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

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Adolescents With Obesity

Treatments: Drug: IBI362 placebo; Drug: IBI362

Study type: Interventional

Funder types: Industry

Identifiers

NCT06536023

CIBI362B103

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 3 patient groups

362-dose1-4mg

Experimental group

Description:

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).

Treatment:

Drug: IBI362

362-dose2-6mg

Experimental group

Description:

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)

Treatment:

Drug: IBI362

362-dose3-Placebo

Experimental group

Description:

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.

Treatment:

Drug: IBI362 placebo