DRUG
IBI362
Once-weekly injections of gradually increased doses of IBI362
Status
Active, not recruiting
Phase
Phase 3
Enrollment
462
Locations
1
Results
Not posted
Publications
1
Study 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 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.
Interventions
DRUG
Once-weekly injections of gradually increased doses of IBI362
DRUG
Once-weekly injections of volume-matched placebo
Timeline
First posted
Dec 11, 2023
Study start
Dec 27, 2023
Primary completion
Jun 27, 2025
Study completion
Sep 19, 2025
Results posted
Not reported
Registry updated
Aug 27, 2024
Outcomes
Percent Change from Baseline in Body Weight
Time frame · Week 60
Proportion of Participants who Achieve ≥5% Body Weight Reduction
Time frame · Week 60
Proportion of Participants who Achieve ≥10% Body Weight Reduction
Time frame · Week 60
Proportion of Participants who Achieve ≥15% Body Weight Reduction
Time frame · Week 60
Proportion of Participants who Achieve ≥20% Body Weight Reduction
Time frame · Week 60
Change from Baseline in Waist Circumference
Time frame · Week 60
Change from Baseline in Systolic Blood Pressure
Time frame · Week 60
Percent Change from Baseline in Triglycerides
Time frame · Week 60
Percent Change from Baseline in non-high-density lipoprotein cholesteroal
Time frame · Week 60
Percent Change from Baseline in low-density lipoprotein cholesterol
Time frame · Week 60
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;
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Peking University People's Hospital
Beijing, Beijing Municipality, China
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