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NCT Number: NCT06492291

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEDIC ( Site 0603), 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 completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study [MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)] per protocol (including the final assessments/procedures of their parent study)
  • Had an overall study intervention compliance ≥80% while participating in their parent study

Exclusion criteria

  • Has discontinued study intervention in their parent study
  • Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
  • Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
  • Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study

Treatment and study plan

Enlicitide Decanoate

Drug

Oral tablet

Other names: MK-0616, Enlicitide

Primary outcomes

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

    Time frame: Up to approximately 3 years

    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.

  2. Number of participants who discontinue study drug due to an AE

    Time frame: Up to approximately 3 years

    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 of the parent study in LDL-C at Week 8 of this extension study

    Time frame: Baseline of the parent study and Week 8 of this extension study

    The percent change from baseline in LDL-C. Each participant's baseline data from their parent study will be used as baseline data for this analysis.

  2. Mean percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension Study

    Time frame: Baseline of the parent study and Week 8 of this extension study

    The percent change from baseline in Non-HDL-C. Each participant's baseline data from their parent study will be used as baseline data for this analysis.

  3. Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study

    Time frame: Baseline of the parent study and Week 8 of this extension study

    The percent change from baseline in apolipoprotein B. Each participant's baseline data from their parent study will be used as baseline data for this analysis.

  4. Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study

    Time frame: Baseline of the parent study and Week 8 of this extension study

    The percent change from baseline in Lp(a). Each participant's baseline data from their parent study will be used as baseline data for this analysis.

  5. Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study

    Time frame: Baseline in the parent study and up to approximately 3 years in this extension study

    The percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline at any point during the study. Each participant's baseline data from their parent study will be used as baseline data for this analysis.

  6. Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study

    Time frame: Baseline in the parent study and up to approximately 3 years in this extension study

    The percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline at any point during the study. Each participant's baseline data from their parent study will be used as baseline data for this analysis.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2024
Registry last updated
Oct 7, 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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