CLINICAL TRIALS PROFILE FOR ORLISTAT

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.

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).

Clinical Trial Conditions for Orlistat

Condition Name

Condition Name for Orlistat
Intervention	Trials
Obesity	34
Overweight	8
Weight Loss	3

Condition MeSH

Condition MeSH for Orlistat
Intervention	Trials
Obesity	24
Overweight	14
Weight Loss	11

Clinical Trial Locations for Orlistat

Trials by Country

Trials by Country for Orlistat
Location	Trials
United States	53
Brazil	6
United Kingdom	6
Sweden	5
China	4

Trials by US State

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

Clinical Trial Progress for Orlistat

Clinical Trial Phase

Clinical Trial Phase for Orlistat
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	6
Phase 2	17

Clinical Trial Status

Clinical Trial Status for Orlistat
Clinical Trial Phase	Trials
Completed	37
Active, not recruiting	5
Terminated	5

Clinical Trial Sponsors for Orlistat

Sponsor Name

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

Sponsor Type

Sponsor Type for Orlistat
Sponsor	Trials
Other	63
Industry	31
NIH	6

Orlistat: Clinical Trials, Market Analysis, and Projections

Introduction to Orlistat

Orlistat, a gastrointestinal lipase inhibitor, is a widely used medication for weight loss and the prevention of type 2 diabetes in obese individuals. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials: Efficacy and Safety

XENDOS Study

One of the most significant clinical trials involving orlistat is the XENDOS (XENical in the prevention of Diabetes in Obese Subjects) study. This 4-year, double-blind, prospective study randomized 3,305 obese patients to either orlistat 120 mg or a placebo, three times daily, in addition to lifestyle changes. The primary endpoints were the time to onset of type 2 diabetes and changes in body weight.

• The study found that orlistat significantly reduced the progression to type 2 diabetes, with a cumulative incidence of 6.2% compared to 9.0% for the placebo group, representing a 37.3% risk reduction[1].
• Orlistat also resulted in greater weight loss, with a mean weight loss of 5.8 kg over 4 years compared to 3.0 kg for the placebo group[1].

Other Clinical Trials

Other trials have also highlighted the efficacy of orlistat in weight management and risk factor reduction. A 2-year randomized controlled trial showed that orlistat treatment led to significant weight loss and improvements in risk factors for cardiovascular disease. The trial also noted that the completion rate and reasons for withdrawal were not significantly different between the orlistat and placebo groups[4].

Market Analysis

Current Market Size and Growth

The global orlistat market is substantial and growing. As of 2024, the market size is estimated to be USD 3.15 billion, with a projected compound annual growth rate (CAGR) of 6.10% from 2024 to 2031[2].

Regional Market Dynamics

• North America: This region holds the largest share of the global orlistat market, with over 40% of the global revenue. The market here is driven by high obesity rates, a diverse consumer base, and effective distribution channels[2].
• Asia Pacific: This region exhibits dynamic growth, driven by rising obesity rates, urbanization, and shifting consumer preferences towards healthier lifestyles. The market size here is expected to grow at a CAGR of 8.1% from 2024 to 2031[2].
• Latin America: The market in Latin America is growing at a CAGR of 5.5% from 2024 to 2031, driven by increasing obesity rates and a growing emphasis on preventive healthcare. However, challenges such as affordability and regulatory constraints need to be addressed[2].
• Middle East and Africa: This region shows significant potential for expansion, driven by rising obesity rates and increasing awareness of health issues. The market is expected to grow at a CAGR of 5.8% from 2024 to 2031[2].

Market Projections

Future Growth

The orlistat market is expected to continue its strong growth trajectory. Here are some key projections:

• Global Market Size: The market is anticipated to reach USD 3.91 billion by 2028, growing at a CAGR of 6.5% from 2023 to 2028[5].
• Drivers of Growth: Rising healthcare expenditures on obesity treatments, sedentary lifestyles, poor eating habits, government initiatives promoting weight loss, an aging population, and the shift from prescriptions to over-the-counter options are expected to drive this growth[5].

Emerging Trends

Several trends are expected to shape the orlistat market in the coming years:

• AI-Powered Diet Plans: The integration of artificial intelligence in diet planning and weight management is likely to enhance the efficacy of orlistat treatment.
• Telehealth Services: Increased use of telehealth services will improve access to weight loss programs and medication adherence.
• Automated Devices: Devices for medication reminders and adherence tracking will become more prevalent.
• Virtual Reality Workouts: Virtual reality workouts and digital therapeutics will offer new avenues for weight loss and health management[5].

Anti-Obesity Medication Market Context

Orlistat is part of a broader anti-obesity medication market that is experiencing significant growth. The global anti-obesity medication market was estimated at USD 6.62 billion in 2023 and is projected to grow at a CAGR of 31.66% from 2024 to 2030. This growth is driven by investments in R&D, leading to the development of new and innovative weight loss medications[3].

Key Takeaways

• Clinical Efficacy: Orlistat has been shown to significantly reduce the risk of type 2 diabetes and promote weight loss in obese individuals.
• Market Growth: The global orlistat market is expected to grow at a CAGR of 6.10% from 2024 to 2031, driven by rising obesity rates and increasing healthcare expenditures.
• Regional Dynamics: North America, Asia Pacific, Latin America, and the Middle East and Africa are key regions driving the market growth.
• Emerging Trends: AI-powered diet plans, telehealth services, automated devices, and virtual reality workouts are expected to shape the future of the orlistat market.

FAQs

Q: What is the primary mechanism of action of orlistat?

A: Orlistat works by inhibiting gastrointestinal lipases, which reduces the absorption of dietary fats.

Q: What were the key findings of the XENDOS study?

A: The XENDOS study found that orlistat significantly reduced the risk of developing type 2 diabetes by 37.3% and resulted in greater weight loss compared to the placebo group.

Q: What is the projected growth rate of the global orlistat market from 2024 to 2031?

A: The global orlistat market is expected to grow at a CAGR of 6.10% from 2024 to 2031.

Q: Which region holds the largest share of the global orlistat market?

A: North America holds the largest share of the global orlistat market, driven by high obesity rates and effective distribution channels.

Q: What are some emerging trends in the orlistat market?

A: Emerging trends include AI-powered diet plans, telehealth services, automated devices for medication adherence, and virtual reality workouts.

Sources

1. XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) Study - Diabetes Care, January 2004.
2. Orlistat Market Report - Cognitive Market Research, April 2024.
3. Anti-obesity Medication Market Size & Share Report - Grand View Research, 2023.
4. Weight Control and Risk Factor Reduction in Obese Subjects Treated for 2 Years with Orlistat - JAMA, 2000.
5. Orlistat Global Market Report 2024 - GII Research, October 2024.