The SYNCHRONIZE-2 phase 3 trial enrolled a broad international cohort of people with obesity and type 2 diabetes to test for weight loss.
Evidence
This baseline report from a randomized phase 3 trial describes 752 treated participants across 133 sites in 19 countries, with planned 76-week body weight endpoints for weekly survodutide versus placebo.
Caveat
This paper reports baseline characteristics only and provides no efficacy, safety, or tolerability results yet.
Simplified
AIMS: 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 (BMI) ≥27 kg/mand 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. 2
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/m, 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. 2
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.
Key numbers
55.7 years
Mean Age
Average age of participants in SYNCHRONIZE-2 trial.
36.5 kg/m²
Mean
Average of participants at baseline.
69.0%
Hypertension Prevalence
Percentage of participants with hypertension at baseline.
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