A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07255209
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Adolescents With Obesity or Overweight With Weight-Related Comorbidities

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo SA.QW
  • IBI362 — DRUG
    IBI362 SA.QW

Study Details

The study is designed to assess the efficacy and safety of multiple doses of IBI362 in Chinese adolescent subjects with obesity or overweight. It plans to enroll 180 adolescents (aged ≥12 and \<18 years) who have failed to achieve a 5 kg weight reduction after at least 12 weeks of dietary and exercise intervention.

Key Dates

Start date
Dec 29, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: IBI362-dose2
  • Experimental: IBI362-dose1

Primary Outcome Measure

Percent Change from Baseline in BMI [ Time Frame: Week 32 ]

Central Contacts