A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
- 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.
- Short title
- A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-11-05
- First posted
- 2025-10-14
- Registry last updated
- 2026-09-01
- Primary completion date
- 2026-08-03
- Start date
- 2025-11-11
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07216482
- ClinicalTrials.gov ID
- NCT07216482
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Factorial
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Investigators, Outcome assessors
Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)
Timeframe: 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.
Mean Percent Change from Baseline in LDL-C at Week 8
Timeframe: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in LDL-C.
Mean Percent Change from Baseline in Apolipoprotein B (ApoB) at Week 8
Timeframe: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in ApoB.
Number of Participants with One or More Adverse Events (AEs)
Timeframe: 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.
Number of Participants who Discontinue Study Drug Due to One or More AEs
Timeframe: 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.
Mean Percent Change from Baseline in LDL-C at Week 12
Timeframe: Baseline and Week 12
Blood samples will be collected at baseline and at Week 12 to assess mean percent change in LDL-C.
Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8
Timeframe: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess mean percent change in non-HDL-C.
Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8
Timeframe: Baseline and Week 8
Blood samples will be collected at baseline and at Week 8 to assess percent change in Lp(a).
Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8
Timeframe: 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.
Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8
Timeframe: 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.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 64 Years
- Healthy volunteers
- No
-Has either not received lipid-lowering therapy (LLT) or has not received certain LLTs within a specified time period prior to the study.
- 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.
- Central Research Associates ( Site 0009)Birmingham, United States
- G&L Research ( Site 0024)Foley, United States
- Synexus Clinical Research US, Inc. - Phoenix Central ( Site 0030)Phoenix, United States
- Alliance for Multispecialty Research LLC ( Site 0049)Tempe, United States
- Chemidox Clinical Trials ( Site 0008)Lancaster, United States
- Clinical Trials Research ( Site 0036)Sacramento, United States
- Legacy Clinical Trials ( Site 0044)Colorado Springs, United States
- Alliance for Multispecialty Research, LLC ( Site 0040)Fort Myers, United States
- Soffer Health Institute ( Site 0046)Hollywood, United States
- East Coast Institute for Research ( Site 0041)Lake City, United States
- Inpatient Research Clinic ( Site 0017)Miami Lakes, United States
- Clinical Research Trials of Florida ( Site 0001)Tampa, United States
- Clinical Site Partners LLC, dba CSP Orlando ( Site 0014)Winter Park, United States
- Trialmed ( Site 0026)Chicago, United States
- Great Lakes Clinical Trials - Ravenswood ( Site 0018)Chicago, United States
- Midwest Institute For Clinical Research ( Site 0033)Indianapolis, United States
- Alliance for Multispecialty Research, LLC ( Site 0048)Newton, United States
- Cotton O'Neil Clinical Research Center ( Site 0006)Topeka, United States
- L-MARC Research Center ( Site 0004)Louisville, United States
- Jubilee Clinical Research ( Site 0031)Las Vegas, United States
- Cardiovascular Associates of the Delaware Valley ( Site 0035)Elmer, United States
- New Mexico Clinical Research & Osteoporosis Center, Inc. ( Site 0027)Albuquerque, United States
- Alliance for Multispecialty Research, LLC - Norman ( Site 0043)Norman, United States
- Cardiology Consultants of Philadelphia Yardley ( Site 0016)Yardley, United States
- Provecta Research Network LLC ( Site 0022)Houston, United States
And 62 more, listed on the interactive page.
- Related resource (www.merckclinicaltrials.com)
- MK-0616-037
- 2025
- U1111-1319-9502
- 2025-521495-54-00
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Hyperlipidemia Primary condition