A Study of IBI362 in Chinese Adolescents With Obesity or Overweight
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-18
SponsorInnovent Biologics (Suzhou) Co. Ltd.
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Placebo
- IBI362
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov