A Study of IBI362 in Participants With Obesity or Overweight

A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of IBI362 in Chinese Participants With Obesity or Overweight (GLORY-1)

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Inclusion Criteria:

• Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.

Exclusion Criteria:

• HbA1c ≥ 6. 5% at screening or previous diagnosis of type 1 or type 2 diabetes;
• Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening;
• Have used or are currently using weight loss drugs within 3 months before screening;
• History of pancreatitis;
• Family or personal history of thyroid C-cell carcinoma or multiple endocrine neoplasia (MEN) 2A or 2B；
• History of moderate to severe depression or severe mental illness;
• Any lifetime history of a suicide attempt