The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity
In this Phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous XW003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
664
Subcutaneous Injection
Subcutaneous Injection
Subcutaneous Injection
Peking University People's Hospital
Beijing, Beijing Municipality, China
Percent change in body weight from baseline
Time frame: Week 40
Proportion of subjects with weight loss ≥5% from baseline
Time frame: Week 40
Percent and absolute body weight change from baseline
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Change from baseline in BMI
height will be only measured at baseline
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
Change from baseline in waist and hip circumferences
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subcutaneous Injection with matched volume