Phase 3 N=303 Randomized Triple-blind Treatment

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

Hypercholesterolemia · Familial Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT05952869 ↗

Enrolled (actual)

303

Serious AEs

4.3%

Results posted

Feb 2026

Primary outcome: Primary: Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 — -58.2; 2.6 Percent Change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Enlicitide Decanoate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Apr 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24	-58.2; 2.6	<0.001 sig
PRIMARY Number of Participants With Adverse Events (AEs)	157; 77	—
PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE	4; 3	—
SECONDARY Mean Percent Change From Baseline in LDL-C at Week 52	-55.3; 8.7	<0.001 sig
SECONDARY Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24	-52.3; 2.1	<0.001 sig
SECONDARY Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24	-48.2; 1.8	<0.001 sig
SECONDARY Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24	-24.7; -1.6	<0.001 sig
SECONDARY Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24	70.8; 1.0	<0.001 sig
SECONDARY Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24	67.3; 1.0	<0.001 sig

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05952869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.