A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
- Conditions
- HypercholesterolemiaFamilial Hypercholesterolemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT05952856
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2760
- Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
- Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
- If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change.
- Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
- Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
- Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
- Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enlicitide Decanoate Enlicitide Decanoate Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks. Placebo Placebo Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.
- Primary Outcome Measures
Name Time Method Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Number of participants with one or more adverse events (AEs) Up to ~60 weeks 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 ~52 weeks 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 in LDL-C at Week 52 Baseline and Week 52 Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.
Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \<70 mg/dL and ≥50% reduction from baseline.
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24 Baseline and Week 24 Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C \<55 mg/dL and ≥50% reduction from baseline.
Trial Locations
- Locations (168)
Alliance for Multispecialty Research, LLC ( Site 0093)
🇺🇸Daphne, Alabama, United States
G&L Research ( Site 0043)
🇺🇸Foley, Alabama, United States
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
🇺🇸Phoenix, Arizona, United States
Velocity Clinical Research, Banning ( Site 0017)
🇺🇸Banning, California, United States
National Heart Institute-Research ( Site 0087)
🇺🇸Beverly Hills, California, United States
Clinical Trials Research ( Site 0115)
🇺🇸Sacramento, California, United States
Emerson Clinical Research Institute ( Site 0118)
🇺🇸Washington, District of Columbia, United States
Excel Medical Clinical Trials ( Site 0053)
🇺🇸Boca Raton, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0088)
🇺🇸Coral Gables, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0094)
🇺🇸Fort Myers, Florida, United States
Scroll for more (158 remaining)Alliance for Multispecialty Research, LLC ( Site 0093)🇺🇸Daphne, Alabama, United States