Approval Probability
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orlistat · 2 trials · 5 indications
Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | OTHER | - |
| Placebo | PLACEBO_COMPARATOR | Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program |
| Orlistat | EXPERIMENTAL | Orlistat 120 mg TID for 6 months plus a behavioral weight loss program |
| Name | Type | Description |
|---|---|---|
| Diet and Exercise | BEHAVIORAL | mildly hypocaloric diet and physical exercise |
| orlistat [Xenical] | DRUG | 120mg po tid |
| Orlistat | DRUG | Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months. |
| Placebo | DRUG | Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months. |
Inclusion Criteria: * adolescent patients, 12-14 years of age * overweight or obese Exclusion Criteria: * age \<12 or \>14 years * BMI in normal range
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Orlistat is used for obesity and diabetes mellitus. It is being studied in children and adolescents with obesity-related diseases, including diabetes, hypertension, metabolic disease, and sleep apnea syndrome. The drug is also being evaluated in overweight and obese adolescents.
Orlistat is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in pediatric and adolescent populations with obesity-related conditions.
Orlistat is in Phase 2 clinical development. One Phase 2 trial has been completed, and a Phase 3 trial has also been completed. The drug is investigational and not yet approved for the studied indications.
Orlistat has completed two clinical trials. NCT00001723 is a Phase 2 study of Xenical in children and adolescents with obesity-related diseases, enrolling 200 participants in the United States. NCT00940628 is a Phase 3 study in overweight and obese adolescents in Russia, enrolling 60 participants.
Yes, Orlistat is the same as Xenical. The clinical trials NCT00001723 and NCT00940628 both use the name Xenical to refer to the drug orlistat. This alternative name is used in the study titles for the drug being investigated.
Orlistat is a small molecule that works by inhibiting gastrointestinal lipases, enzymes that break down dietary fat. By blocking these enzymes, orlistat reduces fat absorption in the gut, which helps with weight management in obese individuals and those with related metabolic conditions.