Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease

NCTNCT00529204 (opens ClinicalTrials.gov in a new tab)Other id200715325Other idH80-MC-X006
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
1 participants (actual)
Sponsor
University of California, Davis · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2007
Primary completion
Jul 2009
Completion
Feb 2010
First posted
14 Sept 2007 (estimated)
Last update posted
20 Jun 2017
Conditions
Diabetes Complications · Fatty Liver

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008200920102011
  1. Ph 2

    Effects Of Exenatide On Liver Biochemistry, Liver Histology And Lipid Metabolism In Patients With Fatty Liver Disease

    NCT00529204

    Oct 2007 to Feb 2010

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are common complications of type 2 diabetes and leading causes of liver disease in the US and Europe. The prevalence of NAFLD and NASH are expected to become a major cause of liver disease related deaths and liver transplantation. Currently, there are no specific therapies that alter the natural history of NAFLD.Preliminary evidence suggests that exenatide (Byetta®) may have several beneficial direct and indirect effects on NAFLD and liver lipid metabolism.

Interventions

  • exenatideDrug

Arms1

  • Experimental

    Exenatide

    exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy

    Time frame · 24 weeks

Secondary outcomes(2)

  1. Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis

    Time frame · 24 weeks

    Registry description

    Steatosis was grades on a scale of 0 (\< 5%); 1 (5%- 33%); 2 (\> 33% - 66%); and 3 (\> 66%). Inflammation was graded on a scale of 0 (No foci); 1 (\< 2 foci per 200 X field); 2 (2-4 foci per 200 X field); and 3 (\>4 foci per 200 X field) Fibrosis was graded on a scale of 0 (None); 1 (Mild periportal or perisinusoidal); 2 (Moderate periportal or perisinusoidal); 3 (Bridging fibrosis); and 4 (cirrhosis)

  2. Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes

    Time frame · 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 24 weeks

Reduction in Serum ALT From Baseline to 24 Weeks of Exenatide Therapy

GroupValue (IU)
Exenatide61
Secondary and other outcome results(2)
Secondary outcomeNumber· 24 weeks

Changes in Components of Liver Histology at Baseline and Week 24 Including Steatosis, Inflammation and Fibrosis

GroupValue (units on a scale)
Exenatide-1
Secondary outcomeNumber· 24 weeks

Safety of Exenatide in Patients With NAFLD and Type 2 Diabetes

GroupValue (adverse events)
Exenatide0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatideexenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24 exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24–0 / 10 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2007

13 results

Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.

Buse et al. 2007Clinical therapeuticscited by 194

PMID 17379054DOI 10.1016/j.clinthera.2007.01.015PUB-17379054

Full text at the publisher13 results
Publisher pageSee results (13)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age \>18 years, \< 70 years, inclusive * Type 2 diabetes on stable doses of sulfonylurea and/or metformin * Body mass index \> 35 kg/m2 * Presumed diagnosis of NAFLD based upon * an ALT \> 1.5 times the upper limit of reference range, * no evidence of other causes of liver disease and * ultrasound findings compatible with fatty liver Exclusion Criteria: * Clinical signs of cirrhosis as evidenced by any of the following * spider angiomata, * splenomegaly, * ascites * jaundice * encephalopathy * INR \> 1.2 * Platelet count \< 100,000/ml * Serum albumin \< 3.0 g/dL * Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis. * Current use of \> 20 g of alcohol per day or unwillingness to avoid alcohol during the course of the study * Treatment with a thiazolidinedione or exenatide within 6 months of enrolling in the study * AST or ALT \> 10 times the upper limit of normal * Treatment with any investigational drug within 4 weeks of enrollment * Pre-menopausal, fertile women unwilling to use contraceptives during the study period. * Pregnancy or lactation * Initiation or change in dose of hypolipidemic drugs (statins, niacin, cholestyramine are allowed) within 6 months of enrollment * Use of anticoagulation, bleeding disorders or other contraindications to liver biopsy

PepBank is a research reference. Talk to a doctor before you use any peptide.