Language
English
Publication Date
2-1-2026
Journal
Diabetes, Obesity and Metabolism
DOI
10.1111/dom.70263
PMID
41216778
PMCID
PMC12803687
PubMedCentral® Posted Date
11-11-2025
PubMedCentral® Full Text Version
Post-print
Abstract
Aims: Survodutide is an investigational glucagon receptor/glucagon-like peptide-1 receptor dual agonist that has shown promise for treating obesity and its complications in Phase 2 trials. Two double-blind, randomized, global Phase 3 trials are designed to assess the efficacy and safety of survodutide for treatment of obesity-SYNCHRONIZE™-1 in people with obesity without type 2 diabetes (T2D) and SYNCHRONIZE™-2 in people with obesity and T2D. This paper describes the baseline characteristics of participants in SYNCHRONIZE-2 (ClinicalTrials.gov identifier NCT06066528).
Materials and methods: Participants aged ≥18 years with a body mass index (BMI) ≥27 kg/m2 and T2D were randomized 1:1:1 to weekly subcutaneous survodutide (up-titrated to 3.6 or 6.0 mg) or placebo with recommendations for modified diet and physical activity. The primary endpoints are the percentage change in body weight (BW) and achievement of BW reduction of ≥5% from baseline to Week 76.
Results: SYNCHRONIZE-2 includes 752 treated participants from 133 sites across 19 countries. At baseline, participants had a mean age of 55.7 years, BMI 36.5 kg/m2, BW 104.1 kg, waist circumference 115.5 cm and haemoglobin A1c 7.4%; 50.7% were female. Overall, 36.2% are from Europe, 32.8% from North America and 22.3% from East Asia. The most common obesity complications included hypertension (69.0%), dyslipidaemia (67.6%), obstructive sleep apnoea (17.3%) and arteriosclerotic cardiovascular disease (10.9%); 78.7% were treated with metformin, 34.2% with sodium-glucose co-transporter-2 inhibitors and 58.6% with lipid-lowering medications.
Conclusions: SYNCHRONIZE-2 will determine the efficacy, safety and tolerability of survodutide for BW reduction in people with obesity and T2D, whose baseline characteristics suggest a representative, diverse cohort.
Keywords
Humans, Diabetes Mellitus, Type 2, Female, Middle Aged, Male, Obesity, Double-Blind Method, Glucagon-Like Peptide-1 Receptor Agonists, Adult, Hypoglycemic Agents, Aged, Treatment Outcome, Weight Loss, Body Mass Index, Receptors, Glucagon, Anti-Obesity Agents, diabetes mellitus, type 2; glucagon; glucagon‐like peptide‐1 receptor agonists; obesity; randomized controlled trial
Published Open-Access
yes
Recommended Citation
Wharton, Sean; le Roux, Carel W; Bozkurt, Biykem; et al., "Baseline Characteristics in the Synchronize™-2 Randomized Phase 3 Trial of Survodutide, a Glucagon Receptor/Glp-1 Receptor Dual Agonist, for Obesity in People With Type 2 Diabetes" (2026). Faculty, Staff and Students Publications. 6640.
https://digitalcommons.library.tmc.edu/baylor_docs/6640