A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
- Registration Number
- NCT00112021
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Is obese with a body mass index (BMI) >=30 kg/m^2 to <=50 kg/m^2, and has been obese for at least one year before screening.
- Usually consumes at least three major meals (morning, midday, and evening) each day.
Exclusion Criteria
- Is currently enrolled in a formal weight-loss program.
- Has had liposuction within 1 year before screening or is planning to have liposuction during the study.
- Has received any investigational drug within 3 months before screening.
- Has previously participated in a study using pramlintide.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pramlintide Acetate pramlintide acetate -
- Primary Outcome Measures
Name Time Method To examine the safety and tolerability of pramlintide in obese subjects Approximately 16 weeks To examine the effect of pramlintide on body weight in obese subjects Approximately 16 weeks
- Secondary Outcome Measures
Name Time Method To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters Approximately 16 weeks
Trial Locations
- Locations (1)
Research Site
🇺🇸Olympia, Washington, United States