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Last Updated: November 29, 2020

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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).
NCT00108524 A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss Completed VA Office of Research and Development N/A 2004-07-01 This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
NCT00152360 The Effect of Xenical on Weight and Risk Factors Completed University of British Columbia Phase 4 2005-06-01 The purpose of this study is to determine the effect of using the weight loss medication Xenical (generic name - orlistat) on weight loss and change in heart disease risk factors in patients of the Healthy Heart Program Lipid Clinic at St. Paul's Hospital over a three month period. Xenical works by blocking the body's absorption of dietary fat in the gut, allowing it to pass through to be excreted, therefore reducing the intake of fat and calories. This is a pilot study supported by Hoffmann-La Roche Limited which produces Xenical. The aim is to investigate whether weight loss will also result in reductions in heart disease risk factors that may allow for less of a need for medications controlling lipid levels, hypertension and plasma glucose.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Orlistat

Condition Name

Condition Name for Orlistat
Intervention Trials
Obesity 34
Overweight 8
Weight Loss 4
Diabetes Mellitus 3
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Condition MeSH

Condition MeSH for Orlistat
Intervention Trials
Obesity 19
Weight Loss 12
Overweight 12
Diabetes Mellitus 9
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Clinical Trial Locations for Orlistat

Trials by Country

Trials by Country for Orlistat
Location Trials
United States 52
United Kingdom 6
Brazil 4
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
Pennsylvania 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 3
Phase 2 16
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Clinical Trial Status

Clinical Trial Status for Orlistat
Clinical Trial Phase Trials
Completed 31
Recruiting 9
Not yet recruiting 5
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Clinical Trial Sponsors for Orlistat

Sponsor Name

Sponsor Name for Orlistat
Sponsor Trials
GlaxoSmithKline 5
Hoffmann-La Roche 4
Novo Nordisk A/S 3
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Sponsor Type

Sponsor Type for Orlistat
Sponsor Trials
Other 57
Industry 25
NIH 6
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