PERFORMA

RecruitingPhase 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)

Lead sponsor

Altimmune, Inc.

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Estimated enrollment

1,800

Study population

MASH / NAFLD / liver fibrosis

Eligibility highlights

•BMI ≥25

Primary endpoints

•Clinical Outcome Event•Histological Response

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07795164

Org study IDALT-801-301

Timeline

Milestones

Study start2026-07-30actual

Study first posted2026-08-31actual

Last update posted2026-09-23actual

Primary completion2028-12estimated (month precision)

Study completion2032-12estimated (month precision)

Assets

Investigational agents

Pemvidutide

Who this study enrolls

MASH / NAFLD / liver fibrosis

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot 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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver

Weight & body composition

Other (unclassified)

Patient-reported / QoL

Weight & body composition

3 endpoints

Secondary/protocol endpoint

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

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

change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

MASH / liver

8 endpoints

Primary/protocol endpoint

Histological Response: MASH resolution

Time frame:Baseline through Week 52

descriptive

Primary/protocol endpoint

Histological Response: Fibrosis improvement

Time frame:Baseline through Week 52

descriptive

Secondary/protocol endpoint

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

threshold achievement, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

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

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

change from baseline, improvement

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Clinical Outcome Event

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

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline through Week 52

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.