Mazdutide — 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. −14.4 % body weight at 48 weeks with 6 mg in a Chinese phase 3 trial versus −0.3 % with placebo; estimated difference −14.1 percentage points (95 % CI −15.7 to −12.5).[1,2]
Certainty. Moderate certainty Phase 3 conducted predominantly in a Chinese population. Downgraded one level for indirectness when applied to other populations, since baseline body weight and body composition differ substantially from the Western pivotal programmes.
Contributing trials. GLORY-1 · DREAMS-1 · MAZ-PH2-OBESITY. Full structured abstracts are published for each.
Full evidence extract for obesity and overweight in adults · Indication assessment
§3.2Type 2 diabetes mellitus
Anchor outcome. Change in HbA1c (%, mmol/mol).
Effect as recorded. −1.8 % HbA1c at 24 weeks with 6 mg; estimated difference −1.6 % (95 % CI −1.9 to −1.3).[2,3]
Certainty. Moderate certainty Phase 3 in a Chinese population.
Contributing trials. DREAMS-2 · DREAMS-3. 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.
- Ji L, Jiang H, Bi Y, Li X, Ning G, Qu S, Wu Y, Yang J, Chen L, Li L, Zhang M, Qian L. Efficacy and safety of mazdutide in Chinese participants with overweight or obesity: a randomised, double-blind, placebo-controlled phase 2 trial. Diabetes, Obesity and Metabolism 2023;25(12):3691–3700. doi:10.1111/dom.15264
- 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
- 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
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