Metabolic dysfunction-associated steatohepatitis — compounds assessed
The 5 compounds the Institute assesses in metabolic dysfunction-associated steatohepatitis.
§4Compounds assessed
Compounds the Institute assesses in this indication, with the class of each and its overall certainty. A compound appears here whether or not the evidence supports its use, because recording that a compound has been studied and found wanting is as much part of the assessment as recording that one has not.
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Resolution of steatohepatitis without worsening of fibrosis in 62.9 % versus 34.3 % with placebo at 72 weeks — Part 1 of a two-part trial; the clinical-outcome part had not reported at this assessment cycle.
Moderate -
Liver-fat reduction exceeding 80 % relative at higher doses in a phase 2 imaging substudy — Imaging surrogate only; no histological endpoint reported.
Low -
Histological improvement in fibrosis without worsening of steatohepatitis in 34.5 % at 4.8 mg versus 22.4 % with placebo at 48 weeks — Phase 2 with a paired-biopsy endpoint in a modest sample; the fibrosis result is hypothesis-generating.
Low -
Liver fat fraction reduced by 4.1 percentage points versus 0.9 with placebo at 12 months in people with HIV and hepatic steatosis — Small single trial in a specific population.
Low -
Resolution of steatohepatitis without worsening fibrosis in 44–62 % across doses versus 10 % with placebo at 52 weeks — Phase 2 only, wide confidence limits, no phase 3 histological result at this cycle.
Low
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF. Once-weekly semaglutide in adults with overweight or obesity. New England Journal of Medicine 2021;384(11):989–1002. doi:10.1056/NEJMoa2032183 · PMID 33567185
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.