IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
Part of paid clinical trials in Chandler, Arizona.
- Sponsor
- Altimmune, Inc.
- Study ID
- NCT05989711
- Phase
- PHASE2
- Status
- Completed
Conditions
- Non-Alcoholic Steatohepatitis (NASH)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pemvidutide — DRUGAdministered once weekly by subcutaneous injection
- Placebo — DRUGAdministered once weekly by subcutaneous injection
Study Details
Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.
Key Dates
- Start date
- Jul 27, 2023
- Status verified
- May 2026
- Primary completion
- Nov 25, 2025
- Completion
- Nov 25, 2025
Study Design
- Enrollment
- 212 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Pemvidutide 1.2 mg
- Experimental: Pemvidutide 1.8 mg
- Placebo Comparator: Placebo
Primary Outcome Measure
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 [ Time Frame: 24 weeks ]