Two selected reports examine liver-fat changes during an extension study and histologic outcomes in a phase 2 trial. The extension continues an earlier participant cohort; it is not a separate randomized trial.12
Bottom line from this bounded source set
The extension reported liver-fat reductions among selected continuing participants. IMPACT met its MASH-resolution endpoint at 24 weeks but did not demonstrate its fibrosis-improvement endpoint. Longer-term clinical outcomes remain unestablished.12
Reviewed study record
MASLD extension
Design
Double-blind extension of a preceding randomized trial; NCT05292911.1
Population
64 participants from the earlier 94-participant study continued; this is not a new independently randomized cohort.1
Outcomes reported
At 24 weeks, reported relative liver-fat reductions were 56.3%, 75.2% and 76.4% in active groups versus 14.0% with placebo.1
Limitations
Selective extension participation can bias interpretation. MRI liver fat is not the same as histologic fibrosis improvement or patient-important liver outcomes.1
Reviewed study record
IMPACT: biopsy-confirmed MASH
Design
Randomized, double-blind, placebo-controlled phase 2 trial; NCT05989711; two coprimary histology endpoints at week 24.2
Population
212 participants with MASH and stage F2 or F3 fibrosis participated.2
Outcomes reported
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.2
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.2
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/j.jhepr.2025.101483. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s0140-6736(25)02114-2. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