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A Study of 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:  Active, not recruiting


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 MK-0616 in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that MK-0616 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
Estimated Enrollment:
270
Study Start Date:
August 2023
Estimated Study Completion Date:
April 2025
Estimated 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

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