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

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia

Treatments: Drug: Enlicitide Decanoate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05952856

2022-502777-42 (Registry Identifier)

jRCT2031230320 (Registry Identifier)

0616-013

MK-0616-013 (Other Identifier)

U1111-1285-4164 (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 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: 2,760 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,760 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