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

Phase 2

Completed

• Conditions: Overweight/ Obesity
• Interventions: Drug: IBI362; Other: placebo

• Registration Number: NCT04904913
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-27
• Study Start: 2021-06-08
• Primary Completion: 2023-03-29
• Study Completion: 2023-12-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

1. 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
2. History of at least one unsuccessful dietary effort to lose body weight

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Exclusion Criteria

1. Diabetes mellitus
2. Weight change > 5.0% after diet and exercise control for at least 12 weeks before screening
3. Have used or are currently using weight loss drugs within 3 months before screening
4. History of pancreatitis
5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
6. History of moderate to severe depression，or have a history of serious mental illness
7. Any lifetime history of a suicide attempt

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI362 low dose	IBI362	Low dose IBI362 administered subcutaneously (SC) once a week.
IBI362 moderate dose	IBI362	moderate dose IBI362 administered subcutaneously (SC) once a week.
placebo	placebo	placebo administered subcutaneously (SC) once a week.
IBI362 extra high dose	IBI362	extra high dose IBI362 administered subcutaneously (SC) once a week.
IBI362 high dose	IBI362	high dose IBI362 administered subcutaneously (SC) once a week.

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline ,week 24	Percent Change from Baseline in Body Weight

Secondary Outcome Measures

Name	Time	Method
Safety and mental health	Baseline to week 36( 12 weeks after the end of treatment)	Adverse events, hypoglycemic events, vital signs, physical examination, laboratory examination, ECG, -SSRS questionnaire, PHQ-9 questionnaire, etc
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)

Trial Locations

Locations (1)

Peking University people's hospital; 🇨🇳 Beijing, Beijing, China