Survodutide — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for Survodutide as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Nausea | 52.0 | 18.0 | +34.0 | Phase 2 obesity, highest dose |
| Vomiting | 37.0 | 4.0 | +33.0 | Phase 2 obesity |
| Constipation | 29.0 | 10.0 | +19.0 | Phase 2 obesity |
| Increased heart rate | — | — | — | Dose-dependent, attributed to the glucagon arm |
| Discontinuation for adverse events | 25.0 | 5.0 | +20.0 | Phase 2 obesity, highest dose |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Not established — investigational
§4.3Warnings and precautions
- Gastrointestinal discontinuation at the highest doses studied was high
- Heart-rate increase attributable to glucagon receptor agonism
- Glucagon-driven hepatic glucose output requires monitoring in any glycaemic indication
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
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
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.