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
- COMPLETED
- Sex
- All
- Target Recruitment
- 2912
- 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)
Synexus Clinical Research US, Inc. ( Site 0109)
🇺🇸Evansville, Indiana, United States
Velocity Clinical Research, Covington ( Site 0068)
🇺🇸Covington, Louisiana, United States
Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d ( Site 0009)
🇺🇸Rapid City, South Dakota, United States
Centricity Research Suffolk Family Medicine ( Site 0092)
🇺🇸Suffolk, Virginia, United States
The Second Affiliated Hospital of Chongqing Medical University ( Site 3320)
🇨🇳Chongqing, Chongqing Municipality, China
Zhujiang Hospital of Southern Medical University ( Site 3329)
🇨🇳Guangzhou, Guangdong, China
Universitaetsklinikum Carl Gustav Carus Dresden-Universitätsstudienzentrum für Stoffwechselerkranku ( Site 1508)
🇩🇪Dresden, Saxony, Germany
Meir Medical Center. ( Site 1714)
🇮🇱Kfar Saba, Israel
Shin Clinic ( Site 3517)
🇯🇵Ōta-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM Clinic ( Site 3502)
🇯🇵Shinjuku-ku, Tokyo, Japan
Scroll for more (158 remaining)Synexus Clinical Research US, Inc. ( Site 0109)🇺🇸Evansville, Indiana, United States