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The purpose of this study is to learn about the effects of BGE-102 on blood biomarkers including hsCRP, which is a lab value used to measure inflammation. BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo. This study will be checking safety and tolerability of BGE-102.
The purpose of this study is to assess the pharmacodynamics and safety of oral once a day (QD) dosing of BGE-102 at 3 dose levels compared to placebo over 12 weeks of treatment.
Study details include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: BGE-102 Dose A | Experimental | capsules dosed once daily in the morning |
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| Arm B: BGE-102 Dose B | Experimental | capsules dosed once daily in the morning |
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| Arm C: BGE-102 Dose C | Experimental | capsules dosed once daily in the morning |
|
| Arm D: Dose D | Placebo Comparator | capsules dosed once daily in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral BGE-102 | Drug | Capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in hsCRP (Dose A) | Percent change in hsCRP of the BGE-102 Dose A daily compared to Placebo | Week 12 |
| Percent change in hsCRP (Dose B) | Percent change in hsCRP of the BGE-102 Dose B daily compared to Placebo | Week 12 |
| Percent change in hsCRP (Dose C) | Percent change in hsCRP of the BGE-102 Dose C daily compared to Placebo | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse events (SAEs) | Up to Week 16 | |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to Week 16 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Central Recruiting | Contact | 866-521-2210 | infobge102-005@bioagelabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 108 | Recruiting | Chandler | Arizona | 85225 | United States |
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| Oral Placebo Matching BGE-102 | Drug | Capsules |
|
| Site 115 | Recruiting | Peoria | Arizona | 85381 | United States |
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| Site 110 | Recruiting | Tucson | Arizona | 85711 | United States |
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| Site 100 | Recruiting | Rogers | Arkansas | 72758 | United States |
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| Site 109 | Recruiting | Maitland | Florida | 32751 | United States |
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| Site 102 | Recruiting | Miami | Florida | 33172 | United States |
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| Site 104 | Recruiting | Port Orange | Florida | 32127 | United States |
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| Site 103 | Not yet recruiting | Lexington | Kentucky | 40509 | United States |
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| Site 106 | Recruiting | Rockville | Maryland | 20854 | United States |
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| Site 113 | Recruiting | Kansas City | Missouri | 64131 | United States |
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| Site 112 | Recruiting | Austin | Texas | 78759 | United States |
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| Site 101 | Recruiting | San Antonio | Texas | 78240 | United States |
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| Site 105 | Recruiting | San Juan | 00927 | Puerto Rico |
|
| 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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