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RecruitingNCT07795164PERFORMAUpdated Sep 23, 2026

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

A Phase 3 interventional study of Pemvidutide and Placebo in Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Altimmune, Inc.. Recruiting at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Altimmune, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,800
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,800 participants (estimated)

Study arms

  • Experimental
    Pemvidutide 1.8 mg

    Drug: Pemvidutide

  • Experimental
    Pemvidutide 2.4 mg

    Drug: Pemvidutide

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugPemvidutide

    Pemvidutide SC Injection

  • OtherPlacebo

    Placebo SC Injection

05

What researchers measure

Primary outcomes

  1. 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

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

  2. Histological Response: MASH resolution

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

    Time frame: Baseline through Week 52

  3. 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

    Time frame: Baseline through Week 52

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

    Time frame: Baseline through Week 52

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

    Time frame: Baseline through Week 52

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

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

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

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

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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

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

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

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

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

    Time frame: 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.

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

06

Study locations

9 of 9 sites recruiting
  • Altimmune Clinical Study Site
    North Little Rock, Arkansas 72117, United States
    Recruiting
  • Altimmune Clinical Study Site
    Fountain Valley, California 92708, United States
    Recruiting
  • Altimmune Clinical Study Site
    Fresno, California 93720, United States
    Recruiting
  • Altimmune Clinical Study Site
    Gardena, California 90247, United States
    Recruiting
  • Altimmune Clinical Study Site
    Long Beach, California 90815, United States
    Recruiting
  • Altimmune Clinical Study Site
    Miami, Florida 33173, United States
    Recruiting
  • Altimmune Clinical Study Site
    Ocala, Florida 34471, United States
    Recruiting
  • Altimmune Clinical Study Site
    Springboro, Ohio 45066, United States
    Recruiting
  • Altimmune Clinical Study Site
    Westlake, Ohio 44145, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07795164
Lead sponsor
Altimmune, Inc.
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Jul 30, 2026
Primary completion
Dec 2028 (estimated)
Completion
Dec 2032 (estimated)
Last update
Sep 23, 2026

Study contacts

Shaheen Tomah, MD
Contact
performa@altimmune.com
240-235-0145

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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