111-OR: Effect of Dulaglutide plus Calorie-Restricted Diet vs. Calorie-Restricted Diet on Visceral Fat and Metabolic Profiles in Women with Polycystic Ovary Syndrome—A Randomized Controlled Trial

This study investigated whether dulaglutide combined with CRD could further reduce VAT and promote clinical benefits compared with the CRD regimen alone in overweight or obese women with PCOS. This single-center, randomized, controlled, open-label clinical trial was conducted between May 2021 and May 2022. Overall, 243 patients were screened, of which 68 overweight or obese women with PCOS were randomly assigned to receive dulaglutide combined with CRD treatment (n=35) or CRD treatment alone (n=33). The duration of intervention was set as the time taken to achieve a 7% weight loss goal from baseline body weight, which was restricted to 6 months. The primary endpoint was the difference in the change in VAT area reduction between the groups. The secondary endpoints contained changes in menstrual frequency, metabolic profiles, hormonal parameters, liver fat, and body composition. The mean time to achieve 7% weight loss was significantly shorter in the dulaglutide+CRD group than in the CRD group. There was no significant between-group difference in the change in VAT reduction (-0.97 cm2, 95% confidence interval, -14.36-12.42; P=0.884). Compared to CRD alone, dulaglutide+CRD had significant advantages in reducing glycated hemoglobin A1c and postprandial plasma glucose levels. Results of analyses of changes in menstrual frequency, other metabolic profiles, hormonal parameters, liver fat, and body composition were not significantly different between the two groups. Nausea, vomiting, constipation, and loss of appetite were the main adverse events of dulaglutide. These findings support the importance of dietary intervention as first-line management in women with PCOS, and glucagon-like peptide 1 receptor agonist (GLP-1 RA) therapy offers an effective and generally tolerable adjunct therapy to aid in achieving weight target based on dietary therapy in overweight/obese women with PCOS. Disclosure Y.Zhang: None. X.Shao: None. M.Cai: None. D.Dilimulati: None. S.Qu: None. M.Zhang: None. Funding National Natural Science Foundation of China (81601269)