A Study of IBI362 9 mg in Chinese Adults With Obesity

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of IBI362 9 mg in Chinese Participants With Obesity (GLORY-2)

Conditions
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Obesity

Intervention / Treatment
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* Drug: IBI362
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 On stable treatment for at least 2 months prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (EXCEPT GLP-1R agonists, DPP-4 inhibitors or SU) HbA1c 7.5-10.0% (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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Once-weekly injections of volume-matched placebo<br>|
| Experimental: IBI362<br> | Drug: IBI362<br>* Once-weekly injections of gradually increased doses of IBI362<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline in Body Weight |  | Week 60 | 
| Proportion of Participants who Achieve ≥5% Body Weight Reduction |  | Week 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants who Achieve ≥10% Body Weight Reduction |  | Week 60 | 
| Proportion of Participants who Achieve ≥15% Body Weight Reduction |  | Week 60 | 
| Proportion of Participants who Achieve ≥20% Body Weight Reduction |  | Week 60 | 
| Change from Baseline in Waist Circumference |  | Week 60 | 
| Change from Baseline in Systolic Blood Pressure |  | Week 60 | 
| Percent Change from Baseline in Triglycerides |  | Week 60 | 
| Percent Change from Baseline in non-high-density lipoprotein cholesteroal |  | Week 60 | 
| Percent Change from Baseline in low-density lipoprotein cholesterol |  | Week 60 |