Clinical trial NCT06164873: A Study of IBI362 9 mg in Chinese Adults With Obesity
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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;

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Week 60
measure: Proportion of Participants who Achieve ≥5% Body Weight Reduction
timeFrame: Week 60
Secondary outcomes:
measure: Proportion of Participants who Achieve ≥10% Body Weight Reduction
timeFrame: Week 60
measure: Proportion of Participants who Achieve ≥15% Body Weight Reduction
timeFrame: Week 60
measure: Proportion of Participants who Achieve ≥20% Body Weight Reduction
timeFrame: Week 60
measure: Change from Baseline in Waist Circumference
timeFrame: Week 60
measure: Change from Baseline in Systolic Blood Pressure
timeFrame: Week 60
measure: Percent Change from Baseline in Triglycerides
timeFrame: Week 60
measure: Percent Change from Baseline in non-high-density lipoprotein cholesteroal
timeFrame: Week 60
measure: Percent Change from Baseline in low-density lipoprotein cholesterol
timeFrame: Week 60
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: