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

Primary Purpose

Overweight/ Obesity

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IBI362
placebo
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight/ Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Peking University people's hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

IBI362 high dose

IBI362 low dose

placebo

IBI362 moderate dose

IBI362 extra high dose

Arm Description

high dose IBI362 administered subcutaneously (SC) once a week.

Low dose IBI362 administered subcutaneously (SC) once a week.

placebo administered subcutaneously (SC) once a week.

moderate dose IBI362 administered subcutaneously (SC) once a week.

extra high dose IBI362 administered subcutaneously (SC) once a week.

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Body Weight
Percent Change from Baseline in Body Weight

Secondary Outcome Measures

Safety and mental health
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

Full Information

First Posted
May 25, 2021
Last Updated
June 5, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04904913
Brief Title
A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects
Official Title
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
March 29, 2023 (Actual)
Study Completion Date
January 31, 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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBI362 high dose
Arm Type
Experimental
Arm Description
high dose IBI362 administered subcutaneously (SC) once a week.
Arm Title
IBI362 low dose
Arm Type
Experimental
Arm Description
Low dose IBI362 administered subcutaneously (SC) once a week.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo administered subcutaneously (SC) once a week.
Arm Title
IBI362 moderate dose
Arm Type
Experimental
Arm Description
moderate dose IBI362 administered subcutaneously (SC) once a week.
Arm Title
IBI362 extra high dose
Arm Type
Experimental
Arm Description
extra high dose IBI362 administered subcutaneously (SC) once a week.
Intervention Type
Drug
Intervention Name(s)
IBI362
Intervention Description
IBI362 administered subcutaneously (SC) once a week.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo administered subcutaneously (SC) once a week.
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Body Weight
Description
Percent Change from Baseline in Body Weight
Time Frame
Baseline ,week 24
Secondary Outcome Measure Information:
Title
Safety and mental health
Description
Adverse events, hypoglycemic events, vital signs, physical examination, laboratory examination, ECG, -SSRS questionnaire, PHQ-9 questionnaire, etc
Time Frame
Baseline to week 36( 12 weeks after the end of treatment)
Title
The percentage change of body weight relative to baseline
Time Frame
Baseline ，week 24( 24 weeks of continuous treatment) ，week 36( 12 weeks after the end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 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: 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
Facility Information:
Facility Name
Peking University people's hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

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

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