Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
← catalyst calendarNCT07795164 · readout ≤ 852 d
Sponsored by Altimmune, Inc. (industry) · ALT — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,800estimated
Sites
9
Country
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 2026-08-31
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-30 | actual | When the study began enrolling |
| Primary completion | Dec 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Interventions
- Drug: Pemvidutide
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFClinical Outcome Event
measured Baseline through end of study (approximately Month 60)
Histological Response: MASH resolution
measured Baseline through Week 52
Histological Response: Fibrosis improvement
measured Baseline through Week 52
Related
ALT · their whole pipeline · MASH / Nonalcoholic Steatohepatitis readouts
ALT's other studiesmost recently updated first
- RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) Phase 2 · Active, not recruiting
- RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight Phase 2 · Completed
- IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) Phase 2 · Completed
- HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB) Phase 2 · Terminated
- NasoShield Study of Safety and Immunogenicity Phase 1 · Completed
Permalink · ALT's whole pipeline · Catalyst calendar · Every registered study · What changed