IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
212actual
Sites
40
Countries
Australia, Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-27 | actual | When the study began enrolling |
| Primary completion | 2025-11-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-25 | actual | The whole study's end, after follow-up |
| First posted | 2023-08-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-Alcoholic Steatohepatitis (NASH)
Interventions
- Drug: Pemvidutide
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFProportion 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
measured 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)
measured 24 weeks
Incidence of Treatment Emergent Adverse Events
measured 52 weeks
Publications
- PMID 41237796 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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