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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
IBI362 SA.QW
IBI362 placebo SA.QW
Beijing Children's Hospital, Capital Medical University Affiliated
Beijin, Beijin, China
Incidence of adverse events and serious adverse events
Time frame: up to week 20
Area under the Curve (AUC) of multi-dose of IBI362
Time frame: up to week 12
Half-life (t1/2) of multi-dose of IBI362
Time frame: up to week 12
Peak serum concentration (Cmax) of multi-dose of IBI362
Time frame: up to week 12
Clearance (CL) of multi-dose of IBI362
Time frame: 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
Time frame: up to week 12
Evaluate changes in subjects' waist-to-hip ratio(combined with waistline and hips) relative to baseline
Time frame: up to week 12
Evaluate changes in subjects' blood pressure in mmHg relative to baseline
Time frame: up to week 12
Evaluate changes in subjects' lipid profile in mmol/L relative to baseline
Time frame: up to week 12
Evaluate changes in subjects' glycated hemoglobin(Hemoglobin A1c,HbA1c)in % relative to baseline
Time frame: up to week 12
Evaluate the mental health status of subjects by Patient Health Questionnaire (PHQ-9) following administration of IBI362.
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Time frame: up to week 20
Evaluate the mental health status of subjects by Columbia-Suicide Severity Rating Scale (C-SSRS) following administration of IBI362.
Time frame: up to week 20