Obesity (Silver Spring, Md.)

Survodutide as a treatment for obesity: reasons and plan for two large clinical trials

Updated

Abstract

A total of 1,481 participants will be evaluated in two multinational phase 3 clinical trials of survodutide for treatment.

  • SYNCHRONIZE-1 includes participants with a BMI ≥ 30 kg/m or ≥ 27 kg/m with at least one obesity-related complication but without type 2 diabetes.
  • SYNCHRONIZE-2 includes participants with a BMI ≥ 27 kg/m and type 2 diabetes.
  • Primary endpoints focus on the percentage change in body weight and the proportion of participants achieving a ≥5% body weight reduction from baseline to week 76.
  • Secondary endpoints assess changes in systolic blood pressure and measures of glycemia.
  • A substudy in SYNCHRONIZE-1 will evaluate changes in body composition and liver fat content using magnetic resonance imaging.

Simplified

Key numbers

726
Participants in SYNCHRONIZE-1
Total number of participants randomized in SYNCHRONIZE-1.
755
Participants in SYNCHRONIZE-2
Total number of participants randomized in SYNCHRONIZE-2.
76 weeks
Duration of trials
Length of treatment period for both trials.

Full Text

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Funding

Competing interests

Sean Wharton reports research funding from Novo Nordisk and Bausch Health Canada. He reports honoraria for academic talks and advisory board from Amgen, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Regeneron, Bausch Health Canada, Merck, iNova and Currax. Carel W. le Roux has received personal fees from Boehringer Ingelheim, GI Dynamics, Herbalife, Johnson & Johnson, Keyron, Eli Lilly, and Novo Nordisk outside the submitted work. Mikhail N. Kosiborod reports research grants (payments to institution) from Astra Zeneca, Boehringer Ingelheim, and Pfizer. He reports serving as a consultant on advisory boards (payments to institution) for 35Pharma, Alnylam, Amgen, Applied Therapeutics, Arrowhead Pharmaceuticals, Astra Zeneca, 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, Pharmaceuticals, Structure Therapeutics, Vifor Pharma, and Youngene Therapeutics. He reports other research support (Data Analytic Center Fees – payments to institution) from Astra Zeneca and Vifor Pharma. He reports receiving honoraria (payments to institution) from Astra Zeneca, Boehringer Ingelheim, and Novo Nordisk. He reports stock options (personal) from Artera Health and Saghmos Therapeutics. Elke Platz's employer has received support from Novartis for consulting work, and she has consulted for scPharmaceuticals. She has received research support from AstraZeneca, and she serves on the clinical trial steering committee of the SYNCHRONIZE‐1 and ‐2 trials and SYNCHRONIZE‐CVOT funded by Boehringer Ingelheim. Martina Brueckmann, Samina Ajaz Hussain, Luiza Borowska, Anna Unseld, and Isabel M. Kloer are employees of Boehringer Ingelheim. Ania M. Jastreboff conducts multicenter trials with Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Rhythm Pharmaceuticals and serves on scientific advisory boards for Amgen, AstraZeneca, Biohaven, Boehringer Ingelheim, Eli Lilly, Intellihealth, Novo Nordisk, Pfizer, Regeneron Pharmaceuticals, Scholar Rock, Structure Therapeutics, Terns Pharmaceuticals, WeightWatchers, and Zealand Pharma. Sue D. Pedersen declares personal fees for advisory board membership and speaking from Novo Nordisk, Janssen, Eli Lilly, Merck, Bausch Health, AstraZeneca, Abbott, Boehringer Ingelheim, Sanofi, HLS Therapeutics, and Dexcom; consulting fees from Novo Nordisk, Janssen, AstraZeneca, Abbott, HLS Therapeutics, and Dexcom; fees for clinical trials from Novo Nordisk, Eli Lilly, AstraZeneca, Sanofi, Prometic, and Pfizer; and grants from Eli Lilly, AstraZeneca, Abbott, Boehringer Ingelheim, and Sanofi. Lee M. Kaplan reports serving as a consultant to Altimmune, Amgen, AstraZeneca, Bain Capital, Boehringer Ingelheim, Cytoki, Gelesis, Gilead Sciences, Glyscend, Intellihealth, Johnson & Johnson, Kallyope, Eli Lilly, Novo Nordisk, Optum Health, Perspectum, Pfizer, Sidekick Health, Skye Bioscience, twenty30.health, Xeno Biosciences, and Zealand Pharma.
PubMed

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