          • Study Coordinator
          • Phone Number: +55173201-5054
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Active, not recruiting
        • G A Research Associates ( Site 0102)
    • Ontario
      • London, Ontario, Canada, N5W 6A2
        • Active, not recruiting
        • Milestone Research Inc. ( Site 0111)
      • North York, Ontario, Canada, M6B 3H7
        • Recruiting
        • North York Diagnostic and Cardiac Centre ( Site 0110)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-783-0000
      • Thunder Bay, Ontario, Canada, P7B 7C7
        • Recruiting
        • Care Access - Thunder Bay ( Site 0130)
        • Contact:
          • Study Coordinator
          • Phone Number: 8076955220
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Active, not recruiting
        • Centricity Research Mirabel Multispecialty ( Site 0107)
      • Montreal, Quebec, Canada, H1T 1C8
        • Active, not recruiting
        • Institut de Cardiologie de Montreal ( Site 0109)
      • Québec, Quebec, Canada, G1G 5X1
        • Active, not recruiting
        • Recherche Clinique Sigma Inc ( Site 0108)
  • Hungary
      • Debrecen, Hungary, 4032
        • Active, not recruiting
        • Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Anyagcsere Tanszék) ( Site 1102)
    • Bács-Kiskun county
      • Baja, Bács-Kiskun county, Hungary, 6500
        • Active, not recruiting
        • Lausmed Egészségügyi Szolgáltató ( Site 1105)
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4405
        • Active, not recruiting
        • Borbánya Praxis ( Site 1103)
    • Veszprém megye
      • Balatonfüred, Veszprém megye, Hungary, 8230
        • Active, not recruiting
        • DRC Gyógyszervizsgáló Központ ( Site 1109)
  • Israel
      • Ashkelon, Israel, 7830604
        • Active, not recruiting
        • Barzilai Medical Center ( Site 0504)
      • Haifa, Israel, 3100000
        • Active, not recruiting
        • Linn Medical Center ( Site 0503)
      • Haifa, Israel, 3109601
        • Active, not recruiting
        • Rambam Health Care Campus ( Site 0500)
      • Kfar Saba, Israel, 4428164
        • Active, not recruiting
        • Meir Medical Center. ( Site 0501)
      • Sakhnin, Israel, 3081000
        • Active, not recruiting
        • Clalit Health Services - Sakhnin Community Clinic ( Site 0502)
  • New Zealand
    • Bay of Plenty
      • Rotorua, Bay of Plenty, New Zealand, 3010
        • Active, not recruiting
        • Pacific Clinical Research Network - Rotorua ( Site 1001)
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8013
        • Active, not recruiting
        • Pacific Clinical Research Network - Forte ( Site 1004)
    • Tasman District
      • Nelson, Tasman District, New Zealand, 7011
        • Active, not recruiting
        • Pacific Clinical Research Network - Tasman ( Site 1003)
    • Waikato Region
      • Nawton, Waikato Region, New Zealand, 3200
        • Active, not recruiting
        • Lakeland Clinical Trials Waikato ( Site 1000)
    • Wellington Region
      • Upper Hutt, Wellington Region, New Zealand, 5018
        • Active, not recruiting
        • Lakeland Clinical Trials Wellington ( Site 1002)
  • Spain
      • Barcelona, Spain, 08540
        • Active, not recruiting
        • EBA Centelles ( Site 0600)
      • Barcelona, Spain, 08025
        • Active, not recruiting
        • EAP Sardenya ( Site 0601)
    • Galicia
      • Santiago de Compostela, Galicia, Spain, 15701
        • Active, not recruiting
        • Centro de Salud Concepcion Arenal ( Site 0603)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06520
        • Active, not recruiting
        • Ufuk University Dr.Ridvan Ege Hospital ( Site 0709)
      • Eskişehir, Turkey (Türkiye), 26480
        • Active, not recruiting
        • Eskisehir Osmangazi University ( Site 0705)
      • Istanbul, Turkey (Türkiye), 34080
        • Active, not recruiting
        • Istanbul Universitesi - Cerrahpasa Kardiyoloji Enstitusu ( Site 0703)
      • Izmir, Turkey (Türkiye), 35080
        • Active, not recruiting
        • Ege Universitesi Hastanesi ( Site 0708)
      • Kayseri, Turkey (Türkiye), 38030
        • Active, not recruiting
        • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 0701)
      • Malatya, Turkey (Türkiye), 44280
        • Active, not recruiting
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 0702)
    • Ankara
      • Sıhhiye, Ankara, Turkey (Türkiye), 06230
        • Active, not recruiting
        • Hacettepe Universite Hastaneleri ( Site 0700)
  • United Kingdom
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS8 2RA
        • Active, not recruiting
        • Velocity Clinical Research, Bristol ( Site 0803)
    • Gloucestershire
      • Yate, Gloucestershire, United Kingdom, BS37 4AX
        • Active, not recruiting
        • West Walk Surgery ( Site 0801)
    • Havering
      • London, Havering, United Kingdom, RM1 3PJ
        • Active, not recruiting
        • Velocity Clinical Research Havering ( Site 0804)
    • London, City of
      • London, London, City of, United Kingdom, EC1M 6BQ
        • Active, not recruiting
        • William Harvey Heart Centre ( Site 0800)
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN17 2UR
        • Active, not recruiting
        • Lakeside Surgery ( Site 0802)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Active, not recruiting
        • Central Research Associates ( Site 0009)
      • Foley, Alabama, United States, 36535
        • Active, not recruiting
        • G&L Research ( Site 0024)
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Active, not recruiting
        • Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)
      • Tempe, Arizona, United States, 85281
        • Active, not recruiting
        • Alliance for Multispecialty Research LLC ( Site 0049)
    • California
      • Lancaster, California, United States, 93534
        • Active, not recruiting
        • Chemidox Clinical Trials ( Site 0008)
      • Sacramento, California, United States, 95821
        • Active, not recruiting
        • Clinical Trials Research ( Site 0036)
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Active, not recruiting
        • Legacy Clinical Trials ( Site 0044)
