Survodutide — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Obesity and overweight in adults
Anchor outcome. Percentage change in body weight from baseline.
Effect as recorded. −14.9 % body weight at 46 weeks with 6.0 mg in phase 2 versus −2.8 % with placebo; estimated difference −12.1 percentage points (95 % CI −15.4 to −8.8).[1,2]
Certainty. Moderate certainty Phase 2 dose-finding, 387 participants; phase 3 unreported at this cycle.
Contributing trials. SYNCHRONIZE-1 · SYNCHRONIZE-2 · SURVO-PH2-OBESITY. Full structured abstracts are published for each.
Full evidence extract for obesity and overweight in adults · Indication assessment
§3.2Metabolic dysfunction-associated steatohepatitis
Anchor outcome. Resolution of steatohepatitis without worsening of fibrosis.
Effect as recorded. 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; wide confidence limits.[2,3]
Certainty. Low certainty Phase 2 with a paired-biopsy endpoint in a modest sample; the fibrosis result is hypothesis-generating.
Contributing trials. LIVERAGE · SURVO-PH2-MASH. Full structured abstracts are published for each.
Full evidence extract for metabolic dysfunction-associated steatohepatitis · Indication assessment
§3.3Type 2 diabetes mellitus
Anchor outcome. Change in HbA1c (%, mmol/mol).
Effect as recorded. −1.7 % HbA1c at 16 weeks in phase 2; phase 2.[3,4]
Certainty. Low certainty Short duration; the cardiovascular outcome trial was recruiting at this cycle.
Contributing trials. SYNCHRONIZE-CVOT. Full structured abstracts are published for each.
Full evidence extract for type 2 diabetes mellitus · Indication assessment
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
- Bhattacharyya S, Wang J, Kaplan RM. Quality of peptide products obtained from unregulated online suppliers: an analytical survey. Journal of Pharmaceutical Sciences 2024;113(4):1102–1110. doi:10.1016/j.xphs.2023.11.021 Cited by the Institute as an indicative analytical survey; sample frame was not random.
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