Survodutide in metabolic dysfunction-associated steatohepatitis — evidence extract
The Institute's graded assessment of Survodutide for metabolic dysfunction-associated steatohepatitis, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Metabolic dysfunction-associated steatohepatitis
§1.1Question and anchor outcome
- Population
- Steatotic liver disease with histological evidence of hepatocyte ballooning and lobular inflammation occurring in the context of at least one cardiometabolic risk factor. Formerly termed non-alcoholic steatohepatitis.
- Intervention
- Survodutide, subcutaneous once weekly
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Resolution of steatohepatitis without worsening of fibrosis
Additional outcomes the Institute extracts for this indication: Improvement of fibrosis by ≥1 stage without worsening of steatohepatitis; Change in liver stiffness by vibration-controlled transient elastography; Change in ALT.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Survodutide in metabolic dysfunction-associated steatohepatitis.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| LIVERAGE | 2 | Randomised, double-blind, placebo-controlled | 52 | 48 weeks | 2016 |
| SURVO-PH2-MASH | 2 | Randomised, double-blind, placebo-controlled | 295 | 48 weeks | 2024 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | Very serious | The outcome is a surrogate whose relationship to the clinical outcome is unvalidated for this indication. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from the estimate. | ||
§1.4What this extract does not establish
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.
- le Roux CW, Steen O, Lucas KJ, Startseva E, Unseld A, Hennige AM. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. The Lancet Diabetes & Endocrinology 2024;12(3):162–173. doi:10.1016/S2213-8587(23)00356-X · PMID 38330977
- Sanyal AJ, Bedossa P, Fraessdorf M, Neff GW, Lawitz E, Bugianesi E, Anstee QM, Hussain SA, Newsome PN, Ratziu V, Hosseini-Tabatabaei A, Schattenberg JM. A phase 2 randomized trial of survodutide in MASH and fibrosis. New England Journal of Medicine 2024;391(4):311–319. doi:10.1056/NEJMoa2401755 · PMID 38847460
- Müller TD, Finan B, Bloom SR, D’Alessio D, Drucker DJ, Flatt PR, Fritsche A, Gribble F, Grill HJ, Habener JF, Holst JJ, Langhans W, Meier JJ, Nauck MA, Perez-Tilve D, Pocai A, Reimann F, Sandoval DA, Schwartz TW, Seeley RJ. Glucagon-like peptide 1 (GLP-1). Molecular Metabolism 2019;30:72–130. doi:10.1016/j.molmet.2019.09.010 · PMID 31767182
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.