Status:
COMPLETED
This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Adolescents With Obesity
Eligibility:
All Genders
12-18 years
Phase:
PHASE1
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 mult...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06536023
Start Date
August 30 2024
End Date
August 1 2025
Last Update
September 12 2025
Active Locations (1)
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1
Beijing Children's Hospital, Capital Medical University Affiliated
Beijin, Beijin, China, 100045