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The study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of IBI362 in Chinese adolescent subjects with obesity. It employs a multicenter, randomized, double-blind, and placebo-controlled trial design. The study plans to enroll 36 adolescents (aged ≥12 years and <18 years) with obesity who have experienced less than a 5% decrease in Body Mass Index (BMI) after at least 12 weeks of diet and exercise control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 362-dose1-4mg | Experimental | The starting dose for the subjects is 2 mg, administered once weekly for 4 consecutive weeks. If the subject shows good tolerability, the dose will then be escalated to 4 mg, also given once weekly, for another 8 weeks (with an escalation rate of increasing 2 mg every 4 weeks until reaching the target dose). |
|
| 362-dose2-6mg | Experimental | Subjects start at a dose of 2 mg, administered once weekly for 4 consecutive weeks. Following this, if the subject demonstrates good tolerability#, the dose will be escalated to 4 mg, also administered once weekly, for another 4 weeks. After observing the subject's tolerability again, if it remains favorable#, the dose will be further escalated to 6 mg, administered once weekly, for another 4 weeks (dosing will increase by 2 mg every 4 weeks until reaching the target dose of 6 mg) |
|
| 362-dose3-Placebo | Experimental | Administration is via subcutaneous injection once weekly; the mode and form of placebo administration are consistent with those of IBI362, with continuous dosing over a 12-week period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI362 | Drug | IBI362 SA.QW |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and serious adverse events | up to week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Curve (AUC) of multi-dose of IBI362 | up to week 12 | |
| Half-life (t1/2) of multi-dose of IBI362 | up to week 12 | |
| Peak serum concentration (Cmax) of multi-dose of IBI362 |
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Inclusion Criteria:
Exclusion Criteria:
Prepubertal subjects (Tanner Stage I)
Subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies
Use of other weight-loss medications or treatments prior to screening
Evidence or history of other medical conditions prior to screening:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University Affiliated | Beijin | Beijin | 100045 | China |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| IBI362 placebo |
| Drug |
IBI362 placebo SA.QW |
|
| up to week 12 |
| Clearance (CL) of multi-dose of IBI362 | up to week 12 |
| Evaluate changes in subjects' fasting body weight in kilograms,Body Mass Index in kg/m2(BMI, combined with weight and height) relative to baseline | up to week 12 |
| Evaluate changes in subjects' waist-to-hip ratio(combined with waistline and hips) relative to baseline | up to week 12 |
| Evaluate changes in subjects' blood pressure in mmHg relative to baseline | up to week 12 |
| Evaluate changes in subjects' lipid profile in mmol/L relative to baseline | up to week 12 |
| Evaluate changes in subjects' glycated hemoglobin(Hemoglobin A1c,HbA1c)in % relative to baseline | up to week 12 |
| Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362. | up to week 20 |
| Evaluate the mental health status of subjects by Columbia-Suicide Severity Rating Scale (C-SSRS) following administration of IBI362. | up to week 20 |