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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Collaborator: Hoffmann-La Roche
• Treatments: Orlistat

Criteria

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