NASH Treatment Study
Researchers at Washington University School of Medicine are partnering with individuals who know or suspect they have nonalcoholic steatohepatitis with stage 2 or stage 3 hepatic fibrosis to evaluate how a medication could help. Join our research study today!
Fast Facts
known or suspected Fatty Liver Disease
18 Years and Older
meal & travel compensation Provided
Conducted in St. Louis, MO
Study Background
Non-alcoholic steatohepatitis (NASH) is a progressive liver disease where fat accumulates in the liver and causes inflammation and scarring in the liver (called fibrosis). NASH evolves from non-alcoholic fatty liver disease, and if left untreated, the disease continues to progress and may lead to advanced fibrosis and liver cirrhosis.
This is a clinical trial for adults 18 years of age and older with NASH and liver fibrosis stage 2 or 3. The purpose of the trial is to evaluate if an oral investigational drug (lanifibranor) is a safe and effective potential treatment option for NASH. The clinical trial will evaluate if the investigational drug reduces the scars on your liver (fibrosis), resolves NASH, delays or stops damage to liver function, and improves the way you feel throughout the trial.
There are currently no approved drug therapies for the prevention or treatment of this condition, so your participation in this clinical trial is essential to finding treatment options for people living with NASH. Join our research study today!
Study Background
Non-alcoholic steatohepatitis (NASH) is a progressive liver disease where fat accumulates in the liver and causes inflammation and scarring in the liver (called fibrosis). NASH evolves from non-alcoholic fatty liver disease, and if left untreated, the disease continues to progress and may lead to advanced fibrosis and liver cirrhosis.
This is a clinical trial for adults 18 years of age and older with NASH and liver fibrosis stage 2 or 3. The purpose of the trial is to evaluate if an oral investigational drug (lanifibranor) is a safe and effective potential treatment option for NASH. The clinical trial will evaluate if the investigational drug reduces the scars on your liver (fibrosis), resolves NASH, delays or stops damage to liver function, and improves the way you feel throughout the trial.
There are currently no approved drug therapies for the prevention or treatment of this condition, so your participation in this clinical trial is essential to finding treatment options for people living with NASH. Join our research study today!
Additional Information
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- 18 years or older
- Known or suspected nonalcoholic steatohepatitis (NASH) with stage 2 or stage 3 hepatic fibrosis
- Stable doses of medications for 3 months
- Weight stable for 6 months
- No history of liver transplantation
Exclusion Criteria:
- Liver disease from something other than nonalcoholic steatohepatitis
- Use of insulin
- Cirrhosis of the liver
Once enrolled, this 38-week study involves:
Screening
- Informed consent
- Medical history and review of current prescriptions
- Lab tests
- Review of historical liver biopsy or perform a liver biopsy
- Review of eligibility criteria
- Review diet and lifestyle
- ECG and elastography
Randomization into 1 of 3 groups:
- Lanifibranor, 800mg/day
- Lanifibranor, 1200mg/day
- Placebo
Treatment Period, Part A
- Daily pills for 72 weeks to a maximum of 120 weeks
- Attend a maximum of 10 on-site visits and 3 phone visits so the study doctor can check your health
Week 72 visit:
- Tests, questionnaires, & potential liver biopsy
Treatment Period, Part B:
- Daily pills (all lanifibranor, not placebo)
- Attend 5 on-site visits and 1 phone visit so the study doctor can check your health
End-of-study visit:
- After 48 weeks of treatment in Part B, you will stop the treatment, and there will be a final follow-up visit in approximately 4 weeks. This is the final planned study visit to evaluate safety.
