A Study of IBI362 in Chinese Adolescents With Obesity or Overweight
Recruiting
Phase 3
Interventional Study
Adolescents With Obesity or Overweight With Weight-Related Comorbidities
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 180 (estimated)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
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About This Trial
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.
Trial Locations
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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…
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