Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07795164

Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altimmune Clinical Study Site, North Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemvidutide

Drug

Pemvidutide SC Injection

Placebo

Other

Placebo SC Injection

Primary outcomes

  1. Clinical Outcome Event

    Time frame: Baseline through end of study (approximately Month 60)

    Time to first occurrence of any of the following events through the end of the study: Histologic progression to cirrhosis (F4) on liver biopsy; Liver related events; Liver transplantation; or Death due to any cause

  2. Histological Response: MASH resolution

    Time frame: Baseline through Week 52

    Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network [CRN] classification) without worsening of fibrosis

  3. Histological Response: Fibrosis improvement

    Time frame: Baseline through Week 52

    Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH

Secondary outcomes

  1. Histologic Response: Proportion of subjects achieving both MASH resolution (according to NASH CRN classification) without worsening of fibrosis and ≥ 1 stage improvement in liver fibrosis without worsening of MASH

    Time frame: Baseline through Week 52

  2. HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis

    Time frame: Baseline through Week 52

  3. Anthropometric parameters: Relative (%) change from baseline in body weight (kg)

    Time frame: Baseline through End of Study (approximately Month 60)

  4. Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2)

    Time frame: Baseline through End of Study (approximately Month 60)

  5. Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm)

    Time frame: Baseline through End of Study (approximately Month 60)

  6. Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in alanine aminotransferase (ALT; U/L)

    Time frame: Baseline through End of Study (approximately Month 60)

  7. Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in enhanced liver fibrosis (ELF) score

    Time frame: Baseline through End of Study (approximately Month 60)

  8. Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Relative (%) change from baseline in vibration controlled transient elastography (VCTE; kPa) by Fibroscan

    Time frame: Baseline through End of Study (approximately Month 60)

  9. HRQoL: Change from baseline in core symptoms of MASH on the NASH-CHECK questionnaire.

    Time frame: Baseline through End of Study (approximately Month 60)

  10. HRQoL: Change from baseline in Short-form 36 (SF-36) summary scores.

    Time frame: Baseline through End of Study (approximately Month 60)

  11. HRQoL: Change from baseline in Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH) domain scores.

    Time frame: Baseline through End of Study (approximately Month 60)

Study contacts

Contact information is provided by the study sponsor or research team.

Shaheen Tomah, MD

CONTACT

[email protected]

240-654-1450 ext. 440

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study title

A Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects With Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Acronym: PERFORMA

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.