DRUG
pramlintide acetate
subcutaneous injection, three times a day, 120mcg
Status
Completed
Phase
Phase 2
Enrollment
258
Locations
16
Results
Not posted
Publications
0
Study 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
DRUG
subcutaneous injection, three times a day, 120mcg
DRUG
oral tablet, once a day, 10mg
DRUG
oral tablet, once a day, 37.5mg
DRUG
subcutaneous injection, three times a day
Timeline
First posted
Nov 22, 2006
Study start
Nov 2006
Primary completion
Aug 2007
Study completion
Aug 2007
Results posted
Not reported
Registry updated
Mar 6, 2015
Outcomes
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
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Chula Vista, California, United States
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
Research Site
Raleigh, North Carolina, United States
Research Site
Statesville, North Carolina, United States
Research Site
Eugene, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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