Overweight or Obesity
Conditions
Brief summary
To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
Interventions
DRUGBGM0504
Administered SC
DRUGPlacebo
Administered SC
Sponsors
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in body weight | Week 0 to Week 24 | Percentage change from baseline in body weight after 24 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects with weight loss of ≥5% | Week 0 to Week 24 | Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment |
| Change from baseline in waist circumference | Week 0 to Week 24 | Change from baseline in waist circumference after 24 weeks of treatment |
| Change from baseline in BMI | Week 0 to Week 24 | Change from baseline in BMI after 24 weeks of treatment |
| Change from baseline in fasting plasma glucose (FPG) | Week 0 to Week 24 | Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment |
Countries
China
Outcome results
None listed