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

NCTNCT06492291Other id0616-019Other id2023-504922-20-00Other idU1111-1290-3950Other idjRCT2051240110

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 3
Enrollment: 3,000 participants (estimated)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 28 countries
United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Start: 5 Aug 2024
Primary completion: 13 Oct 2028 (estimated)
Completion: 13 Oct 2028 (estimated)
First posted: 9 Jul 2024
Last update posted: 7 Oct 2025
Conditions: Hypercholesterolemia

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026202720282029

Ph 3
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
NCT06492291
5 Aug 2024 to est. 13 Oct 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

Enlicitide DecanoateDrug

Arms1

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

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of participants with one or more adverse events (AEs)
Time frame · Up to approximately 3 years
Registry description
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
Time frame · Up to approximately 3 years
Registry description
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(6)

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
Registry description
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 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
Registry description
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.
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
Registry description
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.
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
Registry description
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.
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
Registry description
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
Time frame · Baseline in the parent study and up to approximately 3 years in this extension study
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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