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

Phase 3
Recruiting
Conditions
Hypercholesterolemia
Interventions
Registration Number
NCT06492291
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
3000
Inclusion Criteria
  • Has completed an enlicitide decanoate parent study [MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT Number pending)] 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 currently participating in an interventional clinical study other than an enlicitide decanoate parent study

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Enlicitide DecanoateEnlicitide DecanoateParticipants will receive 20 mg of enlicitide decanoate orally once daily (QD)
Primary Outcome Measures
NameTimeMethod
Number of participants with one or more adverse events (AEs)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.

Number of participants who discontinue study drug due to an AEUp 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 Outcome Measures
NameTimeMethod
Mean percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension StudyBaseline 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.

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

Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension studyBaseline 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.

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

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

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

Trial Locations

Locations (222)

Alliance for Multispecialty Research, LLC ( Site 0027)

🇺🇸

Daphne, Alabama, United States

G&L Research ( Site 0035)

🇺🇸

Foley, Alabama, United States

Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)

🇺🇸

Phoenix, Arizona, United States

National Heart Institute-Research ( Site 0029)

🇺🇸

Beverly Hills, California, United States

Clinical Trials Research ( Site 0054)

🇺🇸

Sacramento, California, United States

Velocity Clinical Research, Banning ( Site 0023)

🇺🇸

San Bernardino, California, United States

Emerson Clinical Research Institute ( Site 0017)

🇺🇸

Washington, District of Columbia, United States

Excel Medical Clinical Trials ( Site 0010)

🇺🇸

Boca Raton, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0037)

🇺🇸

Coral Gables, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0056)

🇺🇸

Fort Myers, Florida, United States

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Alliance for Multispecialty Research, LLC ( Site 0027)
🇺🇸Daphne, Alabama, United States
Study Coordinator
Contact
251-901-2111

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