Status:
COMPLETED
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
Lead Sponsor:
Altimmune, Inc.
Conditions:
Non-Alcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.
Detailed Description
A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.
Eligibility Criteria
Inclusion
- Written informed consent
- Male or female 18-75 years
- Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening
- A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocyte ballooning \[0-2\])
- NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation
- Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment
- BMI ≥ 27.0 kg/m2
- Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening
- Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005)
- Liver fat content by MRI-PDFF ≥ 8%
Exclusion
- Weight gain or loss \> 5% in the 3 months prior to randomization or \> 10% in the 6 months prior to screening
- History or clinical evidence of Type 1 diabetes mellitus
- Hemoglobin A1c (HbA1c) \> 9.5% or clinically significant persistent hyperglycemia
- Liver conditions:
- History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites
- Documented causes of chronic liver disease other than NASH
- ALT or AST laboratory values \> 5 × ULN
Key Trial Info
Start Date :
July 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2025
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05989711
Start Date
July 27 2023
End Date
November 25 2025
Last Update
December 26 2025
Active Locations (40)
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1
Altimmune Clinical Study Site
Chandler, Arizona, United States, 85224
2
Altimmune Clinical Study Site
Peoria, Arizona, United States, 85345
3
Altimmune Clinical Study Site
Tucson, Arizona, United States, 85701
4
Altimmune Clinial Study Site
Tucson, Arizona, United States, 85704