Skip to content

Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Role of Exenatide in NASH-a Pilot Study

Short name NAFLD

NCTNCT00650546 (opens ClinicalTrials.gov in a new tab)Other idDK61737Other idU01DK061737

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
8 participants (actual)
Sponsor
Indiana University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Aug 2006
Primary completion
Aug 2010
Completion
Aug 2010
First posted
1 Apr 2008 (estimated)
Last update posted
11 Apr 2017
Conditions
Nonalcoholic Fatty Liver Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008200920102011
  1. Ph 2/3

    NAFLD

    NCT00650546

    Aug 2006 to Aug 2010

Registry summary

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

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.

Interventions

  • ExenatideDrug

Arms1

  • Experimental

    A pre treatment NAS score

    liver biopsy score pre treatment with exenatide 5 micrograms SQ (sub-cutaneous) twice a day titrated to 10 mcg SQ twice a day as tolerated

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Patients With Improvement in Liver Histology After Treatment With Exenatide

    Time frame · between baseline and 24-28 weeks after initiating treatment

    Registry description

    Number of patients with liver histology improved with exenatide. The improvement of liver histology was defined as (1) no worsening of the fibrosis score, (11) improved score by at least one point in hepatocyte ballooning, and (111) either (a) improvement in NAS (NAFLD Activity Score) by two points spread across as least two of the three NAS components, or by (B)post-treatment NAS\<3.

  2. Change in NAS

    Time frame · Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.

    Registry description

    The NAFLD Activity Score (NAS) is an underweight sum of steatosis (score 0-3), inflammation (score 0-3), ballooning scores (0-2). The NAS can range from 0-8 with the higher score indicating more aggressive disease.

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· between baseline and 24-28 weeks after initiating treatment

Number of Patients With Improvement in Liver Histology After Treatment With Exenatide

GroupValue (participants)
Treatment With Exenatide8
Primary outcomeMean· Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq.

Change in NAS

GroupValue (units on a scale)Spread
Individuals Who Recieved Treatment With Exenatide-1.51.66

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide GroupExenatide 5 micrograms SQ twice a day titrated to 10 mcg SQ twice a day as tolerated Exenatide : 5 mcg twice a day titrated to 10 mcg twice a day–0 / 82 / 8

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

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Clinical trial · 2003

9 results

Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting plasma glucose in subjects with type 2 diabetes.

Kolterman et al. 2003The Journal of clinical endocrinology and metabolismcited by 389

PMID 12843147DOI 10.1210/jc.2002-021545PUB-12843147

Rights unknown9 results

Indexing hint: Animal study · 1999

6 results

Once daily injection of exendin-4 to diabetic mice achieves long-term beneficial effects on blood glucose concentrations.

Greig et al. 1999Diabetologiacited by 150

PMID 10027577DOI 10.1007/s001250051111PUB-10027577

Rights unknown6 results

More studies

1 study on this page

Indexing hint: Observational study · 1990

Purification and structure of exendin-3, a new pancreatic secretagogue isolated from Heloderma horridum venom.

Eng et al. 1990The Journal of biological chemistrycited by 48

PMID 1700785DOI 10.1016/s0021-9258(17)30498-2PUB-01700785

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultKenny PR, Brady DE, Torres DM, Ragozzino L, Chalasani N, Harrison SA. Exenatide in the treatment of diabetic patients with non-alcoholic steatohepatitis: a case series. Am J Gastroenterol. 2010 Dec;105(12):2707-9. doi: 10.1038/ajg.2010.363. No abstract available. PMID 21131943

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 99 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Well documented NASH based on clinical and histological criteria. Liver biopsy must have been obtained within 12-months prior to initiation of the study. * Subjects must have known diabetes (either diet controlled or only on Metformin or sulfonylureas such as glyburide or glipizide). * Subjects must be 18 year or older. Exclusion Criteria: * Co-existing etiologies for chronic liver disease (hepatitis B or C, autoimmune or hemochromatosis, etc.). * Clinical or histological evidence of cirrhosis. * Alanine aminotransferase or aspartate aminotransferase \> 300 IU/L. * Uncontrolled diabetes (hemoglobin A1C greater than or equal to 9%). * Insulin or TZD dependant DM. * Known human immunodeficiency virus infection. * Current or history of significant alcohol consumption within past 5 years. Significant alcohol consumption is defined as \>20 grm/day in females and \>30 grms/day in males or if alcohol consumption cannot satisfactorily be quantified. * Serum creatinine of greater than or equal to 2 mg/dl. * Active, serious medical disease (cardiac, renal, pulmonary, dermatologic, psychiatric illness) with likely life expectancy less 5 years. * Current or previous malignancy with expected life expectancy less than 5-years (other than basal cell cancer of the skin). * Use of drugs historically associated with NASH. * Histological evidence of malignancy, 4+ iron deposition, or any other type of liver disease. * Active substance abuse, such as alcohol,inhaled or injection drugs with the previous one year. * Known intolerance or allergy to exenatide (Byetta). * History of neuroglycopenia. * Women of childbearing potential must have had a negative pregnancy test prior to starting the study and should be willing to avoid pregnancy during the study period. * Women must not be nursing.

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