Survodutide for treatment of obesity: Baseline characteristics of participants in a randomized, double‐blind, placebo‐controlled, phase 3 trial ( SYNCHRONIZE ™‐1)

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.