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

NCT07795164
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,800
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Lead sponsor
Altimmune, Inc.
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Start date
2026-07-30
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Number of sites
9
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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.
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Acronym
PERFORMA
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Short title
Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
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Official title
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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2032-12-01
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First posted
2026-08-31
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Registry last updated
2026-09-23
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Primary completion date
2028-12-01
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Start date
2026-07-30
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Participants
1,800
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Participant count basis
Estimated
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Planned participants
1,800
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Protocol amendments
0
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Number of sites
9
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Altimmune, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07795164
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ClinicalTrials.gov ID
NCT07795164
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Clinical Outcome Event

    Timeframe: Baseline through end of study (approximately Month 60)

    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

  2. Histological Response: MASH resolution

    Timeframe: Baseline through Week 52

    Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network \[CRN\] classification) without worsening of fibrosis

  3. Histological Response: Fibrosis improvement

    Timeframe: Baseline through Week 52

    Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH

  1. 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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through Week 52

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

    Timeframe: Baseline through End of Study (approximately Month 60)

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

    Timeframe: Baseline through End of Study (approximately Month 60)

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

    Timeframe: Baseline through End of Study (approximately Month 60)

  6. Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in alanine aminotransferase (ALT; U/L)

    Timeframe: Baseline through End of Study (approximately Month 60)

  7. Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in enhanced liver fibrosis (ELF) score

    Timeframe: Baseline through End of Study (approximately Month 60)

  8. Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Relative (%) change from baseline in vibration controlled transient elastography (VCTE; kPa) by Fibroscan

    Timeframe: Baseline through End of Study (approximately Month 60)

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

    Timeframe: Baseline through End of Study (approximately Month 60)

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

    Timeframe: Baseline through End of Study (approximately Month 60)

  11. HRQoL: Change from baseline in Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH) domain scores.

    Timeframe: Baseline through End of Study (approximately Month 60)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Altimmune Clinical Study SiteNorth Little Rock, United StatesRecruiting
  • Altimmune Clinical Study SiteFountain Valley, United StatesRecruiting
  • Altimmune Clinical Study SiteFresno, United StatesRecruiting
  • Altimmune Clinical Study SiteGardena, United StatesRecruiting
  • Altimmune Clinical Study SiteLong Beach, United StatesRecruiting
  • Altimmune Clinical Study SiteMiami, United StatesRecruiting
  • Altimmune Clinical Study SiteOcala, United StatesRecruiting
  • Altimmune Clinical Study SiteSpringboro, United StatesRecruiting
  • Altimmune Clinical Study SiteWestlake, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)