RecruitingCirrhosisCirrhosis, LiverCirrhosis Early
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
Eligible age
18–75 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
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About this study
This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
You may qualify if…
- ✓ 1. Age 18-75 years
- ✓ 2. Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)
- ✓ 3. Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
- ✓ 1. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
- ✓ 2. At least 2 of the following:
- ✓ i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled transient elastography within 48 weeks prior to consent or during Screening ≥15 kilopascal or magnetic resonance elastography within 48 weeks prior to consent or during Screening ≥5 kilopascal iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: Fibrosis-4\>2.67 or platelets \<150/mL within 6 months prior to consent or during Screening
- ✓ 4. Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
- ✓ 1. The first measure must be ≥ 15 kilopascal.
You may not qualify if…
- ✕ 1. Currently on a statin or any statin exposure within 24 weeks prior to consent.
- ✕ 2. Known indication for statin therapy, defined as:
- ✕ 1. Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
- ✕ 2. Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
- ✕ 3. Fasting LDL-C ≥ 190 mg/dL
- ✕ 3. Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.
- ✕ 4. Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.
- ✕ 5. Patients with limitations in attending study visits.
Where it's recruiting
California
La Jolla · Los Angeles · San Francisco
Florida
Miami
Michigan
Ann Arbor
Minnesota
Rochester
New York
New York
North Carolina
Durham
Ohio
Cleveland
Virginia
Richmond
Source: ClinicalTrials.gov · NCT05832229 · last updated 2026-06-02