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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Enlicitide Decanoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05952869

U1111-1285-4257 (Other Identifier)

0616-017

2022-502782-14 (Registry Identifier)

MK-0616-017 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 2 patient groups, including a placebo group

Enlicitide Decanoate

Experimental group

Description:

Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.

Treatment:

Drug: Enlicitide Decanoate

Placebo

Placebo Comparator group

Description:

Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.

Treatment:

Drug: Placebo