Pediatric Hypothalamic Obesity
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 60
- Locations
- 15
- Primary Endpoint
- Change from baseline in BMI
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ that secretes hormones). The purpose of this trial is to see how an investigational treatment controls the hormone insulin by lowering the level of insulin in the body resulting in a weight loss in children who are at least 6 years of age but less than 18 years of age. Some children in this trial will receive placebo.
To qualify for this study, you and your child's doctor must feel that your child's weight is inadequately controlled within a year from the time of injury to the hypothalamus or tumor of the hypothalamus. This study will help to determine if an investigational treatment is of benefit in controlling a child's weight.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline in BMI
Secondary Outcomes
- Change from baseline in weight, leptin, insulin AUC, C-peptide AUC, amylin AUC, glucose AUC, dietary intake, physical activity, waist-to-hip ratio, visceral and subcutaneous abdominal fat