Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
NCT00160407 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2007-11-20
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.
Conditions
- Fatty Liver
- Hepatitis
Interventions
- DRUG
-
Orlistat (Xenical)
- BEHAVIORAL
-
1400 kcal diet (30% fat)
Sponsors & Collaborators
- collaborator INDUSTRY
-
St. Louis University
lead OTHER
Principal Investigators
-
Brent A Tetri, MD · St. Louis University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-31
- Completion
- 2006-12-31
Countries
- United States
Study Locations
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