A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

Study Overview
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Brief Summary
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This is a study of IBI362 in participants with overweight and obesity. The main purpose is to learn more about how IBI362 affects body weight. The study period including 4-8 weeks dose titration and 40-44 weeks maintain treatment and 12 weeks follow up.

Official Title
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A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects

Conditions
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Overweight/ Obesity

Intervention / Treatment
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* Drug: IBI362
* Other: placebo


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: hypertension, dyslipidemia, obstructive sleep apnea History of at least one unsuccessful dietary effort to lose body weight 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
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IBI362 high dose<br>high dose IBI362 administered subcutaneously (SC) once a week. | Drug: IBI362<br>* IBI362 administered subcutaneously (SC) once a week.<br>|
| Experimental: IBI362 low dose<br>Low dose IBI362 administered subcutaneously (SC) once a week. | Drug: IBI362<br>* IBI362 administered subcutaneously (SC) once a week.<br>|
| Placebo Comparator: placebo<br>placebo administered subcutaneously (SC) once a week. | Other: placebo<br>* placebo administered subcutaneously (SC) once a week.<br>|
| Experimental: IBI362 moderate dose<br>moderate dose IBI362 administered subcutaneously (SC) once a week. | Drug: IBI362<br>* IBI362 administered subcutaneously (SC) once a week.<br>|
| Experimental: IBI362 extra high dose<br>extra high dose IBI362 administered subcutaneously (SC) once a 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 | Percent Change from Baseline in Body Weight | Baseline ,week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and mental health | Adverse events, hypoglycemic events, vital signs, physical examination, laboratory examination, ECG, -SSRS questionnaire, PHQ-9 questionnaire, etc | Baseline to week 36( 12 weeks after the end of treatment) | 
| The percentage change of body weight relative to baseline |  | Baseline ，week 24( 24 weeks of continuous treatment) ，week 36( 12 weeks after the end of treatment) |