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
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 996
- Locations
- 142
- Primary Endpoint
- Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Enlicitide
Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
Intervention: Enlicitide (Drug)
Enlicitide
Participants will receive enlicitide and a rosuvastatin-matching placebo. Both will be delivered orally once daily (QD) for up to 12 weeks.
Intervention: Placebo for Rosuvastatin (Drug)
Enlicitide + Rosuvastatin
Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
Intervention: Enlicitide (Drug)
Rosuvastatin
Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
Intervention: Placebo for Enlicitide (Drug)
Enlicitide + Rosuvastatin
Participants will receive enlicitide and rosuvastatin. Both will be delivered orally QD for up to 12 weeks.
Intervention: Rosuvastatin (Drug)
Rosuvastatin
Participants will receive rosuvastatin and an enlicitide-matching placebo. Both will be delivered orally QD for up to 12 weeks.
Intervention: Rosuvastatin (Drug)
Placebo
Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.
Intervention: Placebo for Enlicitide (Drug)
Placebo
Participants will receive an enlicitide-matching placebo and a rosuvastatin-matching placebo. Placebos will be delivered orally QD for up to 12 weeks.
Intervention: Placebo for Rosuvastatin (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Mean Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) at Week 8(Baseline and Week 8)
- Percent Change from Baseline in Lipoprotein (a) (Lp[a]) at Week 8(Baseline and Week 8)
- Percentage of Participants with LDL-C <70 mg/dL and ≥50% Reduction from Baseline at Week 8(Baseline and Week 8)
- Percentage of Participants with LDL-C <55 mg/dL and ≥50% Reduction from Baseline at Week 8(Baseline and Week 8)