Obesity
Conditions
Brief summary
To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
Interventions
DRUGBGM0504
Administered SC
DRUGTirzepatide
Administered SC
Sponsors
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ● Able and willing to provide a written informed consent. * Male or female subjects, 18-65 years of age at the time of signing informed consent. * At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2; * Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.
Exclusion criteria
* ●History of chronic or acute pancreatitis. * History of severe drug allergy or specific allergic disease or severe allergies. * Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2). * History of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\]. * Suspected or confirmed history of alcohol or drug abuse; * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP). * Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial. * Pregnant or lactating woman. * Any disorder, unwillingness, or inability not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight | Week 0, Week 26 | Change from baseline in body weight after 26 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BMI | Week 18, Week 26 | Change from baseline in BMI after 26 weeks of treatment |
| Change From Baseline in Waist Circumference | Week 18, Week 26 | Change from baseline in waist circumference after 26 weeks of treatment |
| Change from Baseline in Systolic Blood Pressure (SBP) | Week 18, Week 26 | Change from Baseline in SBP after 26 weeks of treatment |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Week 18, Week 26 | Change from Baseline in DBP after 26 weeks of treatment |
| Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) | Week 0, Week 26 | Change from Baseline in IWQOL-Lite-CT after 26 weeks of treatment |
Countries
China
Contacts
Primary ContactLinong Ji
Outcome results
None listed