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This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGM1812 (Part A) | Experimental | Single ascending doses of BGM1812 administered subcutaneously (SC). |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC. |
|
| BGM1812 (Part B) | Experimental | Multiple ascending doses of BGM1812 administered SC. |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM1812 | Drug | Administered SC. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment adverse events | The relationship of each adverse event to the investigational product was assessed by the investigator | Predose up to 6 weeks (Part A) & 9 weeks (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of BGM1812 | PK: AUC of BGM1812 | Predose through week 6 (Part A) & week 9 (Part B) |
| PK: Maximum Observed Concentration (Cmax) of BGM1812 |
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Inclusion Criteria:
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.
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
Exclusion Criteria:
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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 SC. |
|
| BGM1812 | Drug | Administered SC. |
|
| Placebo | Drug | Administered SC. |
|
PK: Cmax of BGM1812
| Predose through week 6 (Part A) & week 9 (Part B) |
| Pharmacodynamics (PD): Change from baseline in fasting body weight | Pharmacodynamics (PD): Change from baseline in fasting body weight | Predose through week 6 (Part A) & week 9 (Part B) |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| 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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