A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

A Phase 3, Multi-center, Randomized, Double-Blind and Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Adults With Overweight or Obesity (SLIMMER)

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.

Inclusion Criteria:

1. Male or female, 18-75 years old, inclusive;
2. 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.
3. Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
4. Willing and able to maintain stable diet and exercise during the study period.

Exclusion Criteria:

1. Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.

2. History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period.

3. Within 3 months before screening, history of using the following drugs or treatments:

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