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To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGM0504 | Experimental | Participants will receive BGM0504 subcutaneously(SC). |
|
| Tirzepatide | Active Comparator | Paritcipants will receive tirzepatide SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 | Drug | Administered SC |
| |
| Tirzepatide |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Change from baseline in body weight after 26 weeks of treatment | Week 0, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BMI | Change from baseline in BMI after 26 weeks of treatment | Week 18, Week 26 |
| Change From Baseline in Waist Circumference | Change from baseline in waist circumference after 26 weeks of treatment |
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Inclusion Criteria:
● Able and willing to provide a written informed consent.
Exclusion Criteria:
●History of chronic or acute pancreatitis.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linong Ji | Contact | +8613910978815 | jiln@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Drug |
Administered SC |
|
| Week 18, Week 26 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Change from Baseline in SBP after 26 weeks of treatment | Week 18, Week 26 |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Change from Baseline in DBP after 26 weeks of treatment | Week 18, Week 26 |
| Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) | Change from Baseline in IWQOL-Lite-CT after 26 weeks of treatment | Week 0, Week 26 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |