The Third Xiangya Hospital of Central South University
Changsha, China
NCT Number: NCT06973681
To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Changsha, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Administered SC
Administered SC
Time frame: Week 0 to Week 24
Percentage change from baseline in body weight after 24 weeks of treatment.
Time frame: Week 0 to Week 24
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
Time frame: Week 0 to Week 24
Change from baseline in waist circumference after 24 weeks of treatment
Time frame: Week 0 to Week 24
Change from baseline in BMI after 24 weeks of treatment
Time frame: Week 0 to Week 24
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
BrightGene Bio-Medical Technology Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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