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

May 14, 2026 updated by: Altimmune, Inc.

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Administered once weekly by subcutaneous injection
Experimental: Pemvidutide 1.2 mg
Drug: Pemvidutide
Administered once weekly by subcutaneous injection
Experimental: Pemvidutide 1.8 mg
Drug: Pemvidutide
Administered once weekly by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks
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
24 weeks
Incidence of Treatment Emergent Adverse Events
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks
Relative change (%) in liver fat content by MRI-PDFF
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Absolute change in MRI-based corrected T1 (cT1) imaging
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Absolute change in alanine aminotransferase (ALT)
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Absolute change in Enhanced Liver Fibrosis (ELF) score
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Absolute change in Fibroscan-AST (FAST) score
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Relative (%) change in body weight
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Change in HbA1c (%)
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Change in glucose (mg/dL)
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Change in systolic and diastolic blood pressure (mmHg)
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
Change in heart rate (beats per minute)
Time Frame: 24 weeks and 48 weeks
24 weeks and 48 weeks
The number of subjects with treatment emergent adverse events
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altimmune, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Actual)

November 25, 2025

Study Completion (Actual)

November 25, 2025

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALT- 801-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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