Hyperlipidemia
Conditions
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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change from Baseline in LDL-C at Week 8 (Enlicitide + Rosuvastatin Versus Placebo) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change from Baseline in LDL-C at Week 8 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
Argentina, Australia, Brazil, Canada, Hungary, Israel, New Zealand, Spain, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed