> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-3-study-of-the-efficacy-safety-and-clinical-outcomes-f2c4ee05-884b-40e3-8acc-531450ede191 > Record changed: 2026-11-04 # Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH NCT07795164 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) Participants 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) Lead sponsor Altimmune, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) Start date 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Acronym** PERFORMA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Short title** Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Dates **Completion date** 2032-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **First posted** 2026-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Registry last updated** 2026-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Start date** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Size and sites **Participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Planned participants** 1,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Lead sponsor** Altimmune, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Identifiers **Registry ID** NCT07795164 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **ClinicalTrials.gov ID** NCT07795164 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795164) ## Related records ### Drugs (1) - [Pemvidutide](https://trialight.com/data/asset/pemvidutide-84c00953-821c-44fd-ba06-b55270f15881.md) ### Lead sponsors (1) - [Altimmune, Inc.](https://trialight.com/data/company/altimmune-inc-0fdc674f-7f1f-4d65-bb16-17839afb3154.md) ### Conditions (1) - [Cirrhosis of liver](https://trialight.com/data/condition/cirrhosis-of-liver-d90e4a84-9e82-54fc-a553-1e42086e8382.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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