A Study of IBI362 9 mg in Chinese Adults With Obesity

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: IBI362

• Study Type: Interventional
• Enrollment (Actual): 462
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Once-weekly injections of volume-matched placebo
Experimental: IBI362	Drug: IBI362; Once-weekly injections of gradually increased doses of IBI362

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change from Baseline in Body Weight	Week 60
Proportion of Participants who Achieve ≥5% Body Weight Reduction	Week 60

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Participants who Achieve ≥10% Body Weight Reduction	Week 60
Proportion of Participants who Achieve ≥15% Body Weight Reduction	Week 60
Proportion of Participants who Achieve ≥20% Body Weight Reduction	Week 60
Change from Baseline in Waist Circumference	Week 60
Change from Baseline in Systolic Blood Pressure	Week 60
Percent Change from Baseline in Triglycerides	Week 60
Percent Change from Baseline in non-high-density lipoprotein cholesteroal	Week 60
Percent Change from Baseline in low-density lipoprotein cholesterol	Week 60

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): June 27, 2025
• Study Completion (Estimated): September 19, 2025

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: CIBI362B302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No