A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
- Conditions
- HypercholesterolemiaFamilial Hypercholesterolemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT05952869
- 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 heterozygous familial 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
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
- Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
- Has an LDL-C ≥55 mg/dL or ≥70 mg/dL depending on medical history
- Is treated with a moderate- or high-intensity statin medication
- Is on a stable dose of all background lipid-lowering therapies (LLTs) 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks. Enlicitide Decanoate Enlicitide Decanoate Participants will receive 20 mg of enlicitide decanoate orally once daily (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 (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 (59)
Alliance for Multispecialty Research, LLC ( Site 0023)
🇺🇸Daphne, Alabama, United States
Excel Medical Clinical Trials ( Site 0008)
🇺🇸Boca Raton, Florida, United States
Advanced Pharma Research ( Site 0007)
🇺🇸Cutler Bay, Florida, United States
Progressive Medical Research ( Site 0021)
🇺🇸Port Orange, Florida, United States
Clinical Site Partners LLC, dba CSP Orlando ( Site 0028)
🇺🇸Winter Park, Florida, United States
Synexus Clinical Research US - Evansville ( Site 0031)
🇺🇸Evansville, Indiana, United States
Franciscan Physician Network - Indiana Heart Physicians ( Site 0040)
🇺🇸Indianapolis, Indiana, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0001)
🇺🇸Troy, Michigan, United States
Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0026)
🇺🇸Lincoln, Nebraska, United States
Jubilee Clinical Research ( Site 0030)
🇺🇸Las Vegas, Nevada, United States
Scroll for more (49 remaining)Alliance for Multispecialty Research, LLC ( Site 0023)🇺🇸Daphne, Alabama, United States