Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
PERFORMA
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)
1 other identifier
interventional
1,800
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2026
Longer than P75 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2026
CompletedFirst Submitted
Initial submission to the registry
August 14, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
September 23, 2026
September 1, 2026
2.3 years
August 14, 2026
September 21, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Clinical Outcome Event
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
Baseline through end of study (approximately Month 60)
Histological Response: MASH resolution
Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network \[CRN\] classification) without worsening of fibrosis
Baseline through Week 52
Histological Response: Fibrosis improvement
Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH
Baseline through Week 52
Secondary Outcomes (11)
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
Baseline through Week 52
HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis
Baseline through Week 52
Anthropometric parameters: Relative (%) change from baseline in body weight (kg)
Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2)
Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm)
Baseline through End of Study (approximately Month 60)
- +6 more secondary outcomes
Study Arms (3)
Pemvidutide 1.8 mg
EXPERIMENTALPemvidutide 2.4 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Altimmune, Inc.lead
Study Sites (9)
Altimmune Clinical Study Site
North Little Rock, Arkansas, 72117, United States
Altimmune Clinical Study Site
Fountain Valley, California, 92708, United States
Altimmune Clinical Study Site
Fresno, California, 93720, United States
Altimmune Clinical Study Site
Gardena, California, 90247, United States
Altimmune Clinical Study Site
Long Beach, California, 90815, United States
Altimmune Clinical Study Site
Miami, Florida, 33173, United States
Altimmune Clinical Study Site
Ocala, Florida, 34471, United States
Altimmune Clinical Study Site
Springboro, Ohio, 45066, United States
Altimmune Clinical Study Site
Westlake, Ohio, 44145, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2026
First Posted
August 31, 2026
Study Start
July 30, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2032
Last Updated
September 23, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share