667-P: IBI362 (LY3305677), a Weekly-Dose Glucagon-Like Peptide-1/Glucagon Receptor Dual Agonist, in Subjects with Overweight or Obesity

Objectives: The aim of this randomized, double-blind, placebo-controlled, dose-escalation study was to evaluate the safety, tolerability and efficacy of IBI362 in Chinese subjects with overweight or obesity. Methods: Overall, 36 Chinese subjects with obesity or overweight with complications were enrolled in three cohorts (12 subjects in each cohort) and randomized (2:1) to receive once-weekly subcutaneous injection of IBI362 or placebo for 12 weeks with 8 weeks of follow-up. The dose-escalation regimens were: cohort 1 (1 mg weeks 1-4; 2 mg weeks 5-8; 3 mg weeks 9-12); cohort 2 (1.5 mg weeks 1-4; 3 mg weeks 5-8; 4.5 mg weeks 9-12); cohort 3 (2 mg weeks 1-4; 4 mg weeks 5-8; 6 mg weeks 9-12). Endpoints included incidence of adverse events (AEs) and the body weight change from baseline. Results: Through the study, no subject discontinued the treatment due to safety reason and no severe AE was reported. The most commonly reported AEs in IBI362 treatment groups were gastrointestinal disorders, which mostly occurred in the first two weeks of each dose. Greater improvements were achieved with IBI362 versus placebo in body weight, waist circumference, BMI, blood pressure and lipids. Results were summarized in Table. Conclusions: IBI362 was well tolerated and showed a significant body weight-lowering effect and improved metabolic profiles in Chinese subjects with overweight or obesity. Disclosure H. Jiang: None. P. An: Employee; Self; innovent biological. H. Deng: Employee; Self; Innovent. L. Li: Employee; Self; Innovent biologics. L. Feng: None. Q. Ma: Employee; Self; Innovent Biologics. L. Qian: Employee; Self; Innoventbio. L. Ji: None.