Introduction and Objective: Polycystic ovary syndrome (PCOS) is frequently accompanied by overweight/obesity, amplifying metabolic and reproductive dysfunction. While GLP-1/GIP dual agonists promote weight loss in overweight/obese, their efficacy and safety remain untested in PCOS. We examined the effects of HRS9531 on weight and menstrual frequency in Chinese overweight/obese with PCOS. Methods: In this single-center, randomized, double-blind, placebo-controlled trial, 45 Chinese women aged 18-40 years with PCOS (Rotterdam criteria), BMI 26.0-40.0 kg/m² and oligomenorrhea/amenorrhea in the prior 3 months were randomized 2:1 to receive once-weekly subcutaneous HRS9531 4.0 mg (titrated; n=30) or placebo (n=15) for 28 weeks. Co-primary endpoints were percent of weight change at week 28 and change in menstrual frequency (weeks 16-28). Results: Baseline characteristics were well balanced. At week 28, the mean percentage change in body weight was -21.38% with HRS9531 versus -8.97% with placebo, mean difference -11.98% (95% CI -18.01% to -5.95%, P=0.0002). Menstrual frequency rose by 1.11 vs 0.76 episodes/12 weeks, mean difference 0.33 episodes/12 weeks (95% CI -0.34 to 1.00, P=0.325). Additionally, the proportion of participants restored regular menses were 63.3% vs 46.7% (P = 0.193), waist circumference fell 16.73% vs 7.51% (P=0.0112) and sex hormone-binding globulin (SHBG) rose 20.80 vs 2.29 nmol/L (P=0.002). HRS9531 was well tolerated and all adverse reactions were mild. Conclusion: HRS9531 significantly reduced weight loss in overweight/obese patients with PCOS, and showed potential to improving menstrual frequency and regularity. Disclosure J. Li: None. H. Jiang: None.
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