Status:
ACTIVE_NOT_RECRUITING
A Study of IBI362 9 mg in Chinese Adults With Obesity
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 IB...
Eligibility Criteria
Inclusion
- 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
- • 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;
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2025
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT06164873
Start Date
December 27 2023
End Date
September 19 2025
Last Update
August 27 2024
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010