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Study · Randomized controlled trial · n = 171 · 2025

8 results

Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study.

Noureddin M, Harrison SA, Loomba R, Alkhouri N, Chalasani N, Sheikh MY, Tomah S, Gutierrez JA, Urbina S, Suschak JJ, Brown R, Odili O and 7 more

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Yang J, Keeton S, Neff G, Mena E, Roberts MS, Browne SK, Harris MS

Lancet (London, England)11 Nov 2025Cited by 29 (Europe PMC)

PMID41237796 (opens in a new tab)DOI10.1016/s0140-6736(25)02114-2 (opens in a new tab)PepBankPUB-41237796
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: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In MASH, resolution without fibrosis worsening occurred in 52% with pemvidutide 1·8 mg versus 20% with placebo.

    In plain wordsIn MASH, pemvidutide increased disease resolution without worsening fibrosis compared with placebo.

    Peptide
    Pemvidutide
    Outcome
    IncreaseMASH resolution without fibrosis worsening
    Study

    n = 171

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1·8 mg · subcutaneous once weekly · 24 weeksAs given in this study (human).

    Measurements

    MASH resolution without fibrosis worsening
    52%
    pemvidutide 1.8 mg, week 24
    MASH resolution without fibrosis worsening
    20%
    placebo, week 24
    Difference versus placebo
    32%
    pemvidutide 1.8 mg, week 24

    Source sentences

    Summary
    MASH resolution without fibrosis worsening was observed in 18 (20%) of 86 patients in the placebo group, 24 (58%) of 41 patients in the 1·2 mg pemvidutide group (difference of 38% [95% CI 21-56]; p<0·0001), and 45 (52%) of 85 patients in the 1·8 mg pemvidutide group (difference of 32% [95% CI 19-46]; p<0·0001).
    2 context sentences
    Summary · context
    IMPACT is an ongoing 48-week international, randomised, double-blind, placebo-controlled, phase 2b trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3.
    Summary · context
    Patients from 83 sites in the USA and Australia were randomly assigned 1:2:2 to receive once-weekly subcutaneous pemvidutide (1·2 mg or 1·8 mg), administered without dose titration, or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In MASH, fibrosis improvement without MASH worsening did not significantly differ between pemvidutide 1·8 mg and placebo.

    In plain wordsIn MASH, pemvidutide did not significantly improve fibrosis without disease worsening compared with placebo.

    Peptide
    Pemvidutide
    Outcome
    No significant changeFibrosis improvement without MASH worsening
    Study

    n = 171

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1·8 mg · subcutaneous once weekly · 24 weeksAs given in this study (human).

    Measurements

    Fibrosis improvement without MASH worsening
    36%
    pemvidutide 1·8 mg (30 of 85)
    Fibrosis improvement without MASH worsening
    28%
    placebo (24 of 86)
    Difference versus placebo
    8%
    pemvidutide 1·8 mg
    95% CI of difference
    −6 to 22%
    pemvidutide 1·8 mg

    Source sentences

    Summary
    Fibrosis improvement without worsening of MASH was observed in 24 (28%) of 86 patients in the placebo group, 13 (33%) of 41 patients in the 1·2 mg pemvidutide group (difference of 5% [95% CI -13 to 22]; p=0·59), and 30 (36%) of 85 patients in the 1·8 mg pemvidutide group (difference of 8% [95% CI -6 to 22]; p=0·27).
    2 context sentences
    Summary · context
    IMPACT is an ongoing 48-week international, randomised, double-blind, placebo-controlled, phase 2b trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3.
    Summary · context
    Patients from 83 sites in the USA and Australia were randomly assigned 1:2:2 to receive once-weekly subcutaneous pemvidutide (1·2 mg or 1·8 mg), administered without dose titration, or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In MASH, resolution without fibrosis worsening occurred in 58% with pemvidutide 1·2 mg versus 20% with placebo.

    In plain wordsIn MASH, pemvidutide increased disease resolution without worsening fibrosis compared with placebo.

    Peptide
    Pemvidutide
    Outcome
    IncreaseMASH resolution without fibrosis worsening
    Study

    n = 127

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1·2 mg · subcutaneous once weekly · 24 weeksAs given in this study (human).

