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Study · Randomized controlled trial · n = 71 · 2023

9 results

Semaglutide 2·4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial.

Loomba R, Abdelmalek MF, Armstrong MJ, Jara M, Kjær MS, Krarup N, Lawitz E, Ratziu V, Sanyal AJ, Schattenberg JM, Newsome PN

The lancet. Gastroenterology & hepatology16 Mar 2023Cited by 429 (Europe PMC)

PMID36934740 (opens in a new tab)PMCIDPMC10792518 (opens in a new tab)DOI10.1016/s2468-1253(23)00068-7 (opens in a new tab)PepBankPUB-36934740
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with NASH-related cirrhosis, semaglutide 2.4 mg did not significantly improve liver fibrosis by one stage or more without worsening of NASH versus placebo (11% vs 29%).

    In plain wordsIn adults with NASH-related cirrhosis, semaglutide did not improve liver scarring significantly more than placebo after 48 weeks.

    Peptide
    Semaglutide
    Outcome
    No significant changeImprovement in liver fibrosis of one stage or more without worsening of NASH at 48 weeks
    Study

    n = 71

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).

    Measurements

    Proportion with fibrosis improvement
    11%
    semaglutide
    Proportion with fibrosis improvement
    29%
    placebo

    Source sentences

    Summary
    After 48 weeks, there was no statistically significant difference between the two groups in the proportion of patients with an improvement in liver fibrosis of one stage or more without worsening of NASH (five [11%] of 47 patients in the semaglutide group vs seven [29%] of 24 in the placebo group; o…
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with NASH-related cirrhosis, semaglutide 2.4 mg did not significantly change the proportion achieving NASH resolution versus placebo.

    In plain wordsIn adults with NASH-related cirrhosis, semaglutide did not lead to NASH resolution significantly more often than placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changeNASH resolution
    Study

    n = 71

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    2.4 mg once weekly · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    There was also no significant difference between groups in the proportion of patients who achieved NASH resolution (p=0·29).
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo.
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with NASH-related cirrhosis, similar proportions had adverse events with semaglutide 2.4 mg (89%) and placebo (79%).

    In plain wordsIn adults with NASH-related cirrhosis, side effects were reported in similar proportions with semaglutide and placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changeAny adverse events
    Study

    n = 71

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Proportion with adverse events
    89%
    semaglutide
    Proportion with adverse events
    79%
    placebo

    Source sentences

    Summary
    Similar proportions of patients in each group reported adverse events (42 [89%] patients in the semaglutide group vs 19 [79%] in the placebo group)
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo.
  4. 04HumanRandomized controlled trialSafety outcome

    In adults with NASH-related cirrhosis, similar proportions had serious adverse events with semaglutide 2.4 mg (13%) and placebo (8%).

    In plain wordsIn adults with NASH-related cirrhosis, serious side effects were reported in similar proportions with semaglutide and placebo.

    Peptide
    Semaglutide
    Outcome
    No significant changeSerious adverse events
    Study

    n = 71

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Proportion with serious adverse events
    13%
    semaglutide
    Proportion with serious adverse events
    8%
    placebo

    Source sentences

    Summary
    Similar proportions of patients in each group reported adverse events (42 [89%] patients in the semaglutide group vs 19 [79%] in the placebo group) and serious adverse events (six [13%] vs two [8%])
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo.
  5. 05HumanRandomized controlled trialSafety outcome

    In adults with NASH-related cirrhosis, nausea was reported by 45% with semaglutide 2.4 mg versus 17% with placebo.

    In plain wordsIn adults with NASH-related cirrhosis, nausea was reported more often with semaglutide (45%) than with placebo (17%).

    Peptide
    Semaglutide
    Outcome
    IncreaseNausea
    Study

    n = 71

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Proportion with nausea
    45%
    semaglutide
    Proportion with nausea
    17%
    placebo

    Source sentences

    Summary
    nausea (21 [45%] vs four [17%])
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo.
  6. 06HumanRandomized controlled trialSafety outcome

    In adults with NASH-related cirrhosis, diarrhoea was reported by 19% with semaglutide 2.4 mg versus 8% with placebo.

    In plain wordsIn adults with NASH-related cirrhosis, diarrhoea was reported more often with semaglutide (19%) than with placebo (8%).

    Peptide
    Semaglutide
    Outcome
    IncreaseDiarrhoea
    Study

    n = 71

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Proportion with diarrhoea
    19%
    semaglutide
    Proportion with diarrhoea
    8%
    placebo

    Source sentences

    Summary
    diarrhoea (nine [19%] vs two [8%])
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo.
  7. 07HumanRandomized controlled trialSafety outcome

    In adults with NASH-related cirrhosis, vomiting was reported by 17% with semaglutide 2.4 mg and by none with placebo.

    In plain wordsIn adults with NASH-related cirrhosis, vomiting was reported with semaglutide (17%) but not with placebo.

    Peptide
    Semaglutide
    Outcome
    IncreaseVomiting
    Study

    n = 71

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Measurements

    Proportion with vomiting
    17%
    semaglutide

    Source sentences

    Summary
    vomiting (eight [17%] vs none
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo.
  8. 08HumanRandomized controlled trialSafety outcome

    In adults with NASH-related cirrhosis, hepatic and renal function remained stable on semaglutide 2.4 mg.

    In plain wordsIn adults with NASH-related cirrhosis, liver and kidney function stayed stable during semaglutide treatment.

    Peptide
    Semaglutide
    Outcome
    No significant changeHepatic and renal function
    Study

    n = 71

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Hepatic and renal function remained stable.
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually matching placebo.
  9. 09HumanRandomized controlled trialSafety outcome

    In adults with NASH-related cirrhosis, there were no decompensating events or deaths.

    In plain wordsIn adults with NASH-related cirrhosis, no decompensating events or deaths occurred in the trial.

    Peptide
    Semaglutide
    Outcome
    No significant changeDecompensating events and deaths
    Study

    n = 71

    Outcome group
    Mortality · Liver
    Studied dose
    2.4 mg once weekly · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    There were no decompensating events or deaths.
    1 context sentence
    Summary · context
    Adults with biopsy-confirmed NASH-related cirrhosis and body-mass index (BMI) of 27 kg/m2 or more were randomly assigned (2:1) to receive either once-weekly subcutaneous semaglutide 2·4 mg or visually 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 postedNCT03987451

A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

Novo Nordisk A/Sn = 7118 Jun 2019 to 10 Jun 2021

Non-alcoholic Steatohepatitis

Trial pageClinicalTrials.govUpdated 29 May 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

    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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