Survodutide for the Treatment of Obesity: Rationale and Design of the SYNCHRONIZE Cardiovascular Outcomes Trial.

Dual agonism of glucagon and glucagon-like peptide-1 (GLP-1) receptors may be more effective than GLP-1 receptor agonism alone in reducing body weight, but the cardiovascular (CV) effects are unknown. The authors describe the rationale and design of SYNCHRONIZE-CVOT, a phase 3, randomized, double-blind, parallel-group, event-driven, CV safety study of survodutide, a dual glucagon and GLP-1 receptor agonist, administered subcutaneously once weekly compared with placebo in adults with a body mass index ≥27 kg/m

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Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.

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Funding Support and Author Disclosures The SYNCHRONIZE-CVOT was funded by Boehringer Ingelheim. Dr Kosiborod has received research grants (payments to institution) from AstraZeneca, Boehringer Ingelheim, and Pfizer; has served as a consultant on advisory boards (payments to institution) for 35Pharma, Alnylam, Amgen, Applied Therapeutics, Arrowhead Pharmaceuticals, AstraZeneca, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Cytokinetics, Dexcom, Eli Lilly, Esperion Therapeutics, Imbria Pharmaceuticals, Janssen, Lexicon Pharmaceuticals, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pfizer, Pharmacosmos, Regeneron, Sanofi, scPharmaceuticals, Structure Therapeutics, Vifor Pharma, and Youngene Therapeutics; has received other research support (Data Analytic Center Fees – payments to institution) from AstraZeneca and Vifor Pharma; has received honoraria (payments to institution) from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk; and has received stock options (personal) from Artera Health and Saghmos Therapeutics. Dr Platz’s employer has received support from Novartis for consulting work; and she has consulted for scPharmaceuticals; has received research support from the National Institutes of Health, American Heart Association, and AstraZeneca; and has served on the clinical trial steering committee of the SYNCHRONIZE 1 and 2 trials and SYNCHRONIZE-CVOT funded by Boehringer Ingelheim. Dr Wharton has received research funding from Novo Nordisk and Bausch Health Canada; and has received honoraria for academic talks and advisory board from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Regeneron, Bausch Health Canada, Merck, iNova, and Currax. Dr le Roux has received grants from the EU Innovative Medicine Initiative, Irish Research Council, Science Foundation Ireland, Anabio, and the Health Research Board; serves on advisory boards and speakers panels of Novo Nordisk, Roche, Herbalife, GI Dynamics, Eli Lilly, Johnson & Johnson, Glia, Irish Life Health, Boehringer Ingelheim, Currax, Zealand Pharma, Keyron, AstraZeneca, Arrow Pharma, and Rhythm Pharma; is the Chair of the Irish Society for Nutrition and Metabolism; and he provides obesity clinical care in the My Best Weight clinic and Beyond BMI clinic and is a shareholder in these clinics. Drs Brueckmann, Startseva, and Ajaz Hussain are full-time employees of Boehringer Ingelheim International GmbH. Ms Unseld is a full-time employee of Boehringer Ingelheim Pharma GmbH and Co KG. Dr Kaplan has served as a consultant to Altimmune, Amgen, Bain Capital, Boehringer Ingelheim, Cytoki, Gelesis, Gilead Sciences, Glyscend, Intellihealth, Johnson and Johnson, Kallyope, Eli Lilly and Co, Novo Nordisk, Optum Health, Perspectum, Pfizer, Sidekick Health, Skye Bioscience, twenty30.health, and Xeno Biosciences. The authors meet criteria for authorship as recommended by the ICMJE (International Committee of Medical Journal Editors), were fully responsible for all content and editorial decisions, and were involved at all stages of manuscript development. The authors did not receive payment related to the development of this manuscript. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.