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A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults with Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)

ClinicalTrials.gov Identifier: NCT05952869 (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 Heterozygous Familial Hypercholesterolemia.

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial 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:
303
Study Start Date:
August 2023
Study Completion Date:
April 2025
Primary Completion Date:
April 2025
Ages Eligible for Study:
18 years and older
Genders Eligible for Study:
All
Accepts Healthy Volunteers:
No


CRITERIA

Inclusion Criteria:

  • Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
  • Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
  • Is treated with a moderate- or high-intensity statin medication
  • Is on a stable dose of all background lipid-lowering therapies (LLTs) 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

No Contacts or Locations in US/Canada Provided

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Clinical Study Reports

Synopsis  MK-0616-017


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