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

Phase 3Active Not RecruitingNCT07216482

Merck Sharp & Dohme LLC996 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

996

Conditions

Hyperlipidemia

Interventions

Enlicitide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (87)

Central Research Associates ( Site 0009)

Birmingham, Alabama, United States

G&L Research ( Site 0024)

Foley, Alabama, United States

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

Phoenix, Arizona, United States

Alliance for Multispecialty Research LLC ( Site 0049)

Tempe, Arizona, United States

Chemidox Clinical Trials ( Site 0008)

Lancaster, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 8

Secondary Outcomes

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.

Time frame: Baseline and Week 8

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.

Time frame: Baseline and Week 8

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.

Time frame: Up to approximately 20 weeks

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.

Time frame: Up to approximately 12 weeks

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.

Time frame: Baseline and Week 12

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.

Time frame: Baseline and Week 8

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).

Time frame: Baseline and Week 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.

Time frame: Baseline and Week 8

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.

Time frame: Baseline and Week 8