A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects (NCT06973681) | Clinical Trial Compass
CompletedPhase 2
A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects
China120 participantsStarted 2023-10-13
Plain-language summary
To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
Who can participate
Age range18 Years – 60 Years
SexALL
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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.