Overweight, Obesity
Conditions
Keywords
overweight, obesity, pramlintide, Symlin, sibutramine, Meridia, phentermine, Amylin
Brief summary
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.
Interventions
subcutaneous injection, three times a day, 120mcg
DRUGsibutramine
oral tablet, once a day, 10mg
DRUGphentermine
oral tablet, once a day, 37.5mg
DRUGplacebo
subcutaneous injection, three times a day
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Is obese with a Body Mass Index (BMI) \>=30 kg/m\^2 to \<=50 kg/m\^2 or overweight with a BMI \>=27 kg/m\^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions) * Has been obese or overweight for at least one year prior to study start * Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: \*hormone replacement therapy; \*oral contraceptives; \*lipid-lowering agents; \*thyroid replacement therapy; \*metformin
Exclusion criteria
* Is currently enrolled in or is planning to enroll in a formal weight-loss program * Is unwilling or unable to participate in a lifestyle intervention program as part of the study * Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: \*prescription or over the counter antiobesity agents (within the 6 months prior to study start); \*psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); \*steroids that are known to result in high systemic absorption; \*calcitonin; \*ketoconazole; \*antidiabetic medications * Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study * Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start * Has previously used pramlintide either by prescription or as part of a clinical study * Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start * Has donated blood within 2 months before study start, or is planning to donate blood during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All treatment-emergent adverse events occurring during the 24-week treatment period | 24 weeks |
| Absolute change in body weight from baseline to Week 12 | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24 | 24 weeks |
| Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24 | 24 weeks |
| Percent change in body weight from baseline to Week 12 | 12 weeks |
| Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24 | 24 weeks |
| Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24 | 24 weeks |
| Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24 | 24 weeks |
| Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24 | 24 weeks |
Countries
United States
Outcome results
None listed