NCT07795164RecruitingPhase 3
Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
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)
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1800 (estimated)
- First submitted
- 14 Aug 2026
- Start date
- 30 Jul 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Altimmune, Inc.
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07795164
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1800
- From 30 Jul 2026 to the primary completion date, 31 Dec 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Other
- Uncontrolled T2D or clinically significant persistent hyperglycemia
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | Fresno | United States | Recruiting |
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | Gardena | United States | Recruiting |
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | North Little Rock | United States | Recruiting |
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | Springboro | United States | Recruiting |
| Altimmune Clinical Study Site Coordinator of this site? Confirm its status | Westlake | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.