A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00492700

Acronym

FLIRT

Enrollment

Registered

2007-06-27

Start date

2003-01-31

Completion date

Unknown

Last updated

2007-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Steatohepatitis

Keywords

steatosis,, fibrosis,, diabetes,, obesity

Brief summary

This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).

Detailed description

Phase one : A double blind randomized placebo controlled trial of rosiglitazone * 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year. * after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis Phase II extension open label trial All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.

Interventions

DRUGrosiglitazone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histologically proven NASH with steatosis \>= 20% * Increased serum ALT

Exclusion criteria

* bland steatosis * daily alcohol \> 20/30 g (women/men) * any other cause of liver disease * secondary NASH including drug-induced steatohepatitis * treatment with insulin or glitazones * cardiac insufficiency * Hb \< 10 g/dl

Design outcomes

Primary

Measure	Time frame
improvement in steatosis	—

Secondary

Measure	Time frame
improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026