This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity
Phase 1
Active, not recruiting
- Conditions
- Adolescents With Obesity
- Interventions
- Drug: IBI362 placebo
- Registration Number
- NCT06536023
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Male or female subjects who are aged ≥12 years and <18 years at the time of signing the informed consent;
- At screening, the Body Mass Index (BMI) meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
- Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);
- Able to maintain a stable diet and exercise lifestyle during the study period;
- Capable of understanding the procedures and methods of this study, willing to strictly adhere to the clinical trial protocol to complete this trial, with both the subject and the parent or legal guardian voluntarily signing the informed consent form.
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:
- HbA1c ≥ 6.5% at screening or a previous diagnosis of Type 1 or Type 2 diabetes
- Presence of retinopathy at screening
- History of severe hypoglycemia or recurrent symptomatic hypoglycemia
- Obesity secondary to disease or medication, including hypercortisolism (e.g., Cushing's syndrome)
- Previous bariatric surgery
- History of moderate to severe depression; or history of serious psychiatric illness
- Previous suicidal ideation or suicide attempt
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 362-dose1-4mg IBI362 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-dose3-Placebo IBI362 placebo 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. 362-dose2-6mg IBI362 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)
- Primary Outcome Measures
Name Time Method Incidence of adverse events and serious adverse events up to week 20
- Secondary Outcome Measures
Name Time Method Area under the Curve (AUC) of multi-dose of IBI362 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' 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 Half-life (t1/2) 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' blood pressure in mmHg relative to baseline up to week 12 Peak serum concentration (Cmax) of multi-dose of IBI362 up to week 12 Clearance (CL) of multi-dose of IBI362 up to week 12 Evaluate the mental health status of subjects by Columbia-Suicide Severity Rating Scale (C-SSRS) following administration of IBI362. up to week 20
Trial Locations
- Locations (1)
Beijing Children's Hospital, Capital Medical University Affiliated
🇨🇳Beijin, Beijin, China