A Study of IBI362 in Chinese Adolescents With Obesity or Overweight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, IBI362.
- Who it may be relevant to
- Registry conditions: Adolescents With Obesity or Overweight With Weight-Related Comorbidities. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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）
Overview
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.
Interventions
- Drug Placebo
Placebo SA.QW - Drug IBI362
IBI362 SA.QW
Primary outcome measures
- Percent Change from Baseline in BMI [Time frame: Week 32]
Secondary outcome measures (3)
- Percentage of Participants with ≥5% BMI Reduction [Time frame: Week 32]
- Percent Change from Baseline in BMI [Time frame: Week 52]
- Percentage of Participants with ≥5% BMI Reduction [Time frame: Week 52]
Eligibility criteria
Inclusion criteria
Participants must meet all of the following inclusion criteria to be enrolled:
Key Inclusion Criteria：
- Male or female participants aged ≥12 years and <18 years at the time of signing the informed consent/assent form.
- 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.
- Weight change <5 kg after ≥12 weeks of diet and exercise alone before screening (per self/parental report).
Exclusion criteria
Key Exclusion Criteria：
- Prior diagnosis of type 1 diabetes.
- Pre-pubertal participants (Tanner Stage I).
- History of (or planned) bariatric surgery (except liposuction/abdominoplasty or acupuncture for weight loss performed >1 year before screening).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Children's Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07255209 · CIBI362B304