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IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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)

NCT05989711•Altimmune, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (40)

Altimmune Clinical Study Site

Chandler, Arizona, United States

Altimmune Clinical Study Site

Peoria, Arizona, United States

Altimmune Clinical Study Site

Tucson, Arizona, United States

Altimmune Clinial Study Site

Tucson, Arizona, United States

Altimmune Clinical Study Site

North Hollywood, California, United States

Altimmune Clinical Study Site

Panorama City, California, United States

Altimmune Clinical Study Site

Englewood, Colorado, United States

Altimmune Clinical Study Site

Bradenton, Florida, United States

Altimmune Clinical Study Site

Fort Myers, Florida, United States

Altimmune Clinical Study Site

Hialeah Gardens, Florida, United States

Key Dates

Start Date

July 27, 2023

Primary Completion Date

April 29, 2025

Completion Date

November 25, 2025

Last Updated

December 26, 2025

Enrollment

212

ACTUAL participants

Conditions

Non-Alcoholic Steatohepatitis (NASH)

Interventions

Pemvidutide

DRUG

Placebo

DRUG

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Non-Alcoholic Steatohepatitis (NASH)

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COMPLETEDPHASE2

A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)

NCT02653300

Non-Alcoholic Steatohepatitis (NASH)Type2 Diabetes Mellitus

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH)

A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)

Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis

Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis

Endoscopic Bariatric Therapy in NASH Cirrhosis

Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis