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Pemvidutide

Phase 2

Non-Alcoholic Steatohepatitis (NASH) | Small molecule | Infectious Disease |Altimmune, Inc.|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment212
FDA Designations
BREAKTHROUGH_THERAPYFAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05989711IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)PHASE2 COMPLETED 212 — — Jul 27, 2023Nov 25, 2025May 18, 202640 United States, Australia +1
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Study Endpoints
Primary Endpoints
Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis
24 weeks
Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)
24 weeks
Incidence of Treatment Emergent Adverse Events
52 weeks
Secondary Endpoints
Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks
24 weeks
Relative change (%) in liver fat content by MRI-PDFF
24 weeks and 48 weeks
Absolute change in MRI-based corrected T1 (cT1) imaging
24 weeks and 48 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pemvidutide 1.2 mgEXPERIMENTAL -
Pemvidutide 1.8 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PemvidutideDRUGAdministered once weekly by subcutaneous injection
PlaceboDRUGAdministered once weekly by subcutaneous injection
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: 1. Written informed consent 2. Male or female 18-75 years 3. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening 1. A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1...

Countries:United StatesAustraliaPuerto Rico
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