Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
NCT ID: NCT00673387
Last Updated: 2015-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
636 participants
INTERVENTIONAL
2008-04-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Placebo-P + Placebo-M
Placebo matched to pramlintide BID plus placebo matched to metreleptin BID
placebo-P
subcutaneous injection, twice a day
placebo-M
subcutaneous injection, twice a day
Pramlintide 360 mcg + Placebo-M
360 mcg pramlintide given twice per day (BID) plus Placebo matched to Metreleptin given BID
pramlintide acetate
subcutaneous injection, twice a day
placebo-M
subcutaneous injection, twice a day
Placebo-P + Metreleptin 5.0 mg
Placebo matched to pramlintide BID plus metreleptin 5.0 mg BID
metreleptin
subcutaneous injection, twice a day
placebo-P
subcutaneous injection, twice a day
Pramlintide 180 mcg + Metreleptin 2.5 mg
Pramlintide 180 mcg BID plus Metreleptin 2.5 mg BID
pramlintide acetate
subcutaneous injection, twice a day
metreleptin
subcutaneous injection, twice a day
Pramlintide 180 mcg + Metreleptin 5.0 mg
Pramlintide 180 mcg BID plus Metreleptin 5.0 mg BID
pramlintide acetate
subcutaneous injection, twice a day
metreleptin
subcutaneous injection, twice a day
Pramlintide 360 mcg + Metreleptin 1.25 mg
Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID
pramlintide acetate
subcutaneous injection, twice a day
metreleptin
subcutaneous injection, twice a day
Pramlintide 360 mcg + Metreleptin 2.5 mg
Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID
pramlintide acetate
subcutaneous injection, twice a day
metreleptin
subcutaneous injection, twice a day
Pramlintide 360 mcg + Metreleptin 5.0 mg
Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID
pramlintide acetate
subcutaneous injection, twice a day
metreleptin
subcutaneous injection, twice a day
Interventions
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pramlintide acetate
subcutaneous injection, twice a day
metreleptin
subcutaneous injection, twice a day
placebo-P
subcutaneous injection, twice a day
placebo-M
subcutaneous injection, twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is obese (Body Mass Index \[BMI\]\>=30kg/m\^2 and \<=35kg/m\^2); or overweight (BMI\>=27kg/m\^2 and \<30kg/m\^2.
* Has stable body weight, i.e., not varying by \>3% within 3 months prior to study.
* Has not been treated over the past 3 months or is currently treated with any of the following medications: Oral contraceptives (female subjects); Hormone replacement therapy (female subjects); Metformin for the treatment of polycystic ovary syndrome (female subjects); Antihypertensive agents; Lipid-lowering agents; Thyroid replacement therapy; selective serotonin reuptake inhibitors (SSRIs).
* Is comfortable with having repeated telephone contacts with a lifestyle counselor during the study.
* Is a nonsmoker (has not smoked for at least 6 months prior to the study).
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 \*antiobesity agents (prescription or over-the-counter), \*antipsychotic agents, \*antiepileptic agents, \*antidepressant agents, \*drugs that directly affect gastrointestinal motility, \*antidiabetic medications.
* Has previously received treatment with metreleptin or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®).
* 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 had a major surgery or a blood transfusion, or has donated blood over the past 2 months or is planning to donate blood during the study.
* Has had liposuction, abdominoplasty, or similar procedure over the past year or is planning to have such a procedure 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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Vice President Research and Development, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Chandler, Arizona, United States
Research Site
Santa Rosa, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Denver, Colorado, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Pembrook Pines, Florida, United States
Research Site
Plantation, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Overland Park, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Auburn, Maine, United States
Research Site
Boston, Massachusetts, United States
Research Site
Edina, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
New York, New York, United States
Research Site
Statesville, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Eugene, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Anderson, South Carolina, United States
Research Site
Greer, South Carolina, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Norfolk, Virginia, United States
Research Site
Belingham, Washington, 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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DFA102
Identifier Type: -
Identifier Source: org_study_id
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