A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Safety, Tolerability, PK/PD Profile, and Efficacy of Multiple Doses of BGM0504 Injection in Overweight or Obese Subjects Without Diabetes

To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.

Inclusion Criteria:

• 1. BMI ≥ 28.0 kg/m2 or 24.0 ≤ BMI < 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit; 2.Controlled by diet and exercise alone for at least 12 weeks prior to Screening with <5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial.

Exclusion Criteria:1.Those who have used weight loss drugs within 12 weeks before screening; 2. Previous diagnosis of type 1 or type 2 diabetes mellitus; 3. History of acute or chronic pancreatitis, or pancreatic injury; 4. History of thyroid C-cell carcinoma, MEN (multiple endocrine adenomatosis) 2A or 2B, or relevant family history; 5. Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening; 6. Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose atscreening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy; 7. At Screening, abdominal ultrasound indicated calculus gallbladder and polyps, or presence of clinical symptoms of gallbladder disease at Screening; 8. Pregnant or breastfeeding women.