Open-label Extension Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
- 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
- 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
- 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
Scroll for more (212 remaining)Alliance for Multispecialty Research, LLC ( Site 0027)🇺🇸Daphne, Alabama, United StatesStudy CoordinatorContact251-901-2111