Liver disease · Phase 2
Survodutide: MASH and fibrosis
What was tested?
Survodutide versus placebo in adults with biopsy-confirmed steatohepatitis and fibrosis. ↗
Registered primary question: Improvement in liver histology after 48 weeks, with analyses by planned and actual maintenance treatment. ↗
What the reviewed report found
Journal year 2024 · Article summary reviewed 2026-09-15
Improvement in steatohepatitis without worsening fibrosis was reported in 43% to 62% across survodutide groups and 14% with placebo. Improvement in fibrosis by at least one stage was reported in 34% to 36% and 22%, respectively.↗
Keep in context: The reported primary result was improvement in steatohepatitis without worsening fibrosis. Improvement in fibrosis itself was a separate secondary outcome. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 295 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 18 Years to 80 Years
- Registry results
- Posted in this snapshot
Registry source ↗ · Updated 2024-12-03; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Phase 2 MASH and fibrosis trial
- Design in the report
- A randomized, placebo-controlled Phase 2 trial assessed histologic improvement in steatohepatitis without worsening fibrosis over 48 weeks.↗
- Participants in the report
- The trial treated 293 adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis and fibrosis stages F1 through F3.↗
- Limitations
- The sponsor-funded, 48-week Phase 2 trial was not designed to establish long-term liver-related clinical outcomes or uncommon harms, and the fibrosis result was a secondary endpoint.↗
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
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3) ↗
Protocol identifier: 1404-0043. Sponsor: Boehringer Ingelheim.
Retrieved 2026-09-20; SHA-256 9d26b4d6d050d31d899b83827781956db5d569fbdaf1f6dda9d6207d4bb5d8d9.
PMID 38847460
A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis ↗
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 38847460. SHA-256 f2177628b98083064df17512c3dd229b760887c00cc64c4cfa4fc4e49523b12a.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 7f3ce949e27c7ac79fc7f5dd37e709d2fea19edd0b0b04b599c4d49e4b6b1093.