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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

Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

Phase 3
Completed
Conditions
Infertility, Female
Interventions
Other: Caloric Restriction
Drug: Orlistat
Other: Moderate physical activity
First Posted Date
2015-05-04
Last Posted Date
2022-02-03
Lead Sponsor
Yale University
Target Recruit Count
379
Registration Number
NCT02432209
Locations
🇺🇸

Wayne State University, Southfield, Michigan, United States

🇺🇸

Augusta University, Augusta, Georgia, United States

🇺🇸

University of North Carolina, Chapel Hill, North Carolina, United States

and more 7 locations

Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea

Phase 2
Conditions
Obesity
Diabetes
Obstructive Sleep Apnea
Interventions
Other: Ketogenic diet
Other: Standardized diet
Drug: Orlistat
First Posted Date
2014-02-24
Last Posted Date
2018-08-17
Lead Sponsor
Mid-Atlantic Epilepsy and Sleep Center, LLC
Target Recruit Count
150
Registration Number
NCT02069197
Locations
🇺🇸

Mid-Atlantic Epilepsy and Sleep Center, LLC, Bethesda, Maryland, United States

Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment

Phase 4
Completed
Conditions
Type II Diabetes in Subjects BMI 27 to 32
Interventions
Procedure: Roux-en-Y Gastric Bypass (RYGB)
Drug: Incretin analogues
Drug: Xenical
Drug: SGLT2 inhibitors
Drug: DPP-4 Inhibitors
First Posted Date
2014-01-22
Last Posted Date
2022-06-23
Lead Sponsor
Khoo Teck Puat Hospital
Target Recruit Count
40
Registration Number
NCT02041234
Locations
🇸🇬

Khoo Teck Puat Hospital, Singapore, Singapore

Comparison of MAG and Fish Oil Efficacy

Not Applicable
Completed
Conditions
Obesity
Interventions
Dietary Supplement: Fish oil enriched with EPA
Dietary Supplement: MAG-EPA oil
Drug: Orlistat
First Posted Date
2013-02-22
Last Posted Date
2013-02-22
Lead Sponsor
Société des Produits Nestlé (SPN)
Target Recruit Count
46
Registration Number
NCT01797757
Locations
🇨🇭

CHUV Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud, Switzerland

The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects

Not Applicable
Withdrawn
Conditions
Overweight
Interventions
Drug: Placebo
Drug: Orlistat
First Posted Date
2012-11-01
Last Posted Date
2015-12-18
Lead Sponsor
Pennington Biomedical Research Center
Registration Number
NCT01719419
Locations
🇺🇸

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia

Phase 2
Terminated
Conditions
Type 1 Hyperlipoproteinemia
Interventions
First Posted Date
2012-08-29
Last Posted Date
2021-08-19
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
5
Registration Number
NCT01675154
Locations
🇺🇸

UT Southwestern Medical Center 5323 Harry Hines Blvd, Dallas, Texas, United States

🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding

Phase 4
Terminated
Conditions
Gastric Banding
Type 2 Diabetes
Interventions
First Posted Date
2012-05-14
Last Posted Date
2018-02-05
Lead Sponsor
East Carolina University
Target Recruit Count
1
Registration Number
NCT01597531
Locations
🇺🇸

Brody School of Medicine at East Carolina University, Greenville, North Carolina, United States

The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)

Phase 4
Conditions
Obesity
Polycystic Ovaries Syndrome
Interventions
Drug: Orlistat
Behavioral: Diet and physical exercise
Drug: Sibutramine
First Posted Date
2011-11-21
Last Posted Date
2011-11-21
Lead Sponsor
Aristotle University Of Thessaloniki
Target Recruit Count
200
Registration Number
NCT01475019
Locations
🇬🇷

Aristotle University of Thessaloniki Medical School, Thessaloniki, Greece

Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females

Not Applicable
Completed
Conditions
Overweight
Interventions
First Posted Date
2011-08-11
Last Posted Date
2011-08-11
Lead Sponsor
University of Campinas, Brazil
Target Recruit Count
17
Registration Number
NCT01414465
Locations
🇧🇷

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP), Campinas, Sao Paulo, Brazil

Survey on the Pharmacy Follow-up of Alli Purchasers

Completed
Conditions
Overweight
Interventions
First Posted Date
2011-07-04
Last Posted Date
2012-10-29
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
80
Registration Number
NCT01387243
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