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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Pramlintide and Metreleptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819234

DFA102E

Details and patient eligibility

About

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.

Enrollment: 274 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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274 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Description:

Pramlintide and 1.25mg Metreleptin

Treatment:

Drug: Pramlintide and Metreleptin

3

Experimental group

Description:

Pramlintide and 2.5mg Metreleptin

Treatment:

Drug: Pramlintide and Metreleptin

4

Experimental group

Description:

Pramlintide and 5.0mg Metreleptin

Treatment:

Drug: Pramlintide and Metreleptin