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CompletedNCT05989711IMPACTUpdated May 18, 2026

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

A Phase 2 interventional study of Pemvidutide and Placebo in Non-Alcoholic Steatohepatitis (NASH), sponsored by Altimmune, Inc.. Completed at 40 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Altimmune, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.

02

Conditions studied

  • Non-Alcoholic Steatohepatitis (NASH)
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Pemvidutide 1.2 mg

    Drug: Pemvidutide

  • Experimental
    Pemvidutide 1.8 mg

    Drug: Pemvidutide

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugPemvidutide

    Administered once weekly by subcutaneous injection

  • DrugPlacebo

    Administered once weekly by subcutaneous injection

05

What researchers measure

Primary outcomes

  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

  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

06

Study locations

40 sites
  • Altimmune Clinical Study Site
    Chandler, Arizona 85224, United States
  • Altimmune Clinical Study Site
    Peoria, Arizona 85345, United States
  • Altimmune Clinical Study Site
    Tucson, Arizona 85701, United States
  • Altimmune Clinial Study Site
    Tucson, Arizona 85704, United States
  • Altimmune Clinical Study Site
    North Hollywood, California 33019, United States
  • Altimmune Clinical Study Site
    Panorama City, California 91402, United States
  • Altimmune Clinical Study Site
    Englewood, Colorado 80110, United States
  • Altimmune Clinical Study Site
    Bradenton, Florida 34201, United States
  • Altimmune Clinical Study Site
    Fort Myers, Florida 33912, United States
  • Altimmune Clinical Study Site
    Hialeah Gardens, Florida 33018, United States
  • Altimmune Clinical Study Site
    Miami Lakes, Florida 33014, United States
  • Altimmune Clinical Study Site
    Port Orange, Florida 32123, United States
  • Altimmune Clinical Study Site
    Sarasota, Florida 34240, United States
  • Altimmune Clinical Study Site
    West Palm Beach, Florida 33401, United States
  • Altimmune Clinical Study Site
    Dalton, Georgia 30720, United States
  • Altimmune Clinical Study Site
    Marietta, Georgia 30006, United States
  • Altimmune Clinical Study Site
    Bastrop, Louisiana 78602, United States
  • Altimmune Clinical Study Site
    Shreveport, Louisiana 71101, United States
  • Altimmune Clinical Study Site
    Clarksville, Tennessee 37040, United States
  • Altimmune Clinical Study Site
    Germantown, Tennessee 38138, United States
  • Altimmune Clinical Study Site
    Austin, Texas 73301, United States
  • Altimmune Clinical Study Site
    Bellaire, Texas 77401, United States
  • Altimmune Clinical Study Site
    Edinburg, Texas 78539, United States
  • Altimmune Clinical Study Site
    Edinburg, Texas 78540, United States
  • Altimmune Clinical Study Site
    Georgetown, Texas 78626, United States
  • Altimmune Clinical Study Site
    Houston, Texas 77036, United States
  • Altimmune Clinical Study Site
    San Antonio, Texas 78201, United States
  • Altimmune Clinical Study Site
    San Antonio, Texas 78204, United States
  • Altimmune Clinical Study Site
    West Jordan, Utah 84081, United States
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales 2050, Australia
  • Liverpool Hospital
    Liverpool, New South Wales 2170, Australia
  • Princess Alexandra Hospital/ Translational Research Institute
    Woolloongabba, Queensland 4102, Australia
  • Flinders Medical Centre
    Bedford Park, South Australia 5042, Australia
  • St. Vincent's Hospital Melbourne
    Fitzroy, Victoria 3065, Australia
  • Austin Health
    Heidelberg, Victoria 3084, Australia
  • Box Hill Hospital
    Box Hill, Victory 3128, Australia
  • Monash Hospital
    Clayton, Victory 3168, Australia
  • Fiona Stanley Hospital
    Murdoch, Western Australia 6150, Australia
  • Sir Charles Gairdner Hospital
    Nedlands, Western Australia 6009, Australia
  • Altimmune Clinical Study Site
    San Juan, 00901, Puerto Rico
07

References and documents

Publications

  • Noureddin M, Harrison SA, Loomba R, Alkhouri N, Chalasani N, Sheikh MY, Tomah S, Gutierrez JA, Urbina S, Suschak JJ, Brown R, Odili O, Yang J, Keeton S, Neff G, Mena E, Roberts MS, Browne SK, Harris MS. 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. Lancet. 2025 Dec 6;406(10520):2644-2655. doi: 10.1016/S0140-6736(25)02114-2. Epub 2025 Nov 11. PubMed 41237796 ↗
08

Registry details

Key details

Study ID
NCT05989711
Lead sponsor
Altimmune, Inc.
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Jul 27, 2023
Primary completion
Nov 25, 2025
Completion
Nov 25, 2025
Last update
May 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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