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Study · Randomized controlled trial · 2024

4 results

Artificial intelligence scoring of liver biopsies in a phase II trial of semaglutide in nonalcoholic steatohepatitis.

Ratziu V, Francque S, Behling CA, Cejvanovic V, Cortez-Pinto H, Iyer JS, Krarup N, Le Q, Sejling AS, Tiniakos D, Harrison SA

Hepatology (Baltimore, Md.)19 Dec 2023Cited by 34 (Europe PMC)

PMID38112484 (opens in a new tab)PMCIDPMC11185915 (opens in a new tab)DOI10.1097/hep.0000000000000723 (opens in a new tab)PepBankPUB-38112484
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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 NASH and fibrosis F1-F3, semaglutide 0.4 mg led to NASH resolution without worsening fibrosis in 58.5% versus 22.0% with placebo by pathologist reading.

    In plain wordsIn adults with NASH, more people on semaglutide 0.4 mg than on placebo had NASH resolve without worse scarring by pathologist reading.

    Peptide
    Semaglutide
    Outcome
    IncreaseNASH resolution without worsening of fibrosis (pathologist reading)
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    NASH resolution
    58.5%
    semaglutide 0.4 mg, pathologist
    NASH resolution
    22%
    placebo, pathologist

    Source sentences

    Summary
    Pathologist and ML-derived categorical assessments detected a significantly greater percentage of patients achieving the primary endpoint of NASH resolution without worsening of fibrosis with semaglutide 0.4 mg versus placebo (pathologist 58.5% vs. 22.0%, p < 0.0001
    1 context sentence
    Summary · context
    This post hoc analysis included data from a subset of patients (n=251) with biopsy-confirmed NASH and fibrosis stage F1-F3 from a 72-week randomized placebo-controlled trial of once-daily subcutaneous semaglutide 0.1, 0.2, or 0.4 mg (NCT02970942).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with NASH and fibrosis F1-F3, semaglutide 0.4 mg led to NASH resolution without worsening fibrosis in 36.9% versus 11.9% with placebo by machine-learning categorical reading.

    In plain wordsIn adults with NASH, more people on semaglutide 0.4 mg than on placebo had NASH resolve without worse scarring by machine-learning reading.

    Peptide
    Semaglutide
    Outcome
    IncreaseNASH resolution without worsening of fibrosis (machine-learning reading)
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    NASH resolution
    36.9%
    semaglutide 0.4 mg, ML
    NASH resolution
    11.9%
    placebo, ML

    Source sentences

    Summary
    Pathologist and ML-derived categorical assessments detected a significantly greater percentage of patients achieving the primary endpoint of NASH resolution without worsening of fibrosis with semaglutide 0.4 mg versus placebo (pathologist 58.5% vs. 22.0%, p < 0.0001; ML 36.9% vs. 11.9%; p =0.0015)
    1 context sentence
    Summary · context
    This post hoc analysis included data from a subset of patients (n=251) with biopsy-confirmed NASH and fibrosis stage F1-F3 from a 72-week randomized placebo-controlled trial of once-daily subcutaneous semaglutide 0.1, 0.2, or 0.4 mg (NCT02970942).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with NASH and fibrosis F1-F3, semaglutide 0.4 mg gave a higher but nonsignificant share with fibrosis improvement without NASH worsening versus placebo, by both reading methods.

    In plain wordsIn adults with NASH, fibrosis improved in more people on semaglutide 0.4 mg than on placebo, but the difference was not statistically significant.

    Peptide
    Semaglutide
    Outcome
    No significant changeLiver fibrosis improvement without NASH worsening
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Source sentences

    Summary
    Both methods detected a higher but nonsignificant percentage of patients on semaglutide 0.4 mg versus placebo achieving the secondary endpoint of liver fibrosis improvement without NASH worsening.
    1 context sentence
    Summary · context
    This post hoc analysis included data from a subset of patients (n=251) with biopsy-confirmed NASH and fibrosis stage F1-F3 from a 72-week randomized placebo-controlled trial of once-daily subcutaneous semaglutide 0.1, 0.2, or 0.4 mg (NCT02970942).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with NASH and fibrosis F1-F3, the machine-learning continuous score showed a significant reduction in fibrosis with semaglutide 0.4 mg versus placebo.

    In plain wordsIn adults with NASH, a machine-learning score found less liver scarring with semaglutide 0.4 mg than with placebo.

    Peptide
    Semaglutide
    Outcome
    DecreaseFibrosis reduction by machine-learning continuous score
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Source sentences

    Summary
    a quantitative reduction in fibrosis with semaglutide 0.4 mg versus placebo ( p =0.0099)
    1 context sentence
    Summary · context
    This post hoc analysis included data from a subset of patients (n=251) with biopsy-confirmed NASH and fibrosis stage F1-F3 from a 72-week randomized placebo-controlled trial of once-daily subcutaneous semaglutide 0.1, 0.2, or 0.4 mg (NCT02970942).

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 postedNCT02970942

Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Novo Nordisk A/Sn = 32030 Nov 2016 to 19 Mar 2020

Hepatobiliary Disorders · Non-alcoholic Steatohepatitis

Trial pageClinicalTrials.govUpdated 16 Nov 2021

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, 00:04 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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