Status:
COMPLETED
A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects
Lead Sponsor:
BrightGene Bio-Medical Technology Co., Ltd.
Conditions:
Overweight or Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06973681
Start Date
October 13 2023
End Date
September 13 2024
Last Update
May 15 2025
Active Locations (1)
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1
The Third Xiangya Hospital of Central South University
Changsha, China