A Phase 3 Study to Evaluate the Efficacy of XW003 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.

Inclusion criteria

• Male or female, 18-75 years old, inclusive;
• BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities.
• Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
• Willing and able to maintain stable diet and exercise during the study period.

Exclusion criteria

• Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.
• History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period.
• Within 3 months before screening, history of using the following drugs or treatments:

• Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.
• Any hypoglycemic medication.
• Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.
• Any investigational drug, vaccine, or medical device.