NCT00650546

Role of Exenatide in NASH-a Pilot Study

Role of Exenatide in Treatment of NASH-a Pilot Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

We hypothesize that exenatide (Byetta), a GLP-1 agonist administered subcutaneously for 24-28 weeks improves liver histology in diabetic patients with biopsy-proven NASH.

Detailed description

Eight adult patients with known type 2 DM(Diabetic) and biopsy-proven NAFLD were treated with 5-10 mcg subcutaneous exenatide for 28 weeks. Liver histology was assessed using the NAFLD Activity Score (NAS) prior to therapy and after 28 weeks of therapy. We used the following criteria to define our primary outcome: (i) no worsening of fibrosis score, (ii) improved score by at least one point in hepatocyte ballooning, (iii) either (a) improvement in NAS by 2 or more points spread across at least two of the three NAS components, or (b) post-treatment NAS equal or greater than 3.

Conditions

• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Exenatide	5 mcg twice a day titrated to 10 mcg twice a day

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-04-01
• Last updated: 2017-04-11
• Results posted: 2016-05-12

Locations

3 sites across 1 country: United States