Recruiting
Phase 3

Pemvidutide

Sponsor:

Altimmune, Inc.

Code:

NCT07795164

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pemvidutide

Placebo

Study Details

Brief summary:

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.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Study ID

NCT07795164

Start date

Jul 30, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pemvidutide 1.8 mg

experimental: Pemvidutide 2.4 mg

placebo comparator: Placebo

Interventions

Pemvidutide

Pemvidutide SC Injection

Placebo

Placebo SC Injection

Primary outcome measure

  • Clinical Outcome Event [ Time Frame: Baseline through end of study (approximately Month 60) ]
  • Histological Response: MASH resolution [ Time Frame: Baseline through Week 52 ]
  • Histological Response: Fibrosis improvement [ Time Frame: Baseline through Week 52 ]

Central Contacts and Locations

Central contacts

Shaheen Tomah, MD

240-654-1450stomah@altimmune.com

Locations

Altimmune Clinical Study Site

Recruiting

North Little Rock, Arkansas, United States, 72117

Altimmune Clinical Study Site

Recruiting

Fountain Valley, California, United States, 92708

Altimmune Clinical Study Site

Recruiting

Fresno, California, United States, 93720

Altimmune Clinical Study Site

Recruiting

Gardena, California, United States, 90247

Altimmune Clinical Study Site

Recruiting

Long Beach, California, United States, 90815

Altimmune Clinical Study Site

Recruiting

Miami, Florida, United States, 33173

Altimmune Clinical Study Site

Recruiting

Ocala, Florida, United States, 34471

Altimmune Clinical Study Site

Recruiting

Springboro, Ohio, United States, 45066

Altimmune Clinical Study Site

Recruiting

Westlake, Ohio, United States, 44145

More Information

Sponsor

Altimmune, Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Altimmune, Inc. on 2026-08-31.