Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
Obesity is a condition affecting one-third off the U.S. population and is a major risk actor
for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the
blood), hypertension (high blood pressure), and other disorders of the heart and lungs.
Individuals with the onset of obesity during childhood or adolescence are at an increased
risk of obesity-related, diseases, both during adolescence and later in adult life.
African American girls and women are at an increased risk for obesity, and have substantial
rates of obesity-related diseases and causes of death. Further, many African American adult
women fail to respond to many of the therapeutic approaches used to treat obesity. At present
there are no medical therapies proven effective for the correction of severe obesity in
children or adolescents.
One medication that may have a favorable risk-benefit ratio in pediatric populations is
Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in
the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten
in the diet. Xenical appears to be effective for reducing weight and obesity-associated
diseases in obese adults.
Researchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17
year old severely obese African American and Caucasian children and adolescents who have one
or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic
steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).
Phase:
Phase 2
Details
Lead Sponsor:
Jack Yanovski
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Roche Pharma AG