Survodutide for Obesity in Chinese Adults: Phase 3 Randomized Trial Design and Baseline Characteristics (SYNCHRONIZE™-CN).

INTRODUCTION

We aimed to describe the rationale, design, and overall baseline characteristics of the trial evaluating the efficacy, safety, and tolerability of survodutide in Chinese adults with overweight or obesity (SYNCHRONIZE™-CN, NCT06214741).

METHODS

In this 76-week, multicenter, randomized, double-blind, placebo-controlled, phase 3 trial, Chinese participants were randomized 1:1:1 to once-weekly subcutaneous survodutide (3.6 mg or 4.8 mg) or placebo plus lifestyle intervention. Participants with either body mass index (BMI) ≥ 28 kg/m2 or BMI ≥ 24 kg/m2 and at least one obesity-related complication were eligible. The primary endpoints were the percentage change in body weight and achievement of body weight reduction ≥ 5% from baseline to week 52.

RESULTS

At baseline, participants (N = 306) had a mean age of 36.9 years, body weight 93.9 kg, waist circumference 105.6 cm, BMI 33.2 kg/m2, triglycerides 2.2 mmol/L. 49% were women. 72.9% had at least one obesity-related complication, with metabolic dysfunction‑associated steatotic liver disease (48.4%), dyslipidemia (42.2%), hypertension (27.8%), and type 2 diabetes mellitus (16.7%) being the most prevalent, followed by obstructive sleep apnea (4.6%) and cardiovascular diseases (4.2%). In total, 19.6% had prediabetes.

CONCLUSIONS

This trial was designed to provide a robust evaluation of efficacy and safety of survodutide for the treatment of obesity or overweight in Chinese adults.

TRIAL REGISTRATION: Clinical Trials.gov identifier, NCT06214741.