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Study · Randomized controlled trial · 2023

6 results

Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616.

Ballantyne CM, Banka P, Mendez G, Garcia R, Rosenstock J, Rodgers A, Mendizabal G, Mitchel Y, Catapano AL

Journal of the American College of Cardiology6 Mar 2023Cited by 162 (Europe PMC)

PMID36889610 (opens in a new tab)DOI10.1016/j.jacc.2023.02.018 (opens in a new tab)PepBankPUB-36889610
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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with hypercholesterolemia, MK-0616 at 6 mg reduced LDL-C by 41.2% relative to placebo at Week 8.

    In plain wordsIn adults with hypercholesterolemia, MK-0616 at 6 mg reduced LDL-C more than placebo.

    Peptide
    Enlicitide
    Outcome
    DecreaseLDL-C change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    6 mg once daily · oral · 8 weeksAs given in this study (human).

    Measurements

    Placebo-adjusted LDL-C change
    −41.2%
    6 mg

    Source sentences

    Summary
    Among 380 treated participants, all doses of MK-0616 demonstrated statistically significant (P < 0.001) differences in least squares mean percentage change in LDL-C from baseline to Week 8 vs placebo: -41.2% (6 mg), -55.7% (12 mg), -59.1% (18 mg), and -60.9% (30 mg).
    2 context sentences
    Summary · context
    This Phase 2b, randomized, double-blind, placebo-controlled, multicenter trial aimed to evaluate the efficacy and safety of MK-0616 in participants with hypercholesterolemia.
    Summary · context
    Participants were assigned randomly (1:1:1:1:1 ratio) to MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with hypercholesterolemia, MK-0616 at 12 mg reduced LDL-C by 55.7% relative to placebo at Week 8.

    In plain wordsIn adults with hypercholesterolemia, MK-0616 at 12 mg reduced LDL-C more than placebo.

    Peptide
    Enlicitide
    Outcome
    DecreaseLDL-C change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    12 mg once daily · oral · 8 weeksAs given in this study (human).

    Measurements

    Placebo-adjusted LDL-C change
    −55.7%
    12 mg

    Source sentences

    Summary
    Among 380 treated participants, all doses of MK-0616 demonstrated statistically significant (P < 0.001) differences in least squares mean percentage change in LDL-C from baseline to Week 8 vs placebo: -41.2% (6 mg), -55.7% (12 mg), -59.1% (18 mg), and -60.9% (30 mg).
    2 context sentences
    Summary · context
    This Phase 2b, randomized, double-blind, placebo-controlled, multicenter trial aimed to evaluate the efficacy and safety of MK-0616 in participants with hypercholesterolemia.
    Summary · context
    Participants were assigned randomly (1:1:1:1:1 ratio) to MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with hypercholesterolemia, MK-0616 at 18 mg reduced LDL-C by 59.1% relative to placebo at Week 8.

    In plain wordsIn adults with hypercholesterolemia, MK-0616 at 18 mg reduced LDL-C more than placebo.

    Peptide
    Enlicitide
    Outcome
    DecreaseLDL-C change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    18 mg once daily · oral · 8 weeksAs given in this study (human).

    Measurements

    Placebo-adjusted LDL-C change
    −59.1%
    18 mg

    Source sentences

    Summary
    Among 380 treated participants, all doses of MK-0616 demonstrated statistically significant (P < 0.001) differences in least squares mean percentage change in LDL-C from baseline to Week 8 vs placebo: -41.2% (6 mg), -55.7% (12 mg), -59.1% (18 mg), and -60.9% (30 mg).
    2 context sentences
    Summary · context
    This Phase 2b, randomized, double-blind, placebo-controlled, multicenter trial aimed to evaluate the efficacy and safety of MK-0616 in participants with hypercholesterolemia.
    Summary · context
    Participants were assigned randomly (1:1:1:1:1 ratio) to MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with hypercholesterolemia, MK-0616 at 30 mg reduced LDL-C by 60.9% relative to placebo at Week 8.

    In plain wordsIn adults with hypercholesterolemia, MK-0616 at 30 mg reduced LDL-C more than placebo.

    Peptide
    Enlicitide
    Outcome
    DecreaseLDL-C change
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    30 mg once daily · oral · 8 weeksAs given in this study (human).

    Measurements

    Placebo-adjusted LDL-C change
    −60.9%
    30 mg

    Source sentences

    Summary
    Among 380 treated participants, all doses of MK-0616 demonstrated statistically significant (P < 0.001) differences in least squares mean percentage change in LDL-C from baseline to Week 8 vs placebo: -41.2% (6 mg), -55.7% (12 mg), -59.1% (18 mg), and -60.9% (30 mg).
    2 context sentences
    Summary · context
    This Phase 2b, randomized, double-blind, placebo-controlled, multicenter trial aimed to evaluate the efficacy and safety of MK-0616 in participants with hypercholesterolemia.
    Summary · context
    Participants were assigned randomly (1:1:1:1:1 ratio) to MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.
  5. 05HumanRandomized controlled trialSafety outcome

    In adults with hypercholesterolemia, adverse events occurred in 39.5% to 43.4% of participants across the MK-0616 arms and in 44.0% with placebo.

    In plain wordsIn adults with hypercholesterolemia, adverse event proportions were similar with MK-0616 and placebo.

    Peptide
    Enlicitide
    Outcome
    No significant changeAdverse event proportions
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    6, 12, 18 or 30 mg once daily · oral · 8 weeksAs given in this study (human).

    Measurements

    Adverse events
    39.5 to 43.4%
    MK-0616 arms
    Adverse events
    44%
    placebo

    Source sentences

    Summary
    AEs occurred in a similar proportion of participants in the MK-0616 arms (39.5% to 43.4%) as placebo (44.0%).
    2 context sentences
    Summary · context
    This Phase 2b, randomized, double-blind, placebo-controlled, multicenter trial aimed to evaluate the efficacy and safety of MK-0616 in participants with hypercholesterolemia.
    Summary · context
    Participants were assigned randomly (1:1:1:1:1 ratio) to MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with hypercholesterolemia, adverse events caused discontinuation in 2 or fewer participants per treatment group, including MK-0616 groups.

    In plain wordsIn adults with hypercholesterolemia, adverse events caused discontinuation in 2 or fewer participants per group, including MK-0616 groups.

    Peptide
    Enlicitide
    Outcome
    Direction not reportedDiscontinuations due to adverse events
    Study

    n: not reported in source

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    6, 12, 18 or 30 mg once daily · oral · 8 weeksAs given in this study (human).

    Measurements

    Discontinuations
    ≤ 2 participants
    each treatment group

    Source sentences

    Summary
    Discontinuations due to AEs occurred in 2 or fewer participants in any treatment group.
    2 context sentences
    Summary · context
    This Phase 2b, randomized, double-blind, placebo-controlled, multicenter trial aimed to evaluate the efficacy and safety of MK-0616 in participants with hypercholesterolemia.
    Summary · context
    Participants were assigned randomly (1:1:1:1:1 ratio) to MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.

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 2Results postedNCT05261126

A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

Merck Sharp & Dohme LLCn = 38110 Mar 2022 to 28 Nov 2022

Hypercholesterolemia · Familial Hypercholesterolemia

Trial pageClinicalTrials.govUpdated 9 Dec 2024

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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