    Measurements

    MASH resolution without fibrosis worsening
    58%
    pemvidutide 1.2 mg, week 24
    MASH resolution without fibrosis worsening
    20%
    placebo, week 24
    Difference versus placebo
    38%
    pemvidutide 1.2 mg, week 24

    Source sentences

    Summary
    MASH resolution without fibrosis worsening was observed in 18 (20%) of 86 patients in the placebo group, 24 (58%) of 41 patients in the 1·2 mg pemvidutide group (difference of 38% [95% CI 21-56]; p<0·0001), and 45 (52%) of 85 patients in the 1·8 mg pemvidutide group (difference of 32% [95% CI 19-46]; p<0·0001).
    2 context sentences
    Summary · context
    IMPACT is an ongoing 48-week international, randomised, double-blind, placebo-controlled, phase 2b trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3.
    Summary · context
    Patients from 83 sites in the USA and Australia were randomly assigned 1:2:2 to receive once-weekly subcutaneous pemvidutide (1·2 mg or 1·8 mg), administered without dose titration, or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In MASH, fibrosis improvement without MASH worsening did not significantly differ between pemvidutide 1·2 mg and placebo.

    In plain wordsIn MASH, pemvidutide did not significantly improve fibrosis without disease worsening compared with placebo.

    Peptide
    Pemvidutide
    Outcome
    No significant changeFibrosis improvement without MASH worsening
    Study

    n = 127

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1·2 mg · subcutaneous once weekly · 24 weeksAs given in this study (human).

    Measurements

    Fibrosis improvement without MASH worsening
    33%
    pemvidutide 1.2 mg, week 24
    Fibrosis improvement without MASH worsening
    28%
    placebo, week 24
    Difference versus placebo
    5%
    pemvidutide 1.2 mg, week 24

    Source sentences

    Summary
    Fibrosis improvement without worsening of MASH was observed in 24 (28%) of 86 patients in the placebo group, 13 (33%) of 41 patients in the 1·2 mg pemvidutide group (difference of 5% [95% CI -13 to 22]; p=0·59), and 30 (36%) of 85 patients in the 1·8 mg pemvidutide group (difference of 8% [95% CI -6 to 22]; p=0·27).
    2 context sentences
    Summary · context
    IMPACT is an ongoing 48-week international, randomised, double-blind, placebo-controlled, phase 2b trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3.
    Summary · context
    Patients from 83 sites in the USA and Australia were randomly assigned 1:2:2 to receive once-weekly subcutaneous pemvidutide (1·2 mg or 1·8 mg), administered without dose titration, or placebo.
  5. 05HumanRandomized controlled trialSafety outcome

    In MASH, adverse events occurred in 81% with pemvidutide 1·8 mg versus 67% with placebo, mostly mild or moderate.

    In plain wordsIn MASH, adverse events were more frequent with pemvidutide than placebo, mostly mild or moderate.

    Peptide
    Pemvidutide
    Outcome
    IncreaseAdverse events
    Study

    n = 171

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1·8 mg · subcutaneous once weekly · 24 weeksAs given in this study (human).

    Measurements

    Adverse events incidence
    81%
    pemvidutide 1·8 mg (69 of 85)
    Adverse events incidence
    67%
    placebo (58 of 86)

    Source sentences

    Summary
    Adverse events were reported in 32 (78%) of 41 patients receiving 1·2 mg pemvidutide, 69 (81%) of 85 patients receiving 1·8 mg pemvidutide, and 58 (67%) of 86 patients receiving placebo, the majority of which were mild or moderate in severity.
    2 context sentences
    Summary · context
    IMPACT is an ongoing 48-week international, randomised, double-blind, placebo-controlled, phase 2b trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3.
    Summary · context
    Patients from 83 sites in the USA and Australia were randomly assigned 1:2:2 to receive once-weekly subcutaneous pemvidutide (1·2 mg or 1·8 mg), administered without dose titration, or placebo.
  6. 06HumanRandomized controlled trialSafety outcome

    In MASH, adverse-event discontinuations occurred in 1% with pemvidutide 1·8 mg versus 2% with placebo.

