Obesity
Conditions
Keywords
obesity, weight loss, Amylin, pramlintide, Symlin
Brief summary
This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the effect of pramlintide on body weight in obese subjects | Approximately 16 weeks |
| To examine the safety and tolerability of pramlintide in obese subjects | Approximately 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters | Approximately 16 weeks |
Countries
United States
Outcome results
None listed