Clinical trial
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)
Name
CIBI362B302
Description
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.
Trial arms
Trial start
2023-12-27
Estimated PCD
2025-06-27
Trial end
2025-09-19
Status
Recruiting
Phase
Early phase I
Treatment
IBI362
Once-weekly injections of gradually increased doses of IBI362
Arms:
IBI362
Placebo
Once-weekly injections of volume-matched placebo
Arms:
Placebo
Size
450
Primary endpoint
Percent Change from Baseline in Body Weight
Week 60
Proportion of Participants who Achieve ≥5% Body Weight Reduction
Week 60
Eligibility criteria
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;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}
Updated at
2024-05-01
1 organization
2 products
1 indication
Organization
Innovent Biologics (Suzhou)Product
IBI362Indication
ObesityProduct
Placebo