Survodutide for the Treatment of Obesity Disease in Japanese Participants: Rationale, Design and Baseline Characteristics of the Phase 3 SYNCHRONIZE ‐ JP Trial

ABSTRACT Aims There is an unmet need for effective pharmacotherapy for obesity disease management in Japan. Survodutide is a novel glucagon receptor/glucagon‐like peptide‐1 receptor (GLP‐1R) dual agonist with the potential to induce greater weight reductions than GLP‐1R mono‐agonists. We report the design and baseline participant characteristics of the SYNCHRONIZE‐JP trial evaluating survodutide in Japanese adults with obesity disease ( ClinicalTrials.gov : NCT06176365). Materials and Methods SYNCHRONIZE‐JP is a 76‐week, randomised, double‐blind, parallel‐group, multi‐centre, phase 3 clinical trial. Eligible participants were aged ≥ 18 years, with BMI ≥ 35 kg/m 2 with ≥ 1 obesity complication or BMI ≥ 27 kg/m 2 with ≥ 2 obesity complications, ≥ 1 self‐reported unsuccessful dietary effort to lose body weight and ≥ 1 obesity complication required to be type 2 diabetes (T2D; capped at 30% enrolment), hypertension or dyslipidaemia. Participants were randomised 1:1:1 to receive once‐weekly survodutide 3.6 or 6.0 mg, or placebo, accompanied by a reduced‐calorie diet and increased physical activity. The primary endpoints are percentage change in body weight and achievement of body weight reduction ≥ 5% from baseline to Week 76. A subset of participants will be assessed for additional endpoints of liver fat content and body composition. Results Of 274 enrolled participants, 24.1% had T2D. The mean age was 53.1 years; 47.8% were female, and mean BMI was 33.2 kg/m 2 . The most frequent complications were dyslipidaemia (81.4%), hypertension (72.6%), hyperuricaemia (30.3%) and metabolic dysfunction‐associated steatotic liver disease (26.6%). Conclusions The results of SYNCHRONIZE‐JP will provide Japan‐specific efficacy, safety and tolerability data for survodutide and inform its potential role in the management of obesity disease.