A Study of IBI362 in Chinese Adolescents With Obesity or Overweight

NCT07255209 — Phase 3, Recruiting, 180 participants, Innovent Biologics (Suzhou) Co. Ltd.

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A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of IBI362 in Chinese Adolescents With Obesity or Overweight（GLORY-YOUNG）

Registry	NCT07255209
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, sequential, masking: double, treatment
Enrollment	180 (Estimated)
Sponsor	Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Conditions	Adolescents With Obesity or Overweight With Weight-Related Comorbidities
Interventions	Placebo, IBI362 (Drug)
Dates	start 2025-12-29, primary completion 2027-10-31 (estimated), completion 2028-10-31 (estimated), first posted 2025-11-28, last updated 2026-01-08
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions
Placebo	Placebo comparator	Drug: Placebo
IBI362-dose2	Experimental	Drug: IBI362
IBI362-dose1	Experimental	Drug: IBI362

Placebo (Drug): Placebo SA.QW
IBI362 (Drug): IBI362 SA.QW

+Outcome measures

Primary outcomes

Percent Change from Baseline in BMI [Week 32]

Secondary outcomes

Percentage of Participants with ≥5% BMI Reduction [Week 32]
Percent Change from Baseline in BMI [Week 52]
Percentage of Participants with ≥5% BMI Reduction [Week 52]

+Eligibility

Sex: All, ages: 12 Years to 18 Years

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:

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).

+Locations (1)

Facility	City	Country	Status
The Children's Hospital, Zhejiang University School of Medicine	Hangzhou, Zhejiang	China	Recruiting