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

What Was Tested

This registered phase 4 trial tested Exenatide for fatty liver & elevated liver enzymes.

It had two arms (groups): Exenatide (active comparator) and Placebo (placebo comparator).

Drug (including placebo).

The registry classes the interventions as drug.

More on the Plan

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.

Liver biopsies will be performed after 24 weeks of treatment.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age between 18 and 75 years, inclusive. Patients present with histologically proven non-alcoholic steatohepatitis ascertained by the single center pathologist between visit 1 and 2. First liver biopsy was obtained not later than 6 months before visit 1.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: patients with evidence of viral or autoimmune hepatitis (positive testing for hbsag, anti-hcv or anti-hiv, pos. ama-screen, ana-titer \> 1:160); patients with inherited liver diseases (e.g. wilson's disease, hemochromatosis); patients have decompensated liver cirrhosis (child-pugh score \>7).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

The Exenatide group and the comparison group ran side by side rather than switching.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2008-07 with completion listed for 2010-09.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: histological activity of NASH (steatosis, necroinflammation, ballooning) (time frame: 24 weeks).

It also tracked 1 secondary outcome, for example Liver fibrosis, as determined using the fibrosis score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 13 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; no results are posted to the registry yet, so nothing here describes outcomes.

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