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Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00160407
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 20, 2007
Hoffmann-La Roche
Information provided by:
St. Louis University

Brief Summary:
The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH.

Condition or disease Intervention/treatment Phase
Fatty Liver Hepatitis Drug: Orlistat (Xenical) Behavioral: 1400 kcal diet (30% fat) Phase 4

Detailed Description:

Previous studies have suggested that steady weight loss over time will result in improvement in aminotransferases, and more importantly, underlying histopathology in patients with NASH. A total of 50 biopsy-proven NASH patients will be enrolled in a prospective, randomized fashion. Twenty-five patients have been enrolled at the primary study site at Saint Louis University. Recruitment of the next 25 patients is taking place at a study subsite at Brooke Army Medical Center in San Antonio, Texas.

This will be an open-label study comparing an established weight loss program (1400-calorie diet with 30% fat) plus daily vitamin E (800 IU) and a daily multivitamin to the same weight loss program, daily vitamin E (800 IU) and multivitamin, plus orlistat (120 mg), three times daily for 36 weeks.

Data to be collected from prospective patients includes demographic information, such as age, sex, past medical history, medications, height and weight. Biochemical data to be collected from prospective patients includes liver enzymes, measures of insulin resistance to include, insulin levels, lipid panel, hemoglobin A1C, free fatty acids, complete blood count, coagulation studies, and vitamin E levels. Blood will also be collected and stored for markers of inflammation and fibrosis, such as C reactive protein and TNF-alpha. A liver biopsy will be obtained at the completion of the study for both histopathologic analysis and RNA analysis.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
Study Start Date : October 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Primary Outcome Measures :
  1. The primary endpoint is weight loss leading to improvement in the global necroinflammatory and fibrosis scores on liver biopsies. A change of one point in the necroinflammatory grade or fibrosis stage will be considered statistically significant.

Secondary Outcome Measures :
  1. BMI,ALT,Serum free fatty acids,HOMA-IR (fasting insulin x fasting glucose/22.4)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Liver biopsy obtained no more than 24 months before randomization with a pathology report confirming that the histological diagnosis is consistent with NASH
  • Compensated liver disease with the following laboratory parameters at the entry visit:

    • Hemoglobin values of greater than or equal to 12 gm/dl for females or 13 gm/dl for males
    • WBC count > 3,000/mm3
    • Neutrophil count > 1,500/mm3
    • Platelets > 70,000/mm3
    • Albumin >3.0 g/dl
  • Serum creatinine <1.4mg/dl
  • Ability to give informed consent
  • Alanine aminotransferase (ALT) greater than or equal to 40 U/L
  • BMI > or equal to 27 kg/m2
  • Patients who receive orlistat must agree to participate in Xenicare, a free dietary counseling program provided by Roche (sponsor)

Exclusion Criteria:

  • Any cause for chronic liver disease other than NASH
  • Evidence of decompensated liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
  • History of alcohol consumption of greater than 20 grams per day in the past 2 years
  • Prior surgical procedures to include gastroplasty, jejunoileal or jejunocolic bypass
  • TPN within the past 6 months
  • History of prior organ transplantation
  • Concurrent enrollment in other experimental treatment protocols
  • Use of ursodeoxycholic acid, rosiglitazone, pioglitazone, or metformin within the 6-month period before enrollment
  • Women who are pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00160407

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United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63110
United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Sponsors and Collaborators
St. Louis University
Hoffmann-La Roche
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Principal Investigator: Brent A Tetri, MD St. Louis University
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00160407    
Other Study ID Numbers: 12458
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 20, 2007
Last Verified: November 2007
Keywords provided by St. Louis University:
nonalcoholic steatohepatitis
enzyme inhibitors
insulin resistance
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Body Weight
Signs and Symptoms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents