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Completed

NCT Number: NCT05952856

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

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.

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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

CEDIC ( Site 0612), CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Enlicitide Decanoate

Drug

Oral tablet

Other names: MK-0616

Placebo

Drug

Oral tablet

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 will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.

  2. Number of participants with one or more adverse events (AEs)

    Time frame: Up to ~60 weeks

    An AE is 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 discontinue study drug due to an AE

    Time frame: Up to ~52 weeks

    An AE is 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 will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.

  2. Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.

  3. Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.

  4. Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24

    Time frame: Baseline and Week 24

    Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).

  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 will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.

  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 will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.

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 Hypercholesterolemia

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2023
Registry last updated
Sep 10, 2025

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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