This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
258
subcutaneous injection, three times a day, 120mcg
oral tablet, once a day, 10mg
oral tablet, once a day, 37.5mg
Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Chula Vista, California, United States
All treatment-emergent adverse events occurring during the 24-week treatment period
Time frame: 24 weeks
Absolute change in body weight from baseline to Week 12
Time frame: 12 weeks
Percent change in body weight from baseline to Week 12
Time frame: 12 weeks
Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
Time frame: 24 weeks
Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24
Time frame: 24 weeks
Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
Time frame: 24 weeks
Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
Time frame: 24 weeks
Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Time frame: 24 weeks
Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Time frame: 24 weeks
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subcutaneous injection, three times a day
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Miami, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Louisville, Kentucky, United States
Research Site
New York, New York, United States
...and 6 more locations