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

Part of paid clinical trials in North Little Rock, Arkansas.

Sponsor
Altimmune, Inc.
Study ID
NCT07795164
Phase
PHASE3
Status
Recruiting
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Conditions

  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pemvidutide — DRUG
    Pemvidutide SC Injection
  • Placebo — OTHER
    Placebo SC Injection

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Jul 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
1,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pemvidutide 1.8 mg
  • Experimental: Pemvidutide 2.4 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Clinical Outcome Event [ Time Frame: Baseline through end of study (approximately Month 60) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Altimmune Clinical Study SiteNorth Little RockArkansas72117-
Altimmune Clinical Study SiteFountain ValleyCalifornia92708-
Altimmune Clinical Study SiteFresnoCalifornia93720-
Altimmune Clinical Study SiteGardenaCalifornia90247-
Altimmune Clinical Study SiteLong BeachCalifornia90815-
Altimmune Clinical Study SiteMiamiFlorida33173-
Altimmune Clinical Study SiteOcalaFlorida34471-
Altimmune Clinical Study SiteSpringboroOhio45066-
Altimmune Clinical Study SiteWestlakeOhio44145-

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