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This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.
The purpose of this study is to obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.
This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APD356 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Changes in waist circumference, hip circumference and waist/hip ratio |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| Label | URL |
|---|---|
| obesity information | View source |
| N. American Association for the Study of Obesity web page | View source |
| sponsor company web page |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000855 | Anorexia |
| D015431 | Weight Loss |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| Pennington Biomedical Research Center home web page | View source |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D001836 | Body Weight Changes |