Obesity, Primary Insulin Hypersecretion
Conditions
Keywords
Primary Insulin Hypersecretion, PIH, Obesity
Brief summary
This study is in patients with at least moderate obesity (Body Mass Index \[BMI\] \> 30 kg/m2 or approximately 30 or more pounds overweight) and who also produce too much insulin (insulin stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to help with weight loss in people who find it hard to lose weight on their own because they produce too much insulin. The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that safely helps overweight people lose weight. The study will also compare weight loss in obese patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.
Interventions
Sponsors
Novartis
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
You may qualify for this study if you: * are between the ages of 18-70 (male or female) * are at least moderately obese (BMI \> 30 kg/m2 or approximately 30 or more pounds overweight) * and pass an oral glucose tolerance test (a 3 hour test to determine if your body produces too much insulin)
Exclusion criteria
You are not qualified for this study if you: * have diabetes * have been able to lose weight with diet and exercise alone * have previously received Sandostatin LAR® Depot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change at baseline compared to 6 months in body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare changes from baseline and at 6 months in body mass index (BMI), percentage of total body fat percentage of abdominal fat, leptin, and waist-to-hip ratio | — |
Countries
United States
Outcome results
None listed