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Trial · Interventional

CompletedPhase 2Registry data

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

Short name IMPACT

NCTNCT05989711 (opens ClinicalTrials.gov in a new tab)Other idALT- 801-203
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
212 participants (actual)
Sponsor
Altimmune, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
3 countries

United States, Australia, Puerto Rico

Start
27 Jul 2023
Primary completion
25 Nov 2025
Completion
25 Nov 2025
First posted
14 Aug 2023
Last update posted
18 May 2026
Conditions
Non-Alcoholic Steatohepatitis (NASH)

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 2

    IMPACT

    NCT05989711

    27 Jul 2023 to 25 Nov 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.

Interventions

  • PemvidutideDrug
  • PlaceboDrug

Arms3

  • Experimental

    Pemvidutide 1.2 mg

  • Experimental

    Pemvidutide 1.8 mg

  • Placebo comparator

    Placebo

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis

    Time frame · 24 weeks

  2. Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)

    Time frame · 24 weeks

  3. Incidence of Treatment Emergent Adverse Events

    Time frame · 52 weeks

Secondary outcomes(13)

  1. Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks

    Time frame · 24 weeks

  2. Relative change (%) in liver fat content by MRI-PDFF

    Time frame · 24 weeks and 48 weeks

  3. Absolute change in MRI-based corrected T1 (cT1) imaging

    Time frame · 24 weeks and 48 weeks

  4. Absolute change in alanine aminotransferase (ALT)

    Time frame · 24 weeks and 48 weeks

  5. Absolute change in Enhanced Liver Fibrosis (ELF) score

    Time frame · 24 weeks and 48 weeks

  6. Absolute change in Fibroscan-AST (FAST) score

    Time frame · 24 weeks and 48 weeks

  7. Relative (%) change in body weight

    Time frame · 24 weeks and 48 weeks

  8. Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)

    Time frame · 24 weeks and 48 weeks

  9. Change in HbA1c (%)

    Time frame · 24 weeks and 48 weeks

  10. Change in glucose (mg/dL)

    Time frame · 24 weeks and 48 weeks

  11. Change in systolic and diastolic blood pressure (mmHg)

    Time frame · 24 weeks and 48 weeks

  12. Change in heart rate (beats per minute)

    Time frame · 24 weeks and 48 weeks

  13. The number of subjects with treatment emergent adverse events

    Time frame · 48 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 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 et al. 2025Lancet (London, England)cited by 29

PMID 41237796DOI 10.1016/s0140-6736(25)02114-2PUB-41237796

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Written informed consent 2. Male or female 18-75 years 3. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening 1. A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocyte ballooning \[0-2\]) 2. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation 4. Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment 5. BMI ≥ 27.0 kg/m2 6. Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening 7. Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005) 8. Liver fat content by MRI-PDFF ≥ 8% Exclusion Criteria: 1. Weight gain or loss \> 5% in the 3 months prior to randomization or \> 10% in the 6 months prior to screening 2. History or clinical evidence of Type 1 diabetes mellitus 3. Hemoglobin A1c (HbA1c) \> 9.5% or clinically significant persistent hyperglycemia 4. Liver conditions: 1. History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites 2. Documented causes of chronic liver disease other than NASH 3. ALT or AST laboratory values \> 5 × ULN

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