Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the influence of BGM0504 injection on gastric emptying and Pharmacokinetics of metformin and warfarin in overweight or obese participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol + Metformin + Warfarin +BGM0504 | Experimental | Participants receive Paracetamol on Day1 and Day70, Metformin on Day4 and Day73, Warfarin on Day7 and Day77. Participants receive maintenance dose 10 mg (from D42 to Day 77) with dose escalation starting from 2.5 mg(on Day 14 and Day 21), 5 mg(on Day 28 and Day 35) and then 10 mg BGM0504 administered subcutaneously (SC) once weekly (QW). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | oral, postprandial |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Paracetamol | From Day1 to Day72 |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Paracetamol | Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) of Paracetamol | From Day1 to Day72 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Metformin | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Metformin | From Day4 to Day76 |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin | From Day4 to Day76 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin | From Day7 to Day84 |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin | From Day7 to Day84 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504 | Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504 | From Day14 to Day69 |
| Time to Maximum Concentration (Tmax) of Metformin and Warfarin |
Not provided
Inclusion Criteria: √ Have a body mass index (BMI) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (<) 28 kg/m².
√ Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.
Exclusion Criteria: √ History of chronic or acute pancreatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine) | Kunming | Yunnan | 650100 | China |
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D008687 | Metformin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metformin Hydrochloride |
| Drug |
Oral , Fasting |
|
| Warfarin | Drug | Oral , Fasting |
|
| BGM0504 | Drug | Administered SC |
|
Time to Maximum Concentration (Tmax) of Metformin and Warfarin |
| From Day1 to Day84 |
| Terminal Half-life (t1/2) of Paracetamol | Terminal Half-life (t1/2) of Paracetamol | From Day1 to Day72 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |