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

Conditions

• Adolescents With Obesity

Eligibility Criteria

Sex

ALL

Age

12 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• IBI362 — DRUG
  IBI362 SA.QW
• IBI362 placebo — DRUG
  IBI362 placebo SA.QW

Study Details

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.

Key Dates

Start date

Aug 30, 2024

Status verified

Sep 2025

Primary completion

Jul 22, 2025

Completion

Aug 1, 2025

Study Design

Enrollment

36 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 362-dose1-4mg
  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).
• Experimental: 362-dose2-6mg
  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)
• Experimental: 362-dose3-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.

Primary Outcome Measure

Incidence of adverse events and serious adverse events [ Time Frame: up to week 20 ]