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Study · Randomized controlled trial · 2026

11 results

Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial.

Catapano AL, Mikhailova E, Navar AM, Banka P, Corral P, Saxena M, Steg PG, Verma S, Kordahi AY, Mendizabal G, Zhu P, Ballantyne CM

Journal of the American College of Cardiology30 Mar 2026Cited by 10 (Europe PMC)

PMID42017875 (opens in a new tab)DOI10.1016/j.jacc.2026.03.036 (opens in a new tab)PepBankPUB-42017875
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults with cardiovascular risk, enlicitide reduced LDL-C more than bempedoic acid.

    In plain wordsIn statin-treated adults, enlicitide reduced LDL-C more than bempedoic acid.

    Peptide
    Enlicitide
    Outcome
    DecreaseLDL-C change
    Study

    n: not reported in source

    Comparator
    Bempedoic acid
    Analysis
    Primary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Measurements

    LDL-C change
    −64.6%
    enlicitide
    LDL-C change
    −6.3%
    bempedoic acid

    Source sentences

    Summary
    The mean percentage change in LDL-C from baseline to day 56 was -64.6% (95% CI: -68.3% to -60.9%) with enlicitide, -6.3% (95% CI: -13.5% to 0.8%) with bempedoic acid, -27.8% (95% CI: -32.3% to -23.4%) with ezetimibe, and -36.5% (95% CI: -40.8% to -32.2%) with bempedoic acid plus ezetimibe; enlicitid…
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  2. 02HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults with cardiovascular risk, enlicitide reduced LDL-C more than ezetimibe.

    In plain wordsIn statin-treated adults, enlicitide reduced LDL-C more than ezetimibe.

    Peptide
    Enlicitide
    Outcome
    DecreaseLDL-C change
    Study

    n: not reported in source

    Comparator
    Ezetimibe
    Analysis
    Primary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Measurements

    LDL-C change
    −64.6%
    enlicitide
    LDL-C change
    −27.8%
    ezetimibe

    Source sentences

    Summary
    The mean percentage change in LDL-C from baseline to day 56 was -64.6% (95% CI: -68.3% to -60.9%) with enlicitide, -6.3% (95% CI: -13.5% to 0.8%) with bempedoic acid, -27.8% (95% CI: -32.3% to -23.4%) with ezetimibe, and -36.5% (95% CI: -40.8% to -32.2%) with bempedoic acid plus ezetimibe; enlicitid…
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  3. 03HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults with cardiovascular risk, enlicitide reduced LDL-C more than bempedoic acid plus ezetimibe.

    In plain wordsIn statin-treated adults, enlicitide reduced LDL-C more than bempedoic acid plus ezetimibe.

    Peptide
    Enlicitide
    Outcome
    DecreaseLDL-C change
    Study

    n: not reported in source

    Comparator
    Bempedoic acid plus ezetimibe
    Analysis
    Primary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Measurements

    LDL-C change
    −64.6%
    enlicitide
    LDL-C change
    −36.5%
    bempedoic acid plus ezetimibe

    Source sentences

    Summary
    The mean percentage change in LDL-C from baseline to day 56 was -64.6% (95% CI: -68.3% to -60.9%) with enlicitide, -6.3% (95% CI: -13.5% to 0.8%) with bempedoic acid, -27.8% (95% CI: -32.3% to -23.4%) with ezetimibe, and -36.5% (95% CI: -40.8% to -32.2%) with bempedoic acid plus ezetimibe; enlicitid…
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  4. 04HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults, enlicitide reduced ApoB more than bempedoic acid.

    In plain wordsIn statin-treated adults, enlicitide reduced ApoB more than bempedoic acid.

    Peptide
    Enlicitide
    Outcome
    DecreaseApoB reduction
    Study

    n: not reported in source

    Comparator
    Bempedoic acid
    Analysis
    Secondary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Source sentences

    Summary
    Reductions in ApoB and nonHDL-C were also greater with enlicitide (all P < 0.001).
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  5. 05HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults, enlicitide reduced ApoB more than ezetimibe.

    In plain wordsIn statin-treated adults, enlicitide reduced ApoB more than ezetimibe.

