Pemvidutide for noncirrhotic MASH: a phase 3 study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, multinational, randomized, double-blind, placebo-controlled phase 3 trial in adults with noncirrhotic MASH (F2/F3). Participants are assigned to Cohort 1 based on histology or Cohort 2 based on noninvasive tests, and will receive pemvidutide or placebo for a specified period. The study focuses on efficacy, safety, and clinical outcomes, with inclusion requirements including BMI ≥25 and diabetes or metabolic syndrome components. Key exclusions include cirrhosis, portal hypertension, active liver disease other than MASH, and uncontrolled diabetes. Liver biopsy may be required for Cohort 1 per protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All subjects:

* 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
* Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome
* Subject agrees to have liver biopsy(ies) as required per protocol

Cohort 1 - Histologic diagnosis of F2/F3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening

Cohort 2 - Presumed F2/F3 MASH based on noninvasive testing

Exclusion Criteria:

* Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C
* Uncontrolled T2D or clinically significant persistent hyperglycemia

Where it's running

• Altimmune Clinical Study Site
  North Little Rock, Arkansas, United States Recruiting
• Altimmune Clinical Study Site
  Fountain Valley, California, United States Recruiting
• Altimmune Clinical Study Site
  Fresno, California, United States Recruiting
• Altimmune Clinical Study Site
  Gardena, California, United States Recruiting
• Altimmune Clinical Study Site
  Long Beach, California, United States Recruiting
• Altimmune Clinical Study Site
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Shaheen Tomah, MD
• Email: performa@altimmune.com
• Phone: 240-235-0145

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.