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

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.

Timeline

Start

2003-10

Primary completion

—

Completion

2006-12

Outcome

Missed primary endpoint

paper Orlistat did not enhance weight loss or improve liver enzymes, measures of insulin resistance, and histopathology. PMID 19053049 ↗

Publications

• Harrison SA, Fecht W, Brunt EM, Neuschwander-Tetri BA. Orlistat for overweight subjects with nonalcoholic steatohepatitis: A randomized, prospective trial. Hepatology. 2009 Jan;49(1):80-6. doi: 10.1002/hep.22575.

Drugs

Indications