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Study · Randomized controlled trial · n = 73 · 2023

4 results

A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease.

Romero-Gómez M, Lawitz E, Shankar RR, Chaudhri E, Liu J, Lam RLH, Kaufman KD, Engel SS

Journal of hepatology22 Jun 2023Cited by 186 (Europe PMC)

PMID37355043 (opens in a new tab)DOI10.1016/j.jhep.2023.05.013 (opens in a new tab)PepBankPUB-37355043
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 study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with non-alcoholic fatty liver disease, semaglutide 1 mg weekly reduced liver fat content by 42.3% from baseline at week 24, less than efinopegdutide.

    In plain wordsIn adults with fatty liver disease, semaglutide reduced liver fat, but by less than the comparison drug efinopegdutide.

    Peptide
    Semaglutide
    Outcome
    DecreaseRelative reduction in liver fat content at week 24
    Study

    n = 73

    Comparator
    Efinopegdutide 10 mg
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    LS mean relative reduction in LFC
    42.3%
    semaglutide 1 mg, week 24

    Source sentences

    Summary
    The least squares (LS) mean relative reduction from baseline in LFC at Week 24 was significantly (p <0.001) greater with efinopegdutide (72.7% [90% CI 66.8-78.7]) than with semaglutide (42.3% [90% CI 36.5-48.1]).
    1 context sentence
    Summary · context
    Participants with an LFC of ≥10% at screening were randomized 1:1 to efinopegdutide 10 mg or semaglutide 1 mg, both administered subcutaneously once weekly for 24 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with non-alcoholic fatty liver disease, semaglutide 1 mg weekly reduced body weight by 7.1% at week 24, with no significant difference from efinopegdutide (8.5%).

    In plain wordsIn adults with fatty liver disease, semaglutide lowered body weight, with no clear difference from efinopegdutide.

    Peptide
    Semaglutide
    Outcome
    DecreasePercent body weight reduction at week 24
    Study

    n = 73

    Comparator
    Efinopegdutide 10 mg
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    LS mean body weight reduction
    7.1%
    semaglutide 1 mg, week 24

    Source sentences

    Summary
    Both treatment groups had an LS mean percent reduction from baseline in body weight at Week 24 (efinopegdutide 8.5% vs. semaglutide 7.1%; p = 0.085).
    1 context sentence
    Summary · context
    Participants with an LFC of ≥10% at screening were randomized 1:1 to efinopegdutide 10 mg or semaglutide 1 mg, both administered subcutaneously once weekly for 24 weeks.
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with non-alcoholic fatty liver disease, adverse events and drug-related adverse events were slightly less frequent with semaglutide than with efinopegdutide.

    In plain wordsIn adults with fatty liver disease, semaglutide caused slightly fewer side effects than efinopegdutide.

    Peptide
    Semaglutide
    Outcome
    DecreaseAdverse events and drug-related adverse events
    Study

    n = 73

    Comparator
    Efinopegdutide 10 mg
    Outcome group
    Adverse events · Whole body
    Studied dose
    1 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    Slightly higher incidences of adverse events and drug-related adverse events were observed in the efinopegdutide group compared with the semaglutide group, primarily related to an imbalance in gastrointestinal adverse events.
    1 context sentence
    Summary · context
    Participants with an LFC of ≥10% at screening were randomized 1:1 to efinopegdutide 10 mg or semaglutide 1 mg, both administered subcutaneously once weekly for 24 weeks.
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with non-alcoholic fatty liver disease, gastrointestinal adverse events were less frequent with semaglutide than with efinopegdutide.

    In plain wordsIn adults with fatty liver disease, semaglutide caused fewer stomach and gut side effects than efinopegdutide.

    Peptide
    Semaglutide
    Outcome
    DecreaseGastrointestinal adverse events
    Study

    n = 73

    Comparator
    Efinopegdutide 10 mg
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1 mg once weekly · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    primarily related to an imbalance in gastrointestinal adverse events.
    1 context sentence
    Summary · context
    Participants with an LFC of ≥10% at screening were randomized 1:1 to efinopegdutide 10 mg or semaglutide 1 mg, both administered subcutaneously once weekly for 24 weeks.

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 postedNCT04944992

A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

Merck Sharp & Dohme LLCn = 1454 Aug 2021 to 19 Oct 2022

Nonalcoholic Fatty Liver Disease · Nonalcoholic Steatohepatitis

Trial pageClinicalTrials.govUpdated 15 Nov 2023

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

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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