Liver disease · Phase 2
IMPACT: biopsy-confirmed MASH
What was tested?
Pemvidutide versus placebo in adults with biopsy-confirmed steatohepatitis and stage F2 or F3 fibrosis. ↗
Registered primary question: Two histology outcomes at week 24: disease resolution without worsening fibrosis, and fibrosis improvement without worsening disease; the registry also lists adverse events through week 52. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
The study met the endpoint of MASH resolution without worsening fibrosis, but did not meet the fibrosis-improvement endpoint without worsening MASH. Adverse events were reported in 78% and 81% of active groups versus 67% with placebo.↗
Keep in context: The selected publication reports the 24-week analysis. One histology endpoint was met and the other was not; this should not be summarized as demonstrated fibrosis benefit. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 212 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 18 Years to 75 Years
- Registry results
- Not posted in this snapshot
Registry source ↗ · Updated 2026-05-18; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
IMPACT: biopsy-confirmed MASH
- Design in the report
- Randomized, double-blind, placebo-controlled phase 2 trial; NCT05989711; two coprimary histology endpoints at week 24.↗
- Participants in the report
- 212 participants with MASH and stage F2 or F3 fibrosis participated.↗
- Limitations
- The abstract does not fully describe handling of missing biopsy outcomes. Longer follow-up was ongoing; a favorable disease-activity endpoint does not establish fibrosis benefit or fewer clinical events.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) ↗
Protocol identifier: ALT- 801-203. Sponsor: Altimmune, Inc..
Retrieved 2026-09-20; SHA-256 479c36b141fd86c8fae6746a1bc773861ad9f2788575ad5828b2e74885222bb0.
PMID 41237796
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 41237796. SHA-256 adc8edd8b150d99a3641ddbc74c59db6916cf35d9d6246838aaff2cc195ae1cb.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 dc020308c93198cfa3c4163c9eb9c575c301825253480a1bfa07d377614feda9.