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Completed

NCT Number: NCT05952869

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

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.

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Key information

Conditions

Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Familial Hypercholesterolemia Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808), Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enlicitide Decanoate

Drug

Oral tablet

Other names: MK-0616

Placebo

Drug

Oral tablet (placebo).

Primary outcomes

  1. Mean Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24

    Time frame: Baseline and Week 24

    Blood samples were collected at baseline and at Week 24 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.

  2. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 64 weeks (8 weeks postdose)

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  3. Number of Participants Who Discontinued Study Drug Due to an AE

    Time frame: Up to 56 weeks

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Secondary outcomes

  1. Mean Percent Change From Baseline in LDL-C at Week 52

    Time frame: Baseline and Week 52

    Blood samples were collected at baseline and at Week 52 to determine mean percent change in LDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline LDL-C as a covariate.

  2. Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24

    Time frame: Baseline and Week 24

    Blood samples were collected at baseline and at Week 24 to determine mean percent change in non-HDL-C. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline non-HDL-C as a covariate.

  3. Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24

    Time frame: Baseline and Week 24

    Blood samples were collected at baseline and at Week 24 to determine mean percent change in ApoB. The two treatment groups were compared using an analysis of covariance model with treatment as a fixed effect and baseline ApoB as a covariate.

  4. Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24

    Time frame: Baseline and Week 24

    Blood samples were collected at baseline and at Week 24 to determine percent change in Lp(a). For percent change in Lp(a) at Week 24, the two treatment groups were analyzed using the Wilcoxon signed rank test with Hodges-Lehmann estimation.

  5. Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24

    Time frame: Baseline and Week 24

    Blood samples were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C <70 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.

  6. Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24

    Time frame: Baseline and Week 24

    Blood samples were collected at baseline and at Week 24 to determine the percentage of participants who had LDL-C <55 mg/dL and ≥50% reduction from baseline. The two treatment groups were analyzed based on the Miettinen and Nurminen method for the difference in percentage.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2023
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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