Statins for the Treatment of NASH (NCT04679376) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Statins for the Treatment of NASH
United States70 participantsStarted 2023-01-25
Plain-language summary
The purpose of this research study is to determine whether the study drug, atorvastatin (Lipitor®), is safe and effective in improving the features of NASH.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Definite NASH on a liver biopsy obtained ≤ 90 days prior to randomization with a NAFLD activity score (NAS) of ≥ 4 with at least 1 in each component of the NAS according to NASH CRN grading52
* Fibrosis stage ≥ 2 as assessed by liver biopsy
* Not currently on statin therapy
* Provision of written informed consent
* Agree to use of effective contraceptive measures if female of child bearing potential.
Exclusion Criteria:
* The presence of any of the following will exclude a subject from study enrollment: Any chronic liver disease other than NASH (i.e., drug-induced, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, A1AT deficiency, Wilsons disease)
* Cirrhosis, as assessed clinically or histologically
* Presence of vascular liver disease
* BMI ≤ 25 kg/m2
* Excessive alcohol use (\> 20 g/day) within the past 2 years
* AST or ALT \> 250 U/L.
* Type 1 diabetes mellitus
* Bariatric surgery in the past 5 years.
* Weight gain of \> 5% in past 6 months or \> 10% change in past 12 months.
* Inadequate venous access
* HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or HCV RNA positive.
* Receiving an elemental diet or parenteral nutrition
* Chronic pancreatitis or pancreatic insufficiency
* Any history of complications of cirrhosis (i.e. ascites, hepatic encephalopathy, or portal hypertensive bleeding), even if absent or optimized with medical management at time of screening
*…
What they're measuring
1
Change in NASH as measured by improvement in NAS score Improvement in NAS score (≥ 2 points) with no worsening in fibrosis stage (≥1 point) OR improvement in fibrosis with no worsening of NASH (change in the NAS score of ≤ 0 points).