A Study of IBI362 9 mg in Chinese Adults With Obesity

Obesity Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of IBI362 9 mg in Chinese Participants With Obesity (GLORY-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164873
• Other study ID #: CIBI362B302
• Status: Recruiting
• Phase: Phase 3
• Start date: December 27, 2023
• Est. completion date: September 19, 2025

Study information

• Verified date: April 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Linong Ji
• Phone: 13910978815
• Email: jiln[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 19, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, age 18 years or older at the time of signing informed consent

• Have a BMI =30 kg/m2

• Have a history of at least one self-reported unsuccessful dietary effort to lose body weight

For subjects with T2D at screening:

• Have a diagnosis of T2D according to the WHO classification above or equal to 3 months prior to the day of screening

• Treated with either diet and excercise alone or on stable treatment with up to 3 oral antidiabetic medications alone or in any combination (EXCEPT GLP-1R agonists or DPP-4 inhibitors) for at least 2 months prior to the day of screening

• HbA1c 7.0-10.0% (both inclusive) at screening

• Fasting blood glucose =11.1 mmol/L at screening

Exclusion Criteria:

• A self-reported change in body weight above 5% within 3 months before screening

For subjects without T2D at screening:

• HbA1c =6.5% as measured by local laboratory at screening

For subjects with T2D at screening:

• Have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment

• Have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• IBI362
Once-weekly injections of gradually increased doses of IBI362
• Placebo
Once-weekly injections of volume-matched placebo

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Body Weight		Week 60
Primary	Proportion of Participants who Achieve =5% Body Weight Reduction		Week 60
Secondary	Proportion of Participants who Achieve =10% Body Weight Reduction		Week 60
Secondary	Proportion of Participants who Achieve =15% Body Weight Reduction		Week 60
Secondary	Proportion of Participants who Achieve =20% Body Weight Reduction		Week 60
Secondary	Change from Baseline in Waist Circumference		Week 60
Secondary	Change from Baseline in Systolic Blood Pressure		Week 60
Secondary	Percent Change from Baseline in Triglycerides		Week 60
Secondary	Percent Change from Baseline in non-high-density lipoprotein cholesteroal		Week 60
Secondary	Percent Change from Baseline in low-density lipoprotein cholesterol		Week 60