A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Had a heart failure hospitalization within 3 months before Screening
Has unstable angina, a myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening
Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors
Trial design
Design model
Parallel
Treatments tested in this trial
Enlicitide Decanoate
DrugOral administration
Placebo
Other interventionOral administration
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Enlicitide DecanoateExperimental treatment 1 intervention
Group B: PlaceboOther 1 intervention
Trial outcomes
Primary outcomes
1
Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Time frame
Baseline and Week 242
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 32 Weeks3
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 24 WeeksSecondary outcomes
1
Mean Percent Change From Baseline in Non High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Time frame
Baseline and Week 242
Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.
Time frame
Baseline and Week 243
Percent Change From Baseline in Lipoprotein (a) (Lp(a)) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a)
Time frame
Baseline and Week 244
Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at 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.
Time frame
Baseline and Week 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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