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: Drug: Enlicitide Decanoate

• 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

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2024-08-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-10
• Primary Completion: 2028-10-13
• Study Completion: 2028-10-13

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

Group	Intervention	Description
Enlicitide Decanoate	Enlicitide Decanoate	Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)

Primary Outcome Measures

Name	Time	Method
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 AE	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 Outcome Measures

Name	Time	Method
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	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.
Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study	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.
Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study	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.
Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study	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.
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study	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.
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study	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.

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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