Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
NCT00444561 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184
Last updated 2015-06-11
Summary
This exploratory study is designed to evaluate various pharmacodynamic effects of subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and postmenopausal female (not on hormone replacement therapy) subjects. The study will also assess the safety and tolerability of pramlintide administered by SC infusion or injection.
Conditions
Interventions
- DRUG
-
pramlintide acetate
Clear, colorless, sterile solution for SC administration
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Lisa Porter, MD · Amylin Pharmaceuticals, LLC.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-08-31
- Primary Completion
- 2005-05-31
- Completion
- 2005-05-31
Countries
- United States
Study Locations
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