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Study · Randomized controlled trial · 2025

11 results

Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study.

Harrison SA, Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Roberts MS, Harris MS

Journal of hepatology11 Jul 2024Cited by 134 (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-ND. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In MASLD, pemvidutide 1.2 mg reduced liver fat by 46.6% versus 4.4% with placebo.

    In plain wordsIn MASLD, pemvidutide reduced liver fat more than placebo.

    Outcome
    DecreaseRelative liver fat reduction
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.2 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Relative reduction in liver fat content from baseline
    46.6%
    pemvidutide 1.2 mg, week 12
    Relative reduction in liver fat content from baseline
    4.4%
    placebo, week 12

    Source sentences

    Summary
    At week 12, relative reductions in LFC from baseline were 46.6% (95% CI -63.7 to -29.6), 68.5% (95% CI -84.4 to -52.5), and 57.1% (95% CI -76.1 to -38.1) for the pemvidutide 1.2 mg, 1.8 mg, and 2.4 mg groups, respectively, vs. 4.4% (95% CI -20.2 to 11.3) for the placebo group (p <0.001 vs. placebo,…
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In MASLD, pemvidutide 1.8 mg reduced liver fat by 68.5% versus 4.4% with placebo.

    In plain wordsIn MASLD, pemvidutide reduced liver fat more than placebo.

    Outcome
    DecreaseRelative liver fat reduction
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Relative reduction in liver fat content from baseline
    68.5%
    pemvidutide 1.8 mg, week 12
    Relative reduction in liver fat content from baseline
    4.4%
    placebo, week 12

    Source sentences

    Summary
    At week 12, relative reductions in LFC from baseline were 46.6% (95% CI -63.7 to -29.6), 68.5% (95% CI -84.4 to -52.5), and 57.1% (95% CI -76.1 to -38.1) for the pemvidutide 1.2 mg, 1.8 mg, and 2.4 mg groups, respectively, vs. 4.4% (95% CI -20.2 to 11.3) for the placebo group (p <0.001 vs. placebo,…
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In MASLD, pemvidutide 2.4 mg reduced liver fat by 57.1% versus 4.4% with placebo.

    In plain wordsIn MASLD, pemvidutide reduced liver fat more than placebo.

    Outcome
    DecreaseRelative liver fat reduction
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    2.4 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Relative reduction in liver fat content from baseline
    57.1%
    pemvidutide 2.4 mg, week 12
    Relative reduction in liver fat content from baseline
    4.4%
    placebo, week 12

    Source sentences

    Summary
    At week 12, relative reductions in LFC from baseline were 46.6% (95% CI -63.7 to -29.6), 68.5% (95% CI -84.4 to -52.5), and 57.1% (95% CI -76.1 to -38.1) for the pemvidutide 1.2 mg, 1.8 mg, and 2.4 mg groups, respectively, vs. 4.4% (95% CI -20.2 to 11.3) for the placebo group (p <0.001 vs. placebo,…
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In MASLD, 94.4% achieved a 30% liver fat reduction with pemvidutide 1.8 mg.

    In plain wordsIn MASLD, most patients at this pemvidutide dose achieved the reported liver fat reduction.

    Outcome
    Not applicableLiver fat reduction of 30%
    Study

    n: not reported in source

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Patients achieving 30% liver fat reduction
    94.4%
    pemvidutide 1.8 mg, week 12

    Source sentences

    Summary
    with 94.4% and 72.2% of patients achieving 30% and 50% reductions in LFC and 55.6% achieving normalization (≤5% LFC) at the 1.8 mg dose.
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In MASLD, 72.2% achieved a 50% liver fat reduction with pemvidutide 1.8 mg.

    In plain wordsIn MASLD, most patients at this pemvidutide dose achieved the reported liver fat reduction.

    Outcome
    Not applicableLiver fat reduction of 50%
    Study

    n: not reported in source

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Patients achieving 50% liver fat reduction
    72.2%
    pemvidutide 1.8 mg, week 12

    Source sentences

    Summary
    with 94.4% and 72.2% of patients achieving 30% and 50% reductions in LFC and 55.6% achieving normalization (≤5% LFC) at the 1.8 mg dose.
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In MASLD, 55.6% achieved liver fat normalization (≤5% LFC) with pemvidutide 1.8 mg.

