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A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

ClinicalTrials.gov Identifier: NCT05952856 (view full study on clinicaltrials.gov)
Condition:  Hypercholesterolemia, Familial Hypercholesterolemia
Status:  Completed


Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

Study Type:
Interventional
Study Phase:
Phase 3
Enrollment:
2912
Study Start Date:
August 2023
Study Completion Date:
July 2025
Primary Completion Date:
July 2025
Ages Eligible for Study:
18 years and older
Genders Eligible for Study:
All
Accepts Healthy Volunteers:
No


CRITERIA

Inclusion Criteria:

  • Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
  • 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:

  • Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
  • Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
  • 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 without adequate washout

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