A Study of IBI362 in Participants With Obesity or Overweight

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Obesity Or Overweight

Intervention / Treatment
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* Drug: Placebo
* Drug: IBI362


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, dyspnea or obstructive sleep apnea caused by obesity/overweight. Exclusion Criteria: Diabetes mellitus; 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 medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2); History of moderate to severe depression，or have a history of serious mental illness; Any lifetime history of a suicide attempt

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo,SC,once a week*48week | Drug: Placebo<br>* Placebo administered subcutaneously (SC) once a week.<br>|
| Experimental: IBI362 4.0mg<br>2mg,SC,once a week*4 week 4mg,SC,once a week*44 week | Drug: IBI362<br>* IBI362 administered subcutaneously (SC) once a week.<br>|
| Experimental: IBI362 6.0mg<br>2mg,SC,once a week*4 week 4mg,SC,once a week*4 week 6mg,SC,once a week*40 week | Drug: IBI362<br>* IBI362 administered subcutaneously (SC) once a week.<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 |  | Baseline, Week 32 | 
| Percentage of Participants who Achieve ≥5% Body Weight Reduction |  | Week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Achieve ≥10%Body Weight Reduction |  | Week 32 | 
| Percentage of Participants who Achieve ≥15% Body Weight Reduction |  | Week 32 | 
| Change from Baseline in Waist Circumference |  | Baseline, Week 32 | 
| Percent Change from Baseline in Body Weight |  | Baseline, Week 48 | 
| Percentage of Participants who Achieve ≥5% Body Weight Reduction |  | Week 48 | 
| Percentage of Participants who Achieve ≥10% Body Weight Reduction |  | Week 48 | 
| Percentage of Participants who Achieve ≥15% Body Weight Reduction |  | Week 48 |