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This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramlintide acetate | Drug | Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. | open ended | |
| Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects. | open ended |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters. | open ended |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Porter, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chula Vista | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18753666 | Derived | Smith SR, Aronne LJ, Burns CM, Kesty NC, Halseth AE, Weyer C. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. 2008 Sep;31(9):1816-23. doi: 10.2337/dc08-0029. Epub 2008 Jun 20. |
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| placebo | Drug | subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate |
|
| San Diego |
| California |
| United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Augusta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Overland Park | Kansas | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | Edina | Minnesota | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Butte | Montana | United States |
| Research Site | New York | New York | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Austin | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Olympia | Washington | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| 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 |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| C105254 | pramlintide |
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