Pemvidutide for Nonalcoholic Steatohepatitis (NASH)
(IMPACT Trial)

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Altimmune, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing pemvidutide, a medication that may help treat NASH, a liver disease. It aims to see if the drug can reduce liver damage and help the liver heal.

Research Team

Eligibility Criteria

Adults aged 18-75 with moderate to severe NASH (stages 2-3 fibrosis) can join this trial. They must have a confirmed diagnosis, certain levels of liver fat and inflammation, and meet criteria for Metabolic Syndrome. Those with Type 1 diabetes, recent significant weight changes, or very high liver enzymes cannot participate.

Inclusion Criteria

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])

I agree to undergo a liver biopsy if needed.

Written informed consent

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Exclusion Criteria

Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening

ALT or AST laboratory values > 5 × ULN

My blood sugar levels are very high or my HbA1c is above 9.5%.

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Treatment Details

Interventions

Pemvidutide (Glucagon-like peptide-1 (GLP-1) receptor agonist)

Trial OverviewThe IMPACT Trial is testing Pemvidutide's effectiveness on resolving NASH without worsening fibrosis compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and will undergo liver biopsies before and after treatment.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Pemvidutide 1.8 mg (n=76)Experimental Treatment1 Intervention

Group II: Pemvidutide 1.2 mg (n=38)Experimental Treatment1 Intervention

Group III: Placebo (n=76)Placebo Group1 Intervention