Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

NCT06492291
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
3,000
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2024-08-05
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Number of sites
222
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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).
clinicaltrials.gov
Short title
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
clinicaltrials.gov
Official title
A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-10-13
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First posted
2024-07-09
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Registry last updated
2025-10-07
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Primary completion date
2028-10-13
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Start date
2024-08-05
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Participants
3,000
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Participant count basis
Estimated
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Planned participants
3,000
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Protocol amendments
2
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Number of sites
222
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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
NCT06492291
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ClinicalTrials.gov ID
NCT06492291
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with one or more adverse events (AEs)

    Timeframe: 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.

  2. Number of participants who discontinue study drug due to an AE

    Timeframe: 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.

  1. Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study

    Timeframe: 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.

  2. 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

    Timeframe: 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.

  3. Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study

    Timeframe: 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.

  4. Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study

    Timeframe: 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.

  5. Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study

    Timeframe: 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.

  6. Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

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

  • Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study [MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)] 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 planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
  • Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study
Sources for eligibility
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  • Alliance for Multispecialty Research, LLC ( Site 0027)Daphne, United States
  • G&L Research ( Site 0035)Foley, United States
  • Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0048)Phoenix, United States
  • National Heart Institute-Research ( Site 0029)Beverly Hills, United States
  • Clinical Trials Research ( Site 0054)Sacramento, United States
  • Velocity Clinical Research, Banning ( Site 0023)San Bernardino, United States
  • Emerson Clinical Research Institute ( Site 0017)Washington D.C., United States
  • Excel Medical Clinical Trials ( Site 0010)Boca Raton, United States
  • Alliance for Multispecialty Research, LLC ( Site 0037)Doral, United States
  • Alliance for Multispecialty Research, LLC ( Site 0056)Fort Myers, United States
  • Velocity Clinical Research, Hallandale Beach ( Site 0053)Hallandale, United States
  • Jacksonville Center for Clinical Research ( Site 0025)Jacksonville, United States
  • South Broward Research ( Site 0012)Miramar, United States
  • Progressive Medical Research ( Site 0033)Port Orange, United States
  • Clinical Research Trials of Florida ( Site 0006)Tampa, United States
  • Clinical Site Partners, LLC dba Flourish Research ( Site 0004)Winter Park, United States
  • East Coast Institute for Research, LLC ( Site 0020)Macon, United States
  • Healthcare Research Network - Chicago ( Site 0051)Flossmoor, United States
  • Synexus Clinical Research US - Evansville ( Site 0005)Evansville, United States
  • Midwest Institute For Clinical Research ( Site 0052)Indianapolis, United States
  • Alliance for Multispecialty Research, LLC ( Site 0001)Lexington, United States
  • L-MARC Research Center ( Site 0011)Louisville, United States
  • Velocity Clinical Research, Covington ( Site 0026)Covington, United States
  • Velocity Clinical Research Rockville ( Site 0022)Rockville, United States
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)Troy, United States

And 197 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • MK-0616-019
  • 2023
  • U1111-1290-3950
  • jRCT2051240110
  • 2023-504922-20-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)