Reviewed by Michael Gill, B. Sc.
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What Are Xenical Clinical Trials?

Xenical is the brand name for a medication known as Orlistat, that is a medication for weight loss in obese patients. It works by preventing the absorption of fat in the stomach and intestines, and instead binds the fat to particles to be secreted.

Xenical clinical trials are important in order to determine the efficacy or success of this drug. Most Xenical clinical trials are run to determine the success of the drug over a long-term period, typically between one year or longer. These clinical trials indicate that with a change in diet, Xenical is effective in helping with weight loss.

Why Is Xenical Being Studied In Clinical Trials?

Xenical has been studied in clinical trials since the early 1990s. It was in 1999 when Xenical became approved by the Federal Drug Administration (FDA) to manage obesity alongside a diet that included reduced calories. Xenical was approved as a successful drug for weight loss, and also for assisting in the prevention of weight gain after the weight loss.

How Does Xenical Treatment Work?

The key mechanism for weight loss with Xenical lies in its ability to inhibit fats from breaking down in the stomach, entering the bloodstream and resulting in weight gain. Many clinical trials show that Xenical can prevent as much as 30 percent of fat from dietary intake from being absorbed in the body.

When fatty acids and enzymes are prevented from entering the bloodstream, they leave the system through normal excretion functions. Some of the side effects of Xenical then will be gastrointestinal discomfort, an effect most commonly reported during the initial use of Xenical. Once the patient becomes accustomed to Xenical, the symptoms will dissipate or disappear.

Because of its mechanism that prevents foreign cells from binding to human cells, Xenical’s generic medication called Orlistat has been found to be effective in the treatment of some tumor activity to prevent tumor growth and function as an antitumor agent in addition to being a medication for weight loss in obese patients.

What Are Some of the Breakthrough Clinical Trials Involving Xenical?

Xenical is a medication that has been studied since the 1990s and has been undergoing multiple breakthrough clinical trials prior to its FDA approval date in 1995. These are some of the most commonly cited Xenical clinical trials, although there are many.

1994: In this double-blind clinical trial for Xenical, the medication was examined in 103 men and 70 women who all received different doses of Xenical in order to determine its efficacy. Lipoprotein cholesterol levels reduced more dramatically at higher doses of Xenical than at lower, although some weight loss and cholesterol control was indicated in lower doses. Adverse side effects including stomach or gastrointestinal discomfort were noted.

1997: In this one-year clinical trial for Xenical, researchers examined the use of Xenical across multiple locations to determine if it was tolerable at the 120 mg dose. The clinical trial determined it could result in more weight loss than weight loss on diet alone.

Who Are The Key Opinion Leaders On Xenical Clinical Trial Research?

Pengyu Yang, Plexium

Pengyu Yang is a Director at Plexium with a PhD in chemistry who has conducted or participated in multiple research studies on Orlistat for its effects on weight loss. Pengyu Yang has also been in integral in the publication of numerous studies on the anti-tumor action of Orlistat.

Yu-Jin Kwon, Yonsei University College of Medicine

Yu-Jin Kwon is an associate professor at the University College of Medicine in the Department of Family Medicine for Yongin Severance Hospital and has been studying Orlistat for his entire career. His work with Xenical in clinical trials began with his PhD dissertation on the effects of Orlistat versus phentermine on weight loss.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References1 Patni N, Quittner C, Garg A. Orlistat Therapy for Children With Type 1 Hyperlipoproteinemia: A Randomized Clinical Trial. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2403-2407. doi: 10.1210/jc.2018-00369.