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Last Updated: November 27, 2022

CLINICAL TRIALS PROFILE FOR ORLISTAT


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505(b)(2) Clinical Trials for Orlistat

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT01550926 ↗ A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms Completed GlaxoSmithKline Phase 1 2009-02-01 The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Orlistat

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001723 ↗ Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1998-05-01 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).
NCT00001723 ↗ Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Roche Pharma AG Phase 2 1998-05-01 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).
NCT00001723 ↗ Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Completed Jack Yanovski Phase 2 1998-05-01 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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Orlistat

Condition Name

Condition Name for Orlistat
Intervention Trials
Obesity 33
Overweight 8
Weight Loss 3
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Condition MeSH

Condition MeSH for Orlistat
Intervention Trials
Obesity 23
Overweight 13
Weight Loss 11
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Clinical Trial Locations for Orlistat

Trials by Country

Trials by Country for Orlistat
Location Trials
United States 53
United Kingdom 6
Brazil 6
Sweden 4
Netherlands 3
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Trials by US State

Trials by US State for Orlistat
Location Trials
Texas 6
North Carolina 5
New York 4
California 4
Ohio 3
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Clinical Trial Progress for Orlistat

Clinical Trial Phase

Clinical Trial Phase for Orlistat
Clinical Trial Phase Trials
Phase 4 17
Phase 3 6
Phase 2 16
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Clinical Trial Status

Clinical Trial Status for Orlistat
Clinical Trial Phase Trials
Completed 37
Unknown status 5
Active, not recruiting 5
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Clinical Trial Sponsors for Orlistat

Sponsor Name

Sponsor Name for Orlistat
Sponsor Trials
Hoffmann-La Roche 5
GlaxoSmithKline 5
University of Minnesota 3
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Sponsor Type

Sponsor Type for Orlistat
Sponsor Trials
Other 61
Industry 28
NIH 6
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