Publication Date
1-1-2026
Journal
Diabetes, Obesity and Metabolism
DOI
10.1111/dom.70196
PMID
41187967
PMCID
PMC12673442
PubMedCentral® Posted Date
11-4-2025
PubMedCentral® Full Text Version
Post-print
Abstract
Aims: Survodutide, a novel glucagon receptor and glucagon-like peptide-1 (GLP-1) receptor dual agonist, elicited significant weight loss in a phase 2 trial in individuals with obesity without type 2 diabetes (T2D). Two multinational phase 3 trials are investigating survodutide for obesity management in individuals with or without T2D. We report the baseline characteristics of participants in the SYNCHRONIZE-1 trial in adults with obesity without T2D (ClinicalTrials.gov: NCT06066515).
Materials and methods: Participants aged ≥18 years with BMI ≥30 or ≥27 kg/m2 with ≥1 obesity complication without T2D were randomized 1:1:1 to double-blind, once-weekly, subcutaneous injections of survodutide (up-titrated to 3.6 or 6.0 mg) or placebo for 76 weeks. The primary endpoints are percent body weight change and achievement of body weight reduction ≥5% from baseline to Week 76. Efficacy and safety analyses will include all randomized and treated participants.
Results: At baseline, participants (n = 725 from 14 countries) had a mean age of 47.1 years, BMI 37.9 kg/m2, and waist circumference 115.2 cm. Most participants (59.4%) were female; 47.3% were from North America, 21.0% from Europe, and 20.0% from East Asia. Obesity complications included hypertension (40.0%), dyslipidaemia (33.7%), and prediabetes (30.2%). Mean haemoglobin A1c was 5.5%, estimated glomerular filtration rate 93.0 mL/min/1.73 m2, systolic/diastolic blood pressure 127.0/82.7 mmHg, and low-density lipoprotein cholesterol 116.4 mg/dL; 21.8% were taking lipid-lowering drugs.
Conclusions: SYNCHRONIZE-1 will determine the efficacy, safety, and tolerability of survodutide, a glucagon receptor/GLP-1 receptor dual agonist, for weight loss in a representative cohort of people with obesity without T2D.
Keywords
Humans, Double-Blind Method, Obesity, Female, Male, Middle Aged, Adult, Weight Loss, Glucagon-Like Peptide-1 Receptor Agonists, Anti-Obesity Agents, Treatment Outcome, Aged, Diabetes Mellitus, Type 2, Injections, Subcutaneous, glucagon, glucagon‐like peptide‐1 receptor agonists, obesity, randomized controlled trial
Published Open-Access
yes
Recommended Citation
le Roux, Carel W; Wharton, Sean; Bozkurt, Biykem; et al., "Survodutide for Treatment of Obesity: Baseline Characteristics of Participants in a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial (Synchronize™-1)" (2026). Faculty, Staff and Students Publications. 6647.
https://digitalcommons.library.tmc.edu/baylor_docs/6647