Role of Exenatide in NASH-a Pilot Study

Plain-language guide to NCT00650546: phase 2, phase 3 interventional trial of Exenatide, fatty liver & elevated liver enzymes, 8 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00650546
Phase: phase 2, phase 3
Status: completed
Start: 2006-08
Completion (planned or actual): 2010-08
Participants: 8 (actual)
Design: na, open label (everyone knows who gets what), other
Conditions studied: Nonalcoholic Fatty Liver Disease
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 2, phase 3 trial tested Exenatide for fatty liver & elevated liver enzymes.

It had 1 arm (groups): A pre treatment NAS score (experimental).

The registry classes the interventions as drug.

More on the Plan

Liver histology was assessed using the NAFLD Activity Score (NAS) prior to therapy and after 28 weeks of therapy.

Who Took Part

8 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 be 18 year or older.

The full record lists 3 inclusion and 17 exclusion criteria; among the exclusions: co-existing etiologies for chronic liver disease (hepatitis b or c, autoimmune or hemochromatosis, etc.); clinical or histological evidence of cirrhosis; insulin or tzd dependant dm.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Exenatide study: the fatty liver & elevated liver enzymes participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-08 with completion listed for 2010-08.

It ran at 3 sites in United States (3).

Its stated primary purpose is other.

What Was Measured

Primary outcome: Change in NAS (time frame: Between baseline and 28 weeks of treatment with exenatide, sub q, 5-10 mcq).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Exenatide in 8 people with fatty liver & elevated liver enzymes.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, Fatty liver & elevated liver enzymes research.

Our Notes on the Compound

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.