Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication. The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.

Key facts

Study ID

NCT00819234

Run by

AstraZeneca

People needed

274

Starts

2008-11-01

Expected to finish

2009-11-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations
• Male, or female and meets all the following criteria:
• Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)
• If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
• Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements

You may not qualify if…

• Is expected to require or undergo treatment with any exclusionary medication.
• Is undesirable as a study participant as judged by the investigator

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Phoenix, Arkansas, 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 — Plantation, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Springfield, Illinois, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Baton Rouge, Louisiana, 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 — 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

Full record on ClinicalTrials.gov

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