A pilot study of orlistat treatment in obese, non-alcoholic steatohepatitis patients

Aliment Pharmacol Ther. 2004 Sep 15;20(6):623-8. doi: 10.1111/j.1365-2036.2004.02153.x.


Background: Treatment options for non-alcoholic steatohepatitis (NASH) are limited. Weight loss remains the most recommended therapy. Orlistat is an effective adjunct to dietary weight loss therapy.

Aim: To evaluate the efficacy of orlistat, given for 6 months to patients with obesity and biopsy confirmed NASH.

Methods: Ten obese patients with biopsy proven NASH were enrolled. Orlistat was given with meals for 6 months. Body Mass Index (BMI), liver enzymes, haemoglobin A1c, fasting lipids and glucose were assessed at baseline and at completion of the study. Paired liver histology was obtained.

Results: Six women and four men were enrolled. The mean weight loss was 22.7 lb and ranged from 0 to 24.3%. The following clinical values significantly improved: mean BMI: 43.4-39.8 (P = 0.007); mean haemoglobin A1c (%): 7.14-5.95 (P = 0.021); mean alanine aminotransferase (ALT) (U/L): 93 -54 (P = 0.009); and mean aspartate aminotransferase (AST) (U/L): 79-48 (P = 0.008). Steatosis improved in six patients, and fibrosis improved in three patients.

Conclusions: Orlistat therapy and dietary counselling were associated with significant decreases in body weight, haemoglobin A1c, ALT and AST. A 10% or greater reduction in weight improved steatosis and fibrosis as well as haemoglobin A1c levels in the majority of patients treated for 6 months. Controlled trials of longer duration are warranted to assess for histopathologic improvement as well as cost-efficacy in comparison to diet and exercise alone.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anti-Obesity Agents / therapeutic use*
  • Fatty Liver / complications*
  • Female
  • Humans
  • Lactones / therapeutic use*
  • Male
  • Middle Aged
  • Obesity / complications
  • Obesity / drug therapy*
  • Orlistat
  • Weight Loss


  • Anti-Obesity Agents
  • Lactones
  • Orlistat