Adolescents With Obesity
Conditions
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.
Interventions
DRUGIBI362
IBI362 SA.QW
DRUGIBI362 placebo
IBI362 placebo SA.QW
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects who are aged ≥12 years and \<18 years at the time of signing the informed consent; 2. 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; 3. 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); 4. Able to maintain a stable diet and exercise lifestyle during the study period; 5. 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
1. Prepubertal subjects (Tanner Stage I) 2. Subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies 3. Use of other weight-loss medications or treatments prior to screening 4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and serious adverse events | up to week 20 |
Secondary
| Measure | Time frame |
|---|---|
| Half-life (t1/2) of multi-dose of IBI362 | 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 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 |
| Area under the Curve (AUC) of multi-dose of IBI362 | 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 |
| Evaluate changes in subjects' blood pressure in mmHg relative to baseline | up to week 12 |
Countries
China
Outcome results
None listed