A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

NCT05952856
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Phase
Phase 3
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Recruitment status
Completed
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Participants
2,912
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2023-08-10
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Number of sites
168
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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.
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Short title
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
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Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2025-07-28
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First posted
2023-07-19
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Registry last updated
2026-08-06
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Primary completion date
2025-07-28
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Start date
2023-08-10
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Actual participants
2,912
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Participants
2,912
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
168
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05952856
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ClinicalTrials.gov ID
NCT05952856
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Mean Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

    Timeframe: Baseline and Week 24

    Blood samples collected at baseline and Week 24 were used to assess mean percent change in LDL-C.

  2. Number of Participants With One or More Adverse Events (AEs)

    Timeframe: 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.

  3. Number of Participants Who Discontinued Study Drug Due to an AE

    Timeframe: 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.

  1. Mean Percent Change From Baseline in LDL-C at Week 52

    Timeframe: Baseline and Week 52

    Blood samples collected at baseline and Week 52 were used to assess mean percent change in LDL-C.

  2. Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24

    Timeframe: Baseline and Week 24

    Blood samples collected at baseline and Week 24 were used to assess mean percent change in non-HDL-C.

  3. Mean Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24

    Timeframe: Baseline and Week 24

    Blood samples collected at baseline and Week 24 were used to assess mean percent change in ApoB.

  4. Percent Change From Baseline in Lipoprotein(a) (Lp(a)) at Week 24

    Timeframe: Baseline and Week 24

    Blood samples collected at baseline and Week 24 were used to assess percent change in Lp(a).

  5. Percentage of Participants With LDL-C <70 mg/dL and ≥50% Reduction From Baseline at Week 24

    Timeframe: Baseline and Week 24

    Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C \<70 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal.

  6. Percentage of Participants With LDL-C <55 mg/dL and ≥50% Reduction From Baseline at Week 24

    Timeframe: Baseline and Week 24

    Blood samples collected at baseline and Week 24 were used to assess the percentage of participants who have LDL-C \<55 mg/dL and ≥50% reduction from baseline. Participants who did not have a Week 24 assessment are considered as not being at the LDL-C goal.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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
Sources for eligibility
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  • Alliance for Multispecialty Research, LLC ( Site 0093)Daphne, United States
  • G&L Research ( Site 0043)Foley, United States
  • Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)Phoenix, United States
  • National Heart Institute-Research ( Site 0087)Beverly Hills, United States
  • Clinical Trials Research ( Site 0115)Sacramento, United States
  • Velocity Clinical Research, Banning ( Site 0017)San Bernardino, United States
  • Emerson Clinical Research Institute ( Site 0118)Washington D.C., United States
  • Excel Medical Clinical Trials ( Site 0053)Boca Raton, United States
  • Alliance for Multispecialty Research, LLC ( Site 0088)Coral Gables, United States
  • Alliance for Multispecialty Research, LLC ( Site 0094)Fort Myers, United States
  • Velocity Clinical Research, Hallandale Beach ( Site 0018)Hallandale, United States
  • Jacksonville Center for Clinical Research ( Site 0049)Jacksonville, United States
  • South Broward Research ( Site 0051)Miramar, United States
  • Clinical Research Trials of Florida ( Site 0063)Tampa, United States
  • East Coast Institute for Research, LLC ( Site 0033)Macon, United States
  • Healthcare Research Network - Chicago ( Site 0052)Flossmoor, United States
  • Synexus Clinical Research US, Inc. ( Site 0109)Evansville, United States
  • Midwest Institute For Clinical Research ( Site 0059)Indianapolis, United States
  • Alliance for Multispecialty Research, LLC ( Site 0028)Lexington, United States
  • L-MARC Research Center ( Site 0001)Louisville, United States
  • Velocity Clinical Research, Covington ( Site 0068)Covington, United States
  • Velocity Clinical Research Rockville ( Site 0082)Rockville, United States
  • Velocity Clinical Research, Gulfport ( Site 0039)Gulfport, United States
  • Healthcare Research Network - St. Louis ( Site 0054)Hazelwood, United States
  • Jubilee Clinical Research ( Site 0106)Las Vegas, United States

And 143 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-0616-013
  • U1111-1285-4164
  • 2022-502777-42-00
  • jRCT2031230320
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)