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Study · Randomized controlled trial · n = 21 · 2022

6 results

Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: A randomised, open-label phase II trial.

Alkhouri N, Herring R, Kabler H, Kayali Z, Hassanein T, Kohli A, Huss RS, Zhu Y, Billin AN, Damgaard LH, Buchholtz K, Kjær MS and 4 more

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Balendran C, Myers RP, Loomba R, Noureddin M

Journal of hepatology16 Apr 2022Cited by 195 (Europe PMC)

PMID35439567 (opens in a new tab)DOI10.1016/j.jhep.2022.04.003 (opens in a new tab)PepBankPUB-35439567
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

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with NASH, semaglutide 2.4 mg monotherapy reduced liver fat measured by MRI-PDFF by a least-squares mean of 8.0% (absolute change) over 24 weeks.

    In plain wordsIn people with NASH, semaglutide alone lowered liver fat over 24 weeks.

    Peptide
    Semaglutide
    Outcome
    DecreaseMRI-PDFF absolute change with semaglutide monotherapy
    Study

    n = 21

    Analysis
    Exploratory
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    2.4 mg once weekly · 24 weeksAs given in this study (human).

    Measurements

    MRI-PDFF absolute change
    −8%
    semaglutide monotherapy

    Source sentences

    Summary
    compared with semaglutide monotherapy, combinations resulted in greater improvements in liver steatosis measured by MRI-PDFF (least-squares mean of absolute changes: -9.8 to -11.0% vs. -8.0%)
    2 context sentences
    Summary · context
    This was a phase II, open-label, proof-of-concept trial in which patients with NASH (F2-F3 on biopsy, or MRI-proton density fat fraction [MRI-PDFF] ≥10% and liver stiffness by transient elastography ≥7 kPa) were randomised to 24 weeks' treatment with semaglutide 2.4 mg once weekly as monotherapy or…
    Summary · context
    A total of 108 patients were randomised to semaglutide (n = 21), semaglutide plus cilofexor 30 mg (n = 22), semaglutide plus cilofexor 100 mg (n = 22), semaglutide plus firsocostat (n = 22) or semaglutide, cilofexor 30 mg and firsocostat (n = 21).

Studies that did not test the peptide alone5

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. 02HumanNot a test of Semaglutide aloneRandomized controlled trialSafety outcome

    In patients with NASH, the incidence of adverse events was similar across semaglutide monotherapy and combination groups (73-90%), mostly gastrointestinal.

    In plain wordsIn people with NASH, side effects were similar across all treatment groups and mostly affected the gut.

    Peptide
    Semaglutide
    Outcome
    No significant changeIncidence of adverse events across treatment groups
    Study

    n = 108

    Comparator
    Between treatment groups
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body

    Measurements

    Adverse event incidence
    73 to 90%
    all groups

    Source sentences

    Summary
    Treatments were well tolerated - the incidence of adverse events was similar across groups (73-90%) and most events were gastrointestinal in nature.
    3 context sentences
    Summary · context
    The primary endpoint was safety.
    Summary · context
    This was a phase II, open-label, proof-of-concept trial in which patients with NASH (F2-F3 on biopsy, or MRI-proton density fat fraction [MRI-PDFF] ≥10% and liver stiffness by transient elastography ≥7 kPa) were randomised to 24 weeks' treatment with semaglutide 2.4 mg once weekly as monotherapy or…
    Summary · context
    A total of 108 patients were randomised to semaglutide (n = 21), semaglutide plus cilofexor 30 mg (n = 22), semaglutide plus cilofexor 100 mg (n = 22), semaglutide plus firsocostat (n = 22) or semaglutide, cilofexor 30 mg and firsocostat (n = 21).

    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.

  2. 03HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome

    In patients with NASH, weight loss was similar (7-10%) across semaglutide monotherapy and combination groups.

    In plain wordsIn people with NASH, weight loss was similar whether they took semaglutide alone or with other drugs.

    Peptide
    Semaglutide
    Outcome
    No significant changeWeight loss across treatment groups
    Study

    n = 108

    Comparator
    Between semaglutide alone and combinations
    Analysis
    Exploratory
    Outcome group
    Body weight · Metabolic and weight

    Measurements

    Weight loss
    7 to 10%
    all groups

    Source sentences

    Summary
    Despite similar weight loss (7-10%)
    2 context sentences
    Summary · context
    This was a phase II, open-label, proof-of-concept trial in which patients with NASH (F2-F3 on biopsy, or MRI-proton density fat fraction [MRI-PDFF] ≥10% and liver stiffness by transient elastography ≥7 kPa) were randomised to 24 weeks' treatment with semaglutide 2.4 mg once weekly as monotherapy or…
    Summary · context
    A total of 108 patients were randomised to semaglutide (n = 21), semaglutide plus cilofexor 30 mg (n = 22), semaglutide plus cilofexor 100 mg (n = 22), semaglutide plus firsocostat (n = 22) or semaglutide, cilofexor 30 mg and firsocostat (n = 21).

    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.

  3. 04HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome

    In patients with NASH, semaglutide combined with cilofexor and/or firsocostat reduced liver fat on MRI-PDFF more than semaglutide monotherapy (-9.8 to -11.0% versus -8.0%).

