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RecruitingNCT07255209Updated Jan 8, 2026

A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

A Phase 3 interventional study of Placebo and IBI362 in Adolescents With Obesity or Overweight With Weight-Related Comorbidities, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Adolescents With Obesity or Overweight With Weight-Related Comorbidities
03

In context

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Participants must meet all of the following inclusion criteria to be enrolled:

Key Inclusion Criteria：

  1. Male or female participants aged ≥12 years and \<18 years at the time of signing the informed consent/assent form.
  2. BMI at screening meeting the obesity criteria defined by "WS/T 586-2018 Screening for Overweight and Obesity in School-Age Children and Adolescents" or meeting overweight criteria plus at least one weight-related comorbidity: prediabetes, type 2 diabetes, hypertension, dyslipidemia, fatty liver disease, or obstructive sleep apnea syndrome.
  3. Weight change \<5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report).

Exclusion criteria

Exclusion Criteria:

Key Exclusion Criteria：

  1. Prior diagnosis of type 1 diabetes.
  2. Pre-pubertal participants (Tanner Stage I).
  3. History of (or planned) bariatric surgery (except liposuction/abdominoplasty or acupuncture for weight loss performed >1 year before screening).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    IBI362-dose2

    Drug: IBI362

  • Experimental
    IBI362-dose1

    Drug: IBI362

Interventions

  • DrugPlacebo

    Placebo SA.QW

  • DrugIBI362

    IBI362 SA.QW

06

What researchers measure

Primary outcomes

  1. Percent Change from Baseline in BMI

    Time frame: Week 32

Secondary outcomes

  1. Percentage of Participants with ≥5% BMI Reduction

    Time frame: Week 32

  2. Percent Change from Baseline in BMI

    Time frame: Week 52

  3. Percentage of Participants with ≥5% BMI Reduction

    Time frame: Week 52

07

Study locations

1 of 1 sites recruiting
  • The Children's Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310052, China
    • Junfen Fu · Contact · fjf68@zju.edu.cn · 13777457849
    • Junfen Fu, M.D · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07255209
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Dec 29, 2025
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Jan 8, 2026

Study contacts

Xiaoyan li
Contact
xiaoyan.li@innoventbio.com
18756032014

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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