NCT01208649

Effects of Exenatide (Byetta®) on Liver Function in Patients With Nonalcoholic Steatohepatitis (NASH)

Effects of Exenatide (Byetta®) on Biochemical and Histological Parameters of Liver Function in Patients With Nonalcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Ruhr University of Bochum · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to test the hypothesis that 24 weeks of treatment with exenatide will improve the histological acitvity of NASH (steatosis,necroinflammation, ballooning), summarized in the recently introduced NASH-score in patients with normal, impaired or diabetic glucose tolerance compared to dietary guidance alone.

Detailed description

Non alcoholic steatohepatitis (NASH), a chronic liver disease characterized by insulin resistance, accumulation of hepatic fat and hepatocellular necroinflammation, has been recognized as a leading cause of (cryptogenic) liver cirrhosis in developed countries. Given the rising prevalence of NASH and the associated socio-economic burden associated, novel therapeutic options are warranted. The incretin mimetic Exenatide (Byetta®) exhibits strong glucoregulatory activities through its multiple biological effects. In addition, exenatide treatment has been shown to improve lipid homeostasis and reduce body weight. Since the development of NASH has been tightly linked to the presence of obesity, hyperlipidaemia and diabetes, this study will examine, whether 24 weeks of treatment with exenatide will also result in improvements in liver function in patients with NASH. 60 patients with histologically proven NASH will be randomized to receive either exenatide (2 x 5 µg s.c. for 4 weeks, 2 x 10 µg thereafter) or placebo treatment, in a 1:1 ratio. Liver biopsies will be performed after 24 weeks of treatment. In addition, a non-invasive assessment of hepatic mitochondrial function will be carried-out using a 13C-methionine breath test at baseline, and at weeks 12 and 24. Insulin sensitivity and glucose tolerance will be assessed by a hyperinsulinaemic-euglycaemic clamp (baseline and week 24) and an oral glucose tolerance test (baseline, weeks 12 and 24). Hepatic fat content will be measured by magnetic resonance tomography. Liver enzymes will be monitored closely throughout the study period. These studies will clarify whether exenatide treatment, in addition to its beneficial effects on glucose homeostasis and body weight, will also result in improvements of liver function in patients with NASH.

Conditions

• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Exenatide	Exenatide; 48 weeks 10 microg injection s.c., twice daily, before the morning and evening meal with a four week wash-in phase with 5 microg injection s.c.twice daily

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-09-24
• Last updated: 2010-09-24

Locations

1 site across 1 country: Germany