Obesity
Conditions
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.
Interventions
DRUGIBI362
Once-weekly injections of gradually increased doses of IBI362
DRUGPlacebo
Once-weekly injections of volume-matched placebo
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight | Week 60 |
| Proportion of Participants who Achieve ≥5% Body Weight Reduction | Week 60 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of Participants who Achieve ≥10% Body Weight Reduction | 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 |
| Percent Change from Baseline in Triglycerides | Week 60 |
| Proportion of Participants who Achieve ≥15% Body Weight Reduction | Week 60 |
Countries
China
Outcome results
None listed