A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects
NCT ID: NCT00402077
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
258 participants
INTERVENTIONAL
2006-11-30
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
pramlintide acetate
subcutaneous injection, three times a day, 120mcg
2
pramlintide acetate
subcutaneous injection, three times a day, 120mcg
sibutramine
oral tablet, once a day, 10mg
3
pramlintide acetate
subcutaneous injection, three times a day, 120mcg
phentermine
oral tablet, once a day, 37.5mg
4
placebo
subcutaneous injection, three times a day
Interventions
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pramlintide acetate
subcutaneous injection, three times a day, 120mcg
sibutramine
oral tablet, once a day, 10mg
phentermine
oral tablet, once a day, 37.5mg
placebo
subcutaneous injection, three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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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
Countries
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Other Identifiers
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AFA203
Identifier Type: -
Identifier Source: org_study_id
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