IBI362 for weight loss in Chinese adolescents with obesity or overweight

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）

This research will see if different doses of IBI362 help Chinese adolescents aged 12–17 with obesity or overweight and weight-related health problems lose weight after diet and exercise did not produce at least a 5 kg reduction.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07255209 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial plans to enroll about 180 Chinese adolescents aged 12 to under 18 who have not lost at least 5 kg after at least 12 weeks of diet and exercise. Eligible participants meet national criteria for obesity or are overweight with at least one weight-related comorbidity and will receive one of multiple doses of IBI362 or placebo. Participants will be monitored for changes in body weight and for safety outcomes throughout the treatment period. Key exclusions include prior type 1 diabetes, pre-pubertal status (Tanner Stage I), and recent bariatric surgery.

Who should consider this trial

Good fit: Adolescents aged 12 to under 18 in China who meet the WS/T 586-2018 obesity criteria or are overweight with at least one weight-related comorbidity and who did not lose ≥5 kg after ≥12 weeks of diet and exercise.

Not a fit: Patients with type 1 diabetes, pre-pubertal children (Tanner Stage I), or those with recent bariatric surgery are excluded and are unlikely to benefit from participation in this protocol.

Why it matters

Potential benefit: If successful, IBI362 could provide an additional medical option to help adolescents lose clinically meaningful weight when lifestyle changes alone have not worked.

How similar studies have performed: Other GLP-1–based weight-loss medications such as liraglutide and semaglutide have shown weight reduction in adolescents, so related pharmacologic approaches have demonstrated success, though IBI362 itself is still under evaluation.

Eligibility criteria

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).

Where this trial is running

Hangzhou, Zhejiang

• The Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyan li

Conditions Adolescents With Obesity or Overweight With Weight-Related Comorbidities