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Study · Randomized controlled trial · n = 170 · 2026

6 results

Weight reduction-dependent/-independent effects of survodutide on liver endpoints: Mediation analysis of a phase 2 trial in MASH.

Noureddin M, Sanyal AJ, Bedossa P, Fraessdorf M, Schoelch C, Startseva E, Marshall SR, Marshall SR, Alhussein A, Neff GW, Lawitz EJ, Lawitz EJ and 8 more

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Bugianesi E, Anstee QM, Newsome PN, Ratziu V, Hosseini-Tabatabaei A, Schattenberg JM, Alkhouri N, Younes R

Hepatology (Baltimore, Md.)3 Aug 2026

PMID42545725 (opens in a new tab)DOI10.1097/hep.0000000000001825 (opens in a new tab)PepBankPUB-42545725
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 trialMechanism

    In adults with MASH and fibrosis stages F2-F3, weight reduction mediated an estimated 66.7% of the total survodutide effect on resolution of MASH without worsening of fibrosis.

    In plain wordsIn adults with MASH, about two thirds of survodutide's effect on MASH resolution was explained by weight loss.

    Peptide
    Survodutide
    Outcome
    Not applicableShare of effect on MASH resolution mediated by weight reduction
    Study

    n = 170

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Measurements

    Proportion of total effect mediated by weight reduction
    66.7%
    resolution of MASH without worsening of fibrosis

    Source sentences

    Summary
    the percentage of the total treatment effect mediated by weight reduction (indirect effect) was estimated at
    3 context sentences
    Summary · context
    66.7% for resolution of MASH without worsening of fibrosis
    Summary · context
    Data were included for participants with fibrosis stages F2-F3 and paired baseline/end-of-treatment biopsy readings; survodutide dose arms were pooled.
    Summary · context
    This analysis included 170 participants.
  2. 02HumanRandomized controlled trialMechanism

    In adults with MASH and fibrosis stages F2-F3, weight reduction mediated an estimated 71.8% of the total survodutide effect on improvement in MASH without worsening of fibrosis.

    In plain wordsIn adults with MASH, about 71.8% of survodutide's effect on MASH improvement was explained by weight loss.

    Peptide
    Survodutide
    Outcome
    Not applicableShare of effect on MASH improvement mediated by weight reduction
    Study

    n = 170

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Measurements

    Proportion of total effect mediated by weight reduction
    71.8%
    improvement in MASH without worsening of fibrosis

    Source sentences

    Summary
    the percentage of the total treatment effect mediated by weight reduction (indirect effect) was estimated at
    3 context sentences
    Summary · context
    71.8% for improvement in MASH without worsening of fibrosis
    Summary · context
    Data were included for participants with fibrosis stages F2-F3 and paired baseline/end-of-treatment biopsy readings; survodutide dose arms were pooled.
    Summary · context
    This analysis included 170 participants.
  3. 03HumanRandomized controlled trialMechanism

    In adults with MASH and fibrosis stages F2-F3, weight reduction mediated an estimated 36.3% of the total survodutide effect on improvement in fibrosis without worsening of MASH, which suggests a greater direct effect.

    In plain wordsIn adults with MASH, about 36.3% of survodutide's effect on liver scarring was explained by weight loss; most was a direct effect.

    Peptide
    Survodutide
    Outcome
    Not applicableShare of effect on fibrosis improvement mediated by weight reduction
    Study

    n = 170

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Measurements

    Proportion of total effect mediated by weight reduction
    36.3%
    improvement in fibrosis without worsening of MASH

    Source sentences

    Summary
    the percentage of the total treatment effect mediated by weight reduction (indirect effect) was estimated at
    3 context sentences
    Summary · context
    36.3% for improvement in fibrosis without worsening of MASH (suggesting a greater direct effect)
    Summary · context
    Data were included for participants with fibrosis stages F2-F3 and paired baseline/end-of-treatment biopsy readings; survodutide dose arms were pooled.
    Summary · context
    This analysis included 170 participants.
  4. 04HumanRandomized controlled trialMechanism

    In adults with MASH and fibrosis stages F2-F3, less than 50% of the total survodutide effect on non-invasive tests of inflammation and fibrosis was mediated by weight reduction (16.5% for AST to 38.6% for Enhanced Liver Fibrosis).

    In plain wordsIn adults with MASH, weight loss explained less than half of survodutide's effect on blood tests of liver inflammation and scarring.

    Peptide
    Survodutide
    Outcome
    Not applicableShare of effect on inflammation and fibrosis tests mediated by weight reduction
    Study

    n = 170

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Measurements

    Proportion of total effect mediated by weight reduction
    < 50%
    NITs of inflammation and fibrosis
    Proportion of total effect mediated by weight reduction
    16.5%
    AST
    Proportion of total effect mediated by weight reduction
    38.6%
    Enhanced Liver Fibrosis

    Source sentences

    Summary
    Similarly, for NITs related to inflammation/fibrosis, <50% of the total effect was mediated by weight reduction [16.5% (AST)-38.6% (Enhanced Liver Fibrosis)].
    2 context sentences
    Summary · context
    Data were included for participants with fibrosis stages F2-F3 and paired baseline/end-of-treatment biopsy readings; survodutide dose arms were pooled.
    Summary · context
    This analysis included 170 participants.
  5. 05HumanRandomized controlled trialMechanism

    In adults with MASH and fibrosis stages F2-F3, weight reduction mediated an estimated 58.2% of the total survodutide effect on MRI-proton density fat fraction.

    In plain wordsIn adults with MASH, about 58.2% of survodutide's effect on liver fat seen on MRI was explained by weight loss.

    Peptide
    Survodutide
    Outcome
    Not applicableShare of effect on MRI-PDFF mediated by weight reduction
    Study

    n = 170

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Measurements

    Proportion of total effect mediated by weight reduction
    58.2%
    MRI-proton density fat fraction

    Source sentences

    Summary
    For steatosis-related endpoints (MRI-proton density fat fraction and FibroScan Controlled Attenuation Parameter), a higher proportion was mediated by weight reduction (58.2% and 77.4%, respectively).
    2 context sentences
    Summary · context
    Data were included for participants with fibrosis stages F2-F3 and paired baseline/end-of-treatment biopsy readings; survodutide dose arms were pooled.
    Summary · context
    This analysis included 170 participants.
  6. 06HumanRandomized controlled trialMechanism

    In adults with MASH and fibrosis stages F2-F3, weight reduction mediated an estimated 77.4% of the total survodutide effect on FibroScan Controlled Attenuation Parameter.

    In plain wordsIn adults with MASH, about 77.4% of survodutide's effect on a FibroScan liver fat measure was explained by weight loss.

    Peptide
    Survodutide
    Outcome
    Not applicableShare of effect on FibroScan CAP mediated by weight reduction
    Study

    n = 170

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    Dose not stated · 48 weeksAs given in this study (human).

    Measurements

    Proportion of total effect mediated by weight reduction
    77.4%
    FibroScan Controlled Attenuation Parameter

    Source sentences

    Summary
    For steatosis-related endpoints (MRI-proton density fat fraction and FibroScan Controlled Attenuation Parameter), a higher proportion was mediated by weight reduction (58.2% and 77.4%, respectively).
    2 context sentences
    Summary · context
    Data were included for participants with fibrosis stages F2-F3 and paired baseline/end-of-treatment biopsy readings; survodutide dose arms were pooled.
    Summary · context
    This analysis included 170 participants.

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

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

    9 Oct 2026, 19:08 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

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