    In plain wordsIn people with NASH, semaglutide with cilofexor or firsocostat lowered liver fat more than semaglutide alone.

    Peptide
    Semaglutide
    Outcome
    DecreaseMRI-PDFF change with semaglutide plus cilofexor and/or firsocostat
    Study

    n: not reported in source

    Comparator
    Semaglutide monotherapy
    Analysis
    Exploratory
    Outcome group
    Liver fat and liver function · Liver

    Measurements

    MRI-PDFF absolute change
    −9.8 to −11%
    combinations

    Source sentences

    Summary
    compared with semaglutide monotherapy, combinations resulted in greater improvements in liver steatosis measured by MRI-PDFF (least-squares mean of absolute changes: -9.8 to -11.0% vs. -8.0%)
    2 context sentences
    Summary · context
    This was a phase II, open-label, proof-of-concept trial in which patients with NASH (F2-F3 on biopsy, or MRI-proton density fat fraction [MRI-PDFF] ≥10% and liver stiffness by transient elastography ≥7 kPa) were randomised to 24 weeks' treatment with semaglutide 2.4 mg once weekly as monotherapy or…
    Summary · context
    A total of 108 patients were randomised to semaglutide (n = 21), semaglutide plus cilofexor 30 mg (n = 22), semaglutide plus cilofexor 100 mg (n = 22), semaglutide plus firsocostat (n = 22) or semaglutide, cilofexor 30 mg and firsocostat (n = 21).

    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.

  4. 05HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome

    In patients with NASH, combinations of semaglutide with cilofexor and/or firsocostat gave greater improvements in liver biochemistry than semaglutide monotherapy.

    In plain wordsIn people with NASH, semaglutide with cilofexor or firsocostat improved liver blood tests more than semaglutide alone.

    Peptide
    Semaglutide
    Outcome
    Direction not reportedLiver biochemistry with combination therapy
    Study

    n: not reported in source

    Comparator
    Semaglutide monotherapy
    Analysis
    Exploratory
    Outcome group
    Liver fat and liver function · Liver

    Source sentences

    Summary
    compared with semaglutide monotherapy, combinations resulted in greater improvements in liver steatosis measured by MRI-PDFF (least-squares mean of absolute changes: -9.8 to -11.0% vs. -8.0%), liver biochemistry, and non-invasive tests of fibrosis.
    2 context sentences
    Summary · context
    This was a phase II, open-label, proof-of-concept trial in which patients with NASH (F2-F3 on biopsy, or MRI-proton density fat fraction [MRI-PDFF] ≥10% and liver stiffness by transient elastography ≥7 kPa) were randomised to 24 weeks' treatment with semaglutide 2.4 mg once weekly as monotherapy or…
    Summary · context
    A total of 108 patients were randomised to semaglutide (n = 21), semaglutide plus cilofexor 30 mg (n = 22), semaglutide plus cilofexor 100 mg (n = 22), semaglutide plus firsocostat (n = 22) or semaglutide, cilofexor 30 mg and firsocostat (n = 21).

    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.

  5. 06HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome

    In patients with NASH, combinations of semaglutide with cilofexor and/or firsocostat gave greater improvements in non-invasive tests of fibrosis than semaglutide monotherapy.

    In plain wordsIn people with NASH, semaglutide with cilofexor or firsocostat improved scar-risk tests more than semaglutide alone.

    Peptide
    Semaglutide
    Outcome
    Direction not reportedNon-invasive tests of fibrosis with combination therapy
    Study

    n: not reported in source

    Comparator
    Semaglutide monotherapy
    Analysis
    Exploratory
    Outcome group
    Liver fat and liver function · Liver

    Source sentences

    Summary
    compared with semaglutide monotherapy, combinations resulted in greater improvements in liver steatosis measured by MRI-PDFF (least-squares mean of absolute changes: -9.8 to -11.0% vs. -8.0%), liver biochemistry, and non-invasive tests of fibrosis.
    2 context sentences
    Summary · context
    This was a phase II, open-label, proof-of-concept trial in which patients with NASH (F2-F3 on biopsy, or MRI-proton density fat fraction [MRI-PDFF] ≥10% and liver stiffness by transient elastography ≥7 kPa) were randomised to 24 weeks' treatment with semaglutide 2.4 mg once weekly as monotherapy or…
    Summary · context
    A total of 108 patients were randomised to semaglutide (n = 21), semaglutide plus cilofexor 30 mg (n = 22), semaglutide plus cilofexor 100 mg (n = 22), semaglutide plus firsocostat (n = 22) or semaglutide, cilofexor 30 mg and firsocostat (n = 21).

    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 trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 ongoing · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

RecruitingNot applicableNCT06060392

Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus

Medanta, The Medicity, Indian = 5030 Oct 2023 to est. 1 Nov 2025

Liver Transplant; Complications · Diabete Mellitus

Trial pageClinicalTrials.govUpdated 13 Jun 2025
CompletedPhase 2Results postedNCT03987074

Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

Gilead Sciencesn = 10929 Jul 2019 to 13 Jul 2020

Nonalcoholic Steatohepatitis

Trial pageClinicalTrials.govUpdated 15 Jul 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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