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1800 Participants NeededMy employer runs this trial

Pemvidutide for Non-Alcoholic Fatty Liver Disease

(PERFORMA Trial)

Recruiting at 8 trial locations
ST
Overseen ByShaheen Tomah, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Altimmune, Inc.
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Phase 3, multicenter, multinational, 2-cohort, randomized, double-blind, placebo controlled, parallel-group pivotal study to evaluate the efficacy, safety, and clinical outcomes of pemvidutide treatment in subjects with noncirrhotic (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH). Participants will be assigned either to Cohort 1 based on screening histologic (liver biopsy) criteria or to Cohort 2 based on non-invasive test criteria.

Are You a Good Fit for This Trial?

This trial is for adults with metabolic dysfunction-associated steatohepatitis (MASH) who do not have cirrhosis but show moderate to advanced liver scarring (F2 or F3). Participants are selected based on either a liver biopsy or non-invasive tests.

Inclusion Criteria

No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening or since the historical biopsy if applicable
Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2
I have type 2 diabetes or at least two signs of metabolic syndrome.
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Exclusion Criteria

Liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges
I have severe liver disease or cirrhosis not caused by MASH.
Positive HBsAg
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What Are the Treatments Tested in This Trial?

Interventions

  • Pemvidutide

Trial Overview

The study compares the effects of pemvidutide, an investigational medication, against a placebo in people with MASH. Participants are randomly assigned to receive either pemvidutide or placebo without knowing which one they get.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Pemvidutide 2.4 mgExperimental Treatment1 Intervention
Group II: Pemvidutide 1.8 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Altimmune, Inc.

Lead Sponsor

Trials
17
Recruited
1,500+

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