A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
NCT ID: NCT00392925
Last Updated: 2015-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
177 participants
INTERVENTIONAL
2006-10-31
2007-09-30
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
DOUBLE
Study Groups
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Placebo and Metreleptin
Placebo-pramlintide 600 microliters (µL) twice a day (BID) and metreleptin (recombinant-methionyl human leptin) 5 milligram (mg) BID, 20 weeks
metreleptin
subcutaneous injection, twice a day, 5mg
placebo-pramlintide 600 uL
twice a day
Pramlintide Acetate and Placebo
Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and placebo-metreleptin 1 mL BID, 20 weeks
pramlintide acetate 360 mcg
subcutaneous injection, twice a day, 360mcg
placebo-metreleptin 1 mL
twice a day
Pramlintide Acetate and Metreleptin
Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and metreleptin (recombinant-methionyl human leptin) 5 mg BID, 20 weeks
pramlintide acetate 360 mcg
subcutaneous injection, twice a day, 360mcg
metreleptin
subcutaneous injection, twice a day, 5mg
Lead-In Period
During the Lead-In Period before a participant was randomized to a study arm, the participant received 180 mcg pramlintide acetate twice a day (BID) for 2 weeks, followed by 360 mcg pramlintide acetate BID for 2 weeks (total of 4 weeks in the Lead-In Period).
pramlintide acetate 360 mcg
subcutaneous injection, twice a day, 360mcg
Pramlintide acetate 180 mcg
subcutaneous injection twice a day, 180 mcg
Interventions
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pramlintide acetate 360 mcg
subcutaneous injection, twice a day, 360mcg
metreleptin
subcutaneous injection, twice a day, 5mg
placebo-pramlintide 600 uL
twice a day
placebo-metreleptin 1 mL
twice a day
Pramlintide acetate 180 mcg
subcutaneous injection twice a day, 180 mcg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is a nonsmoker (has not smoked for at least 6 months prior to the study)
* Consumes a morning and evening meal each day
Exclusion Criteria
* Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program with the specific intent of losing weight (subjects who have been following an exercise regimen resulting in stable weight maintenance for at least 2 months prior to enrollment are eligible for study inclusion)
* Has been treated over the past 2 months, is currently treated, or is expected to require or undergo treatment with any of the following medications: \*antiobesity agents (prescription or over-the-counter), \*antipsychotic agents, \*antiepileptic agents, \*antidepressant agents, \*drugs that directly affect gastrointestinal motility
* Has received any investigational drug within 30 days or within a period corresponding to 5 half-lives of that drug, whichever is greater, prior to this study starting
* Has previously received treatment with recombinant leptin or pramlintide
18 Years
55 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
DeLand, Florida, 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
Butte, Montana, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Olympia, Washington, United States
Countries
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References
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Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2.
Other Identifiers
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DFA101
Identifier Type: -
Identifier Source: org_study_id
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