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This is a Phase 1, single-center, randomized, placebo-controlled, ascending dose study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM0504 following daily oral administrations in non-diabetic overweight or obese adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 20 mg BGM0504 administered orally |
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| Cohort 2 | Experimental | 40 mg BGM0504 administered orally |
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| Cohort 3 | Experimental | 60 mg BGM0504 administered orally |
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| Placebo | Placebo Comparator | Placebo administered orally |
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| Cohort 4 | Experimental | 80mg BGM0504 administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 | Drug | Administered orally |
| |
| BGM0504 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment adverse events | The relationship of each adverse event tothe investigational product was assessed by the investigator | 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic endpoint: Concentration of BGM0504 in plasma | 11 weeks | |
| Change in fasting weight at week 11 | 11 weeks |
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Inclusion Criteria:
Body mass index (BMI) meeting one of the following requirements:
Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening
Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MB ChB | Contact | 240-673-0900 | mohamed.al-ibrahim@pharmaron.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC, Inc | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Drug |
Administered orally |
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| BGM0504 | Drug | Administered orally |
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| Placebo | Drug | Administered orally |
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| BGM0504 | Drug | Administered orally |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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