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Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE-1 and -2) : clinical trials and investigations

Objective The objective of this study was to describe the rationale and design of two multinational phase 3 clinical trials of survodutide, an investigational glucagon and glucagon-like peptide-1 receptor dual agonist for the treatment of obesity with or without type 2 diabetes (T2D; SYNCHRONIZE-1 a...

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Main Authors: Wharton, Sean (Author) , le Roux, Carel W. (Author) , Kosiborod, Mikhail N. (Author) , Platz, Elke (Author) , Brückmann, Martina (Author) , Jastreboff, Ania M. (Author) , Ajaz Hussain, Samina (Author) , Pedersen, Sue D. (Author) , Borowska, Luiza (Author) , Unseld, Anna (Author) , Kloer, Isabel M. (Author) , Kaplan, Lee M. (Author)
Format: Article (Journal)
Language:English
Published: January 2025
In: Obesity
Year: 2025, Volume: 33, Issue: 1, Pages: 67-77
ISSN:1930-739X
DOI:10.1002/oby.24184
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1002/oby.24184
Verlag, kostenfrei, Volltext: http://onlinelibrary.wiley.com/doi/abs/10.1002/oby.24184
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Author Notes:Sean Wharton, Carel W. le Roux, Mikhail N. Kosiborod, Elke Platz, Martina Brueckmann, Ania M. Jastreboff, Samina Ajaz Hussain, Sue D. Pedersen, Luiza Borowska, Anna Unseld, Isabel M. Kloer, Lee M. Kaplan, on behalf of the SYNCHRONIZE-1 and -2 trial committees and investigators
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Summary:Objective The objective of this study was to describe the rationale and design of two multinational phase 3 clinical trials of survodutide, an investigational glucagon and glucagon-like peptide-1 receptor dual agonist for the treatment of obesity with or without type 2 diabetes (T2D; SYNCHRONIZE-1 and -2). Methods In these ongoing double-blind trials, participants were randomized to once-weekly subcutaneous injections of survodutide or placebo added to lifestyle modification. Survodutide doses are uptitrated to 3.6 or 6.0 mg, and dose flexibility is permitted. Participants (n = 726) in SYNCHRONIZE-1 (NCT06066515) have a baseline BMI ≥ 30 kg/m2 or ≥27 kg/m2 with at least one obesity-related complication but without T2D; participants (n = 755) in SYNCHRONIZE-2 (NCT06066528) have a baseline BMI ≥ 27 kg/m2 and T2D. The primary endpoints are percentage change in body weight and proportion of participants achieving ≥5% body weight reduction from baseline to week 76. Secondary endpoints include change in systolic blood pressure and measures of glycemia. A SYNCHRONIZE-1 substudy is evaluating changes in body composition and liver fat content using magnetic resonance imaging. Conclusions These trials are designed to provide robust evaluation of the efficacy, safety, and tolerability of survodutide for the treatment of obesity in the presence or absence of T2D.
Item Description:Erstmals veröffentlicht: 04. November 2024
Gesehen am 13.05.2025
Physical Description:Online Resource
ISSN:1930-739X
DOI:10.1002/oby.24184

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