SYNCHRONIZE-1 is testing once-weekly survodutide for weight loss in adults with without type 2 diabetes.
Evidence
This randomized, double-blind, placebo-controlled phase 3 trial report describes baseline characteristics for 725 participants from 14 countries before 76 weeks of survodutide or placebo treatment.
Caveat
This abstract reports baseline trial data only, so efficacy, safety, and tolerability results are not yet available.
Simplified
AIMS: Survodutide, a novel receptor and glucagon-like peptide-1 (GLP-1) receptor dual agonist, elicited significant weight loss in a phase 2 trial in individuals with 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/mwith ≥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. 2
RESULTS: At baseline, participants (n = 725 from 14 countries) had a mean age of 47.1 years, BMI 37.9 kg/m, 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 m, 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. 2 2
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.
Key numbers
47.1 years
Mean Age of Participants
Mean age of 725 randomized participants
37.9 kg/m²
Mean BMI of Participants
Mean BMI of 725 randomized participants
59.4%
Percentage of Female Participants
Percentage of 725 randomized participants
Full Text
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