Phase 3
Completed N=303
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
Source: ClinicalTrials.gov NCT05952869 ↗Enrolled (actual)
303
Serious AEs
4.3%
Results posted
Feb 2026
Primary outcomePrimary: Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24 — -58.2; 2.6 Percent Change — p=<0.001
◆ Published Evidence
Established
44citations · ~44 / year
Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial.
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.
Linked Publications
-
Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial.
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 |
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
Data sourced from ClinicalTrials.gov (NCT05952869) and the linked publication. 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. Informational only — not medical advice.