    In plain wordsIn MASLD, over half of patients at this pemvidutide dose achieved liver fat normalization.

    Outcome
    Not applicableLiver fat normalization
    Study

    n: not reported in source

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Patients achieving liver fat normalization (<=5% LFC)
    55.6%
    pemvidutide 1.8 mg, week 12

    Source sentences

    Summary
    with 94.4% and 72.2% of patients achieving 30% and 50% reductions in LFC and 55.6% achieving normalization (≤5% LFC) at the 1.8 mg dose.
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In MASLD, pemvidutide 1.8 mg reduced body weight by 4.3%, with a significant difference versus placebo.

    In plain wordsIn MASLD, pemvidutide reduced body weight compared with placebo.

    Outcome
    DecreaseBody weight
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    1.8 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Maximal weight loss
    −4.3%
    pemvidutide 1.8 mg, week 12

    Source sentences

    Summary
    Maximal responses for weight loss (-4.3%; p <0.001), alanine aminotransferase (-13.8 IU/L; p = 0.029), and corrected cT1 (-75.9 ms; p = 0.002) were all observed at the 1.8 mg dose.
    2 context sentences
    Summary · context
    In patients with MASLD, weekly pemvidutide treatment yielded significant reductions in LFC, markers of hepatic inflammation, and body weight compared to placebo.
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In MASLD, the maximal alanine aminotransferase response was -13.8 IU/L with pemvidutide 1.8 mg.

    In plain wordsIn MASLD, pemvidutide 1.8 mg lowered the reported liver enzyme level.

    Outcome
    DecreaseAlanine aminotransferase
    Study

    n: not reported in source

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Maximal alanine aminotransferase change
    −13.8 IU/L
    pemvidutide 1.8 mg, week 12

    Source sentences

    Summary
    Maximal responses for weight loss (-4.3%; p <0.001), alanine aminotransferase (-13.8 IU/L; p = 0.029), and corrected cT1 (-75.9 ms; p = 0.002) were all observed at the 1.8 mg dose.
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In MASLD, the maximal corrected cT1 response was -75.9 ms with pemvidutide 1.8 mg.

    In plain wordsIn MASLD, pemvidutide 1.8 mg lowered the reported corrected cT1 liver measure.

    Outcome
    DecreaseCorrected cT1
    Study

    n: not reported in source

    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.8 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Measurements

    Maximal corrected cT1 change
    −75.9 ms
    pemvidutide 1.8 mg, week 12

    Source sentences

    Summary
    Maximal responses for weight loss (-4.3%; p <0.001), alanine aminotransferase (-13.8 IU/L; p = 0.029), and corrected cT1 (-75.9 ms; p = 0.002) were all observed at the 1.8 mg dose.
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  10. 10HumanRandomized controlled trialSafety outcome

    In MASLD, no severe adverse events were reported with pemvidutide at any dose.

    In plain wordsIn MASLD, no severe adverse events were reported with pemvidutide.

    Outcome
    Not applicableSevere adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    1.2 mg, 1.8 mg or 2.4 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Pemvidutide was well-tolerated at all doses with no severe or serious adverse events.
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.
  11. 11HumanRandomized controlled trialSafety outcome

    In MASLD, no serious adverse events were reported with pemvidutide at any dose.

    In plain wordsIn MASLD, no serious adverse events were reported with pemvidutide.

    Outcome
    Not applicableSerious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    1.2 mg, 1.8 mg or 2.4 mg · subcutaneous once weekly · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Pemvidutide was well-tolerated at all doses with no severe or serious adverse events.
    1 context sentence
    Summary · context
    Patients with a BMI ≥28.0 kg/m2 and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks.

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 1NCT05006885

ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

Altimmune, Inc.n = 9530 Sept 2021 to 17 Aug 2022

Non-Alcoholic Fatty Liver Disease

Trial pageClinicalTrials.govUpdated 27 Jul 2023

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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