    In plain wordsIn MASH, adverse-event discontinuations were less frequent with pemvidutide than placebo.

    Peptide
    Pemvidutide
    Outcome
    DecreaseDiscontinuations due to adverse events
    Study

    n = 171

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1·8 mg · subcutaneous once weekly · 24 weeksAs given in this study (human).

    Measurements

    Discontinuations due to adverse events
    1%
    pemvidutide 1·8 mg (1 of 85)
    Discontinuations due to adverse events
    2%
    placebo (2 of 86)

    Source sentences

    Summary
    Pemvidutide was well tolerated, with discontinuations due to adverse events in none of 41 patients in the 1·2 mg pemvidutide group, one (1%) of 85 patients in the 1·8 mg pemvidutide group, and two (2%) of 86 patients in the placebo group.
    2 context sentences
    Summary · context
    IMPACT is an ongoing 48-week international, randomised, double-blind, placebo-controlled, phase 2b trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3.
    Summary · context
    Patients from 83 sites in the USA and Australia were randomly assigned 1:2:2 to receive once-weekly subcutaneous pemvidutide (1·2 mg or 1·8 mg), administered without dose titration, or placebo.
  7. 07HumanRandomized controlled trialSafety outcome

    In MASH, adverse events occurred in 78% with pemvidutide 1·2 mg versus 67% with placebo, mostly mild or moderate.

    In plain wordsIn MASH, adverse events were more frequent with pemvidutide than placebo, mostly mild or moderate.

    Peptide
    Pemvidutide
    Outcome
    IncreaseAdverse events
    Study

    n = 127

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1·2 mg · subcutaneous once weekly · 24 weeksAs given in this study (human).

    Measurements

    Adverse events incidence
    78%
    pemvidutide 1·2 mg (32 of 41)
    Adverse events incidence
    67%
    placebo (58 of 86)

    Source sentences

    Summary
    Adverse events were reported in 32 (78%) of 41 patients receiving 1·2 mg pemvidutide, 69 (81%) of 85 patients receiving 1·8 mg pemvidutide, and 58 (67%) of 86 patients receiving placebo, the majority of which were mild or moderate in severity.
    2 context sentences
    Summary · context
    IMPACT is an ongoing 48-week international, randomised, double-blind, placebo-controlled, phase 2b trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3.
    Summary · context
    Patients from 83 sites in the USA and Australia were randomly assigned 1:2:2 to receive once-weekly subcutaneous pemvidutide (1·2 mg or 1·8 mg), administered without dose titration, or placebo.
  8. 08HumanRandomized controlled trialSafety outcome

    In MASH, adverse-event discontinuations occurred in none with pemvidutide 1·2 mg versus 2% with placebo.

    In plain wordsIn MASH, adverse-event discontinuations were less frequent with pemvidutide than placebo.

    Peptide
    Pemvidutide
    Outcome
    DecreaseDiscontinuations due to adverse events
    Study

    n = 127

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1·2 mg · subcutaneous once weekly · 24 weeksAs given in this study (human).

    Measurements

    Discontinuations due to adverse events
    2%
    placebo (2 of 86)

    Source sentences

    Summary
    Pemvidutide was well tolerated, with discontinuations due to adverse events in none of 41 patients in the 1·2 mg pemvidutide group, one (1%) of 85 patients in the 1·8 mg pemvidutide group, and two (2%) of 86 patients in the placebo group.
    2 context sentences
    Summary · context
    IMPACT is an ongoing 48-week international, randomised, double-blind, placebo-controlled, phase 2b trial in patients with biopsy-confirmed MASH and fibrosis stage F2 or F3.
    Summary · context
    Patients from 83 sites in the USA and Australia were randomly assigned 1:2:2 to receive once-weekly subcutaneous pemvidutide (1·2 mg or 1·8 mg), administered without dose titration, or 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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT05989711

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)

Altimmune, Inc.n = 21227 Jul 2023 to 25 Nov 2025

Non-Alcoholic Steatohepatitis (NASH)

Trial pageClinicalTrials.govUpdated 18 May 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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