    Peptide
    Enlicitide
    Outcome
    DecreaseApoB reduction
    Study

    n: not reported in source

    Comparator
    Ezetimibe
    Analysis
    Secondary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Source sentences

    Summary
    Reductions in ApoB and nonHDL-C were also greater with enlicitide (all P < 0.001).
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  6. 06HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults, enlicitide reduced ApoB more than bempedoic acid plus ezetimibe.

    In plain wordsIn statin-treated adults, enlicitide reduced ApoB more than bempedoic acid plus ezetimibe.

    Peptide
    Enlicitide
    Outcome
    DecreaseApoB reduction
    Study

    n: not reported in source

    Comparator
    Bempedoic acid plus ezetimibe
    Analysis
    Secondary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Source sentences

    Summary
    Reductions in ApoB and nonHDL-C were also greater with enlicitide (all P < 0.001).
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  7. 07HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults, enlicitide reduced nonHDL-C more than bempedoic acid.

    In plain wordsIn statin-treated adults, enlicitide reduced nonHDL-C more than bempedoic acid.

    Peptide
    Enlicitide
    Outcome
    DecreaseNonHDL-C reduction
    Study

    n: not reported in source

    Comparator
    Bempedoic acid
    Analysis
    Secondary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Source sentences

    Summary
    Reductions in ApoB and nonHDL-C were also greater with enlicitide (all P < 0.001).
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  8. 08HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults, enlicitide reduced nonHDL-C more than ezetimibe.

    In plain wordsIn statin-treated adults, enlicitide reduced nonHDL-C more than ezetimibe.

    Peptide
    Enlicitide
    Outcome
    DecreaseNonHDL-C reduction
    Study

    n: not reported in source

    Comparator
    Ezetimibe
    Analysis
    Secondary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Source sentences

    Summary
    Reductions in ApoB and nonHDL-C were also greater with enlicitide (all P < 0.001).
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  9. 09HumanRandomized controlled trialEfficacy outcome

    In statin-treated adults, enlicitide reduced nonHDL-C more than bempedoic acid plus ezetimibe.

    In plain wordsIn statin-treated adults, enlicitide reduced nonHDL-C more than bempedoic acid plus ezetimibe.

    Peptide
    Enlicitide
    Outcome
    DecreaseNonHDL-C reduction
    Study

    n: not reported in source

    Comparator
    Bempedoic acid plus ezetimibe
    Analysis
    Secondary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Source sentences

    Summary
    Reductions in ApoB and nonHDL-C were also greater with enlicitide (all P < 0.001).
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  10. 10HumanRandomized controlled trialSafety outcome

    In statin-treated adults, adverse event proportions were similar across enlicitide and the other treatment arms.

    In plain wordsIn statin-treated adults, adverse event proportions were similar across enlicitide and the other treatment arms.

    Peptide
    Enlicitide
    Outcome
    No significant changeAdverse event proportions
    Study

    n: not reported in source

    Comparator
    Other treatment arms
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Source sentences

    Summary
    Proportions of participants with AEs and discontinuations due to AEs were similar across treatment arms.
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial
  11. 11HumanRandomized controlled trialSafety outcome

    In statin-treated adults, discontinuations due to adverse events were similar across enlicitide and the other treatment arms.

    In plain wordsIn statin-treated adults, discontinuations for adverse events were similar across enlicitide and the other treatment arms.

    Peptide
    Enlicitide
    Outcome
    No significant changeDiscontinuations due to adverse events
    Study

    n: not reported in source

    Comparator
    Other treatment arms
    Outcome group
    Adverse events · Whole body
    Studied dose
    20 mg once daily · oral · 56 daysAs given in this study (human).

    Source sentences

    Summary
    Proportions of participants with AEs and discontinuations due to AEs were similar across treatment arms.
    1 context sentence
    Summary · context
    In this phase 3, randomized, double-blind, active-comparator trial

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT06450366

A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)

Merck Sharp & Dohme LLCn = 3018 Jul 2024 to 28 Mar 2025

Hypercholesterolemia

Trial pageClinicalTrials.govUpdated 27 Mar 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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