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

Short name PERFORMA

NCTNCT07795164Other idALT-801-301

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 1,800 participants (estimated)
Sponsor: Altimmune, Inc. · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 30 Jul 2026
Primary completion: Dec 2028 (estimated)
Completion: Dec 2032 (estimated)
First posted: 31 Aug 2026
Last update posted: 23 Sept 2026
Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202820302032

Ph 3
PERFORMA
NCT07795164
30 Jul 2026 to est. Dec 2032

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PemvidutideDrug
PlaceboOther

Arms3

Experimental
Pemvidutide 1.8 mg
Experimental
Pemvidutide 2.4 mg
Placebo comparator
Placebo

Primary outcomes3

Outcomes the sponsor listed as primary.

Clinical Outcome Event
Time frame · Baseline through end of study (approximately Month 60)
Registry description
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
Histological Response: MASH resolution
Time frame · Baseline through Week 52
Registry description
Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network \[CRN\] classification) without worsening of fibrosis
Histological Response: Fibrosis improvement
Time frame · Baseline through Week 52
Registry description
Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH

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
Time frame · Baseline through Week 52
HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis
Time frame · Baseline through Week 52
Anthropometric parameters: Relative (%) change from baseline in body weight (kg)
Time frame · Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2)
Time frame · Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm)
Time frame · Baseline through End of Study (approximately Month 60)
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)
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)
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)
HRQoL: Change from baseline in core symptoms of MASH on the NASH-CHECK questionnaire.
Time frame · Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in Short-form 36 (SF-36) summary scores.
Time frame · Baseline through End of Study (approximately Month 60)
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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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