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A Study of IBI362 in Participants With Obesity or Overweight

Primary Purpose

Obesity Or Overweight

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Placebo
IBI362
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity Or Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • People's Hospital of Peking University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

IBI362 4.0mg

IBI362 6.0mg

Arm Description

Placebo,SC,once a week*48week

2mg,SC,once a week*4 week 4mg,SC,once a week*44 week

2mg,SC,once a week*4 week 4mg,SC,once a week*4 week 6mg,SC,once a week*40 week

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Body Weight
Percentage of Participants who Achieve ≥5% Body Weight Reduction

Secondary Outcome Measures

Percentage of Participants who Achieve ≥10%Body Weight Reduction
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Change from Baseline in Waist Circumference
Percent Change from Baseline in Body Weight
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Percentage of Participants who Achieve ≥15% Body Weight Reduction

Full Information

First Posted
October 23, 2022
Last Updated
June 2, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05607680
Brief Title
A Study of IBI362 in Participants With Obesity or Overweight
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2022 (Actual)
Primary Completion Date
January 12, 2024 (Anticipated)
Study Completion Date
April 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Or Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo,SC,once a week*48week
Arm Title
IBI362 4.0mg
Arm Type
Experimental
Arm Description
2mg,SC,once a week*4 week 4mg,SC,once a week*44 week
Arm Title
IBI362 6.0mg
Arm Type
Experimental
Arm Description
2mg,SC,once a week*4 week 4mg,SC,once a week*4 week 6mg,SC,once a week*40 week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered subcutaneously (SC) once a week.
Intervention Type
Drug
Intervention Name(s)
IBI362
Intervention Description
IBI362 administered subcutaneously (SC) once a week.
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Body Weight
Time Frame
Baseline, Week 32
Title
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time Frame
Week 32
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve ≥10%Body Weight Reduction
Time Frame
Week 32
Title
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Time Frame
Week 32
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline, Week 32
Title
Percent Change from Baseline in Body Weight
Time Frame
Baseline, Week 48
Title
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Time Frame
Week 48
Title
Percentage of Participants who Achieve ≥10% Body Weight Reduction
Time Frame
Week 48
Title
Percentage of Participants who Achieve ≥15% Body Weight Reduction
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
People's Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

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A Study of IBI362 in Participants With Obesity or Overweight

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