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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

• 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:

1. Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females)

2. 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

Exclusion Criteria:

• Is expected to require or undergo treatment with any exclusionary medication.

• Is undesirable as a study participant as judged by the investigator