Hypercholesterolemia, Hyperlipidemia
Conditions
Brief summary
Researchers are looking for new ways to treat high cholesterol. Cholesterol is a type of fat in the blood. Enlicitide (also known as enlicitide decanoate or MK-0616), the study medicine, is in a class of medicines designed to lower low-density lipoprotein cholesterol (LDL-C). LDL-C is sometimes called "bad cholesterol." The goal of this study is to learn if enlicitide works better than placebo to lower the amount of LDL-C in a person's blood. Researchers also want to learn about the safety of enlicitide and if people tolerate it.
Interventions
Oral administration
OTHERPlacebo
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * History of a major atherosclerotic cardiovascular disease (ASCVD) event or if no history of a major ASCVD event, has one or more of the following: possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH), diabetes mellitus, stable angina pectoris, transient ischemic attack or symptomatic peripheral arterial disease * Has a low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL or ≥70 mg/dL depending on medical history * Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance * If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 | Baseline and Week 24 | Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C. |
| Number of Participants with One or More Adverse Events (AEs) | Up to approximately 32 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 24 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Non High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 | Baseline and Week 24 | Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C. |
| Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 | Baseline and Week 24 | Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB. |
| Percent Change From Baseline in Lipoprotein (a) (Lp(a)) at Week 24 | Baseline and Week 24 | Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a) |
| Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24 | Baseline and Week 24 | Blood samples will be collected at baseline and at Week 24 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 24 | Baseline and Week 24 | Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \<55 mg/dL and ≥50% reduction from baseline. |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed