A Study of XW003 Injection in Chinese Adolescents With Obesity

In this study, eligible participants will be randomized into one of the three cohorts in a 3:1 ratio to receive either once-weekly subcutaneous XW003 injection or placebo, for up to 20 weeks.

Inclusion criteria

• At the time of screening, BMI meets the obesity criteria specified in WS/T586-2018 'screening for overweight and obesity among school-aged children and adolescents', and weight ≥55 kg;
• At the time of screening, the decrease of body mass index less than 5% after diet and exercise control alone for at least 12 weeks (as reported by participants or parents or legal guardians);

Exclusion criteria

• Pre-adolescent participants (Tanner phase I);
• Obesity caused by secondary diseases or medications, including: elevated cortisol hormone (e.g. Cushing's syndrome), damage to the pituitary gland and hypothalamus, reduced dosage/discontinuation of weight-loss drugs or monogenic obesity, etc.;
• Have used any weight-loss drugs, hypoglycemic drugs, or drugs that may cause significant weight gain within 3 months prior to screening;
• Diagnosis with any type of diabetes;
• History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury