Overview
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
Eligibility
Inclusion Criteria:
- Male or female, age 18 years or older at the time of signing informed consent
- Have a BMI ≥30 kg/m2
- Have a history of at least one self-reported unsuccessful dietary effort to lose body weight
For subjects with T2D at screening:
- Have a diagnosis of T2D according to the WHO classification above or equal to 3 months prior to the day of screening
- Treated with either diet and excercise alone or on stable treatment with up to 3 oral antidiabetic medications alone or in any combination (EXCEPT GLP-1R agonists or DPP-4 inhibitors) for at least 2 months prior to the day of screening
- HbA1c 7.0-10.0% (both inclusive) at screening
- Fasting blood glucose ≤11.1 mmol/L at screening
Exclusion Criteria:
• A self-reported change in body weight above 5% within 3 months before screening
For subjects without T2D at screening:
• HbA1c ≥6.5% as measured by local laboratory at screening
For subjects with T2D at screening:
- Have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment
- Have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;