Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)

Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00699036

Enrollment

165

Registered

2008-06-17

Start date

2007-04-30

Completion date

2009-08-31

Last updated

2009-06-19

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

Conditions

Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Keywords

nonalcoholic steatohepatitis (NASH), fatty liver, insulin resistance

Brief summary

The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?

Interventions

DRUGavandia

4 mg twice daily

DRUGmetformin

500 mg twice daily for 48 weeks

DRUGlosartan

losartan 50 mg once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients between 18-70 years old 2. Negative urine pregnancy test in females 3. History of elevated liver associated enzymes (ALT \> 40) 4. Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH

Exclusion criteria

1. ALT greater than three times normal 2. NYHA class 3 or 4 heart failure 3. Any congestive heart failure patient on insulin 4. Patients on one of the 3 study drugs within the past 3 months prior to enrollment 5. Alcohol consumption \>20 gm/day in a female and \> 30 gm/day in a male 6. Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis 7. Serum creatinine on initial screening of greater than 1.4 8. Known hypersensitivity to rosiglitazone, metformin, or losartan 9. Known history of diabetic ketoacidosis 10. Female that is breastfeeding 11. Insulin dependent diabetic

Design outcomes

Primary

Measure	Time frame
liver biopsy histologic improvement	end of study

Secondary

Measure	Time frame
serum transaminases	throughout study (ongoing)

Countries

United States

Outcome results

None listed

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