This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of IBI362 in Chinese Obese Adolescent Subjects

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.

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