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Study · Randomized controlled trial · n = 320 · 2023

8 results

Improved health-related quality of life with semaglutide in people with non-alcoholic steatohepatitis: A randomised trial.

Romero-Gómez M, Armstrong MJ, Funuyet-Salas J, Mangla KK, Ladelund S, Sejling AS, Shrestha I, Sanyal AJ

Alimentary pharmacology & therapeutics16 Jun 2023Cited by 23 (Europe PMC)

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. Results still quote short attributed sentences.

Results from this study8

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with biopsy-proven NASH, semaglutide improved the SF-36 physical component summary score versus placebo at 72 weeks (ETD 4.26).

    In plain wordsIn adults with NASH, semaglutide improved the physical part of quality of life more than placebo.

    Outcome
    IncreaseSF-36 physical component summary score at 72 weeks
    Study

    n = 320

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    4.26 score points
    PCS

    Source sentences

    Summary
    At 72 weeks, semaglutide was associated with significant improvements in physical component summary (PCS) score (estimated treatment difference [ETD] 4.26; 95% confidence interval [CI]: 1.96-6.55; p = 0.0003)
    2 context sentences
    Summary · context
    Adults with biopsy-proven NASH and stage 1-3 fibrosis were randomised (3:3:3:1:1:1) to once-daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks.
    Summary · context
    Patients were invited to complete the Short Form-36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with biopsy-proven NASH, semaglutide improved the SF-36 bodily pain score versus placebo at 72 weeks (ETD 5.07).

    In plain wordsIn adults with NASH, semaglutide improved the bodily pain score more than placebo.

    Outcome
    IncreaseSF-36 bodily pain at 72 weeks
    Study

    n = 320

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    5.07 score points
    bodily pain

    Source sentences

    Summary
    bodily pain (ETD 5.07; 95% CI: 2.15-7.99; p = 0.0007)
    2 context sentences
    Summary · context
    Adults with biopsy-proven NASH and stage 1-3 fibrosis were randomised (3:3:3:1:1:1) to once-daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks.
    Summary · context
    Patients were invited to complete the Short Form-36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with biopsy-proven NASH, semaglutide improved SF-36 physical functioning versus placebo at 72 weeks (ETD 3.51).

    In plain wordsIn adults with NASH, semaglutide improved physical functioning more than placebo.

    Outcome
    IncreaseSF-36 physical functioning at 72 weeks
    Study

    n = 320

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    3.51 score points
    physical functioning

    Source sentences

    Summary
    physical functioning (ETD 3.51; 95% CI: 1.16-5.86; p = 0.0034)
    2 context sentences
    Summary · context
    Adults with biopsy-proven NASH and stage 1-3 fibrosis were randomised (3:3:3:1:1:1) to once-daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks.
    Summary · context
    Patients were invited to complete the Short Form-36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with biopsy-proven NASH, semaglutide improved the SF-36 score for role limitations due to physical health problems versus placebo at 72 weeks (ETD 2.80).

    In plain wordsIn adults with NASH, semaglutide reduced physical health limits on daily roles more than placebo.

    Outcome
    IncreaseSF-36 role limitations due to physical health at 72 weeks
    Study

    n = 320

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    2.8 score points
    role limitations physical

    Source sentences

    Summary
    role limitations due to physical health problems (ETD 2.80; 95% CI: 0.28-5.33; p = 0.0294)
    2 context sentences
    Summary · context
    Adults with biopsy-proven NASH and stage 1-3 fibrosis were randomised (3:3:3:1:1:1) to once-daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks.
    Summary · context
    Patients were invited to complete the Short Form-36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with biopsy-proven NASH, semaglutide improved SF-36 social functioning versus placebo at 72 weeks (ETD 3.16).

    In plain wordsIn adults with NASH, semaglutide improved social functioning more than placebo.

    Outcome
    IncreaseSF-36 social functioning at 72 weeks
    Study

    n = 320

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    3.16 score points
    social functioning

    Source sentences

    Summary
    social functioning (ETD 3.16; 95% CI: 0.53-5.78; p = 0.0183)
    2 context sentences
    Summary · context
    Adults with biopsy-proven NASH and stage 1-3 fibrosis were randomised (3:3:3:1:1:1) to once-daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks.
    Summary · context
    Patients were invited to complete the Short Form-36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with biopsy-proven NASH, semaglutide improved SF-36 vitality versus placebo at 72 weeks (ETD 4.47).

    In plain wordsIn adults with NASH, semaglutide improved vitality more than placebo.

    Outcome
    IncreaseSF-36 vitality at 72 weeks
    Study

    n = 320

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    4.47 score points
    vitality

    Source sentences

    Summary
    vitality (ETD 4.47; 95% CI: 1.63-7.32; p = 0.0021)
    2 context sentences
    Summary · context
    Adults with biopsy-proven NASH and stage 1-3 fibrosis were randomised (3:3:3:1:1:1) to once-daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks.
    Summary · context
    Patients were invited to complete the Short Form-36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults with biopsy-proven NASH, the SF-36 mental component summary score did not differ significantly between semaglutide and placebo (ETD 1.02).

    In plain wordsIn adults with NASH, semaglutide did not change the mental part of quality of life compared with placebo.

    Outcome
    No significant changeSF-36 mental component summary score at 72 weeks
    Study

    n = 320

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.1, 0.2 or 0.4 mg once daily · subcutaneous · 72 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    1.02 score points
    MCS

    Source sentences

    Summary
    There was no significant difference in the mental component summary score (ETD 1.02; 95% CI: -1.59 to 3.62; p = 0.4441).
    2 context sentences
    Summary · context
    Adults with biopsy-proven NASH and stage 1-3 fibrosis were randomised (3:3:3:1:1:1) to once-daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks.
    Summary · context
    Patients were invited to complete the Short Form-36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.

Studies that did not test the peptide alone1

In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Semaglutide.

  1. 08HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome

    In adults with NASH, physical component summary improvements were greater in patients with NASH resolution than without, pooling semaglutide and placebo.

    In plain wordsIn adults with NASH, physical quality of life improved more in people whose NASH resolved, whether they took semaglutide or placebo.

    Outcome
    IncreasePhysical component summary improvement by NASH resolution
    Study

    n = 320

    Comparator
    Patients without NASH resolution
    Analysis
    Secondary
    Outcome group
    Quality of life · Whole body

    Source sentences

    Summary
    After 72 weeks, improvements in PCS scores were significantly greater in patients (pooled semaglutide and placebo) with NASH resolution than without (p = 0.014).
    2 context sentences
    Summary · context
    Adults with biopsy-proven NASH and stage 1-3 fibrosis were randomised (3:3:3:1:1:1) to once-daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks.
    Summary · context
    Patients were invited to complete the Short Form-36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.

    In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.

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, 00:50 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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