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Orlistat

Generic Name
Orlistat
Brand Names
Alli, Xenical, Alli (previously Orlistat GSK)
Drug Type
Small Molecule
Chemical Formula
C29H53NO5
CAS Number
96829-58-2
Unique Ingredient Identifier
95M8R751W8
Background

The global prevalence of obesity is increasing rapidly. Obesity-related complications lead to significant personal and economic burden by reducing quality of life and increasing the cost of healthcare. In some individuals, diet and exercise are insufficient to maintain weight loss, and pharmacological or surgical intervention is required.

Orlistat is a lipase inhibitor used in the treatment of obesity that works by inhibiting fat-metabolizing enzymes. It was approved by the FDA for use in combination with a reduced-calorie diet in 1999. This drug is a generally well-tolerated and effective weight-loss aid and is now available in both over-the-counter and prescription preparations, depending on the dosage quantity.

Indication

Orlistat is indicated for obesity management including weight loss and weight maintenance when used in combination with calorie reduction in overweight and obese adults; this indication applies to both the prescription formulation of 120 mg and the over-the-counter formulation of 60 mg. Orlistat in the 120 mg prescription formulation is also indicated to reduce the risk of weight regain following weight loss.

Associated Conditions
Weight Gain
Associated Therapies
Weight Reduction

Efficacy and Safety of ATL-962 in Obese Diabetics

Phase 2
Completed
Conditions
Non-Insulin-Dependent Diabetes Mellitus
Obesity
First Posted Date
2005-09-12
Last Posted Date
2006-08-29
Lead Sponsor
Alizyme
Target Recruit Count
600
Registration Number
NCT00156897
Locations
🇫🇮

Obesity Research Unit, Helsinki, Finland

🇫🇮

Oy Foodfiles Limited, Kuopio, Finland

🇫🇮

Oulun Diakonissalaitos, Oulu, Finland

and more 32 locations

The Effect of Xenical on Weight and Risk Factors

Phase 4
Completed
Conditions
Obesity
Heart Diseases
Interventions
First Posted Date
2005-09-09
Last Posted Date
2013-04-01
Lead Sponsor
University of British Columbia
Target Recruit Count
25
Registration Number
NCT00152360
Locations
🇨🇦

Healthy Heart Program/Lipid Clinic, St. Paul's Hospital, Vancouver, British Columbia, Canada

A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

Not Applicable
Completed
Conditions
Obesity
Diabetes Mellitus
Interventions
Behavioral: Low carbohydrate ketogenic diet
Drug: Orlistat
Behavioral: Low-fat diet
First Posted Date
2005-04-18
Last Posted Date
2014-04-17
Lead Sponsor
US Department of Veterans Affairs
Target Recruit Count
146
Registration Number
NCT00108524
Locations
🇺🇸

Durham VA Medical Center HSR&D COE, Durham, North Carolina, United States

Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases

Phase 2
Completed
Conditions
Diabetes Mellitus
Hypertension
Metabolic Disease
Obesity
Sleep Apnea Syndrome
Interventions
Drug: Placebo
Drug: Orlistat
First Posted Date
1999-11-04
Last Posted Date
2012-12-18
Lead Sponsor
Jack Yanovski
Target Recruit Count
200
Registration Number
NCT00001723
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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