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Active, not recruiting
        • Alliance for Multispecialty Research, LLC ( Site 0040)
      • Hollywood, Florida, United States, 33020
        • Active, not recruiting
        • Soffer Health Institute ( Site 0046)
      • Lake City, Florida, United States, 32055
        • Active, not recruiting
        • East Coast Institute for Research ( Site 0041)
      • Miami Lakes, Florida, United States, 33014
        • Active, not recruiting
        • Inpatient Research Clinic ( Site 0017)
      • Tampa, Florida, United States, 33607
        • Active, not recruiting
        • Clinical Research Trials of Florida ( Site 0001)
      • Winter Park, Florida, United States, 32789
        • Active, not recruiting
        • Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Active, not recruiting
        • Trialmed ( Site 0026)
      • Chicago, Illinois, United States, 60640
        • Active, not recruiting
        • Great Lakes Clinical Trials - Ravenswood ( Site 0018)
    • Indiana
      • Indianapolis, Indiana, United States, 46260-5310
        • Active, not recruiting
        • Midwest Institute For Clinical Research ( Site 0033)
    • Kansas
      • Newton, Kansas, United States, 67114
        • Active, not recruiting
        • Alliance for Multispecialty Research, LLC ( Site 0048)
      • Topeka, Kansas, United States, 66606
        • Active, not recruiting
        • Cotton O'Neil Clinical Research Center ( Site 0006)
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Active, not recruiting
        • Monroe Biomedical Research ( Site 0004)
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Active, not recruiting
        • Jubilee Clinical Research ( Site 0031)
    • New Jersey
      • Elmer, New Jersey, United States, 08318
        • Active, not recruiting
        • Cardiovascular Associates of the Delaware Valley ( Site 0035)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-4725
        • Active, not recruiting
        • New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Active, not recruiting
        • Alliance for Multispecialty Research, LLC - Norman ( Site 0043)
    • Pennsylvania
      • Yardley, Pennsylvania, United States, 19067
        • Active, not recruiting
        • Cardiology Consultants of Philadelphia Yardley ( Site 0016)
    • Texas
      • Houston, Texas, United States, 77027
        • Active, not recruiting
        • Provecta Research Network LLC ( Site 0022)
      • Odessa, Texas, United States, 79761
        • Active, not recruiting
        • Permian Research Foundation ( Site 0005)
      • Pearland, Texas, United States, 77584
        • Active, not recruiting
        • LinQ Research ( Site 0025)
      • San Antonio, Texas, United States, 78258
        • Active, not recruiting
        • Stone Oak, LLC dba Discovery Clinical Trials (DCT) ( Site 0021)
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • Clinical Trials of Texas, Inc. ( Site 0010)
      • Tomball, Texas, United States, 77375
        • Active, not recruiting
        • LinQ Research - Tomball ( Site 0047)
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Active, not recruiting
        • Manassas Clinical Research Center ( Site 0002)
      • Newport News, Virginia, United States, 23606
        • Active, not recruiting
        • Health Research of Hampton Roads, Inc. ( Site 0013)
      • Richmond, Virginia, United States, 23294
        • Active, not recruiting
        • National Clinical Research, Inc ( Site 0028)
      • Vienna, Virginia, United States, 22182
        • Active, not recruiting
        • Conquest Research ( Site 0045)
    • Washington
      • Renton, Washington, United States, 98057
        • Active, not recruiting
        • Rainier Clinical Research ( Site 0023)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enlicitide
Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
Drug: Enlicitide
Oral Tablet
Other Names:
  • MK-0616
  • Enlicitide decanoate
Drug: Placebo for Rosuvastatin
Oral Capsule
Experimental: Enlicitide + Rosuvastatin
Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
Drug: Enlicitide
Oral Tablet
Other Names:
  • MK-0616
  • Enlicitide decanoate
Drug: Rosuvastatin
Oral Capsule
Active Comparator: Rosuvastatin
Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
Drug: Rosuvastatin
Oral Capsule
Drug: Placebo for Enlicitide
Oral Tablet
Placebo Comparator: Placebo
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 Rosuvastatin
Oral Capsule
Drug: Placebo for Enlicitide
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)
Time Frame: Baseline and Week 8
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change from Baseline in LDL-C at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C.
Baseline and Week 8
Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in ApoB.
Baseline and Week 8
Number of Participants with One or More Adverse Events (AEs)
Time Frame: Up to approximately 20 weeks
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.
Up to approximately 20 weeks
Number of Participants who Discontinue Study Drug Due to One or More AEs
Time Frame: Up to approximately 12 weeks
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.
Up to approximately 12 weeks
Mean Percent Change from Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Blood samples will be collected at baseline and at Week 12 to assess mean percent change in LDL-C.
Baseline and Week 12
Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in non-HDL-C.
Baseline and Week 8
Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8
Time Frame: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess percent change in Lp(a).
Baseline and Week 8
Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8
Time Frame: Baseline and 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.
Baseline and Week 8
Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8
Time Frame: Baseline and 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.
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0616-037
  • U1111-1319-9502 (Registry Identifier: UTN)
  • 2025-521495-54-00 (Registry Identifier: EU CT)
  • MK-0616-037 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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