Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B, Cirrhosis Advanced, Cirrhosis Infectious, Cirrhosis Alcoholic, Cirrhosis Due to Hepatitis C

In brief

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.

Key facts

Study ID: NCT05832229
Run by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
People needed: 256
Starts: 2023-12-07
Expected to finish: 2029-08-31
Last updated by the study team: 2026-06-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18-75 years
Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)
Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
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\&gt;2.67 or platelets \&lt;150/mL within 6 months prior to consent or during Screening
Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
The first measure must be ≥ 15 kilopascal.
The two measures must be at least 2 hours apart and no more than 60 days apart from one another.
The mean of two measurements must be ≥ 15 kilopascal.
Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa
Compensated defined by:
Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.
If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and/or rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.
Child-Pugh score \&lt;8
Provision of written informed consent.

You may not qualify if…

Currently on a statin or any statin exposure within 24 weeks prior to consent.
Known indication for statin therapy, defined as:
Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
Fasting LDL-C ≥ 190 mg/dL
Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.
Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.
Patients with limitations in attending study visits.
Prisoners.
Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.
Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.
Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:
amiodarone
methotrexate
warfarin
Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:
fenofibrate
erythromycin
gemfibrozil
niacin (500 mg or more)
HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent
colchicine
cyclosporin
Additional medications that will be excluded:
atazanavir/ritonavir capmatinib darolutamide dasabuvir/ombitasvir/paritaprevir/ritonavir ledipasvir/sofosbuvir elbasvir/grazoprevir erythromycin glecaprevir/pibrentasvir lopinavir/ritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir/velpatasvir/voxilaprevir sofosbuvir/velpatasvir tafamidis teriflunomide

Where it is running

Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
Keck Medical Center of USC — Los Angeles, California, United States (enrolling)
LAC + USC Medical Center — Los Angeles, California, United States (enrolling)
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California, United States (enrolling)
UCSF Medical Center — San Francisco, California, United States (enrolling)
University of Miami Health System — Miami, Florida, United States (enrolling)
University of Michigan — Ann Arbor, Michigan, United States (enrolling)
Mayo Clinic — Rochester, Minnesota, United States (enrolling)
New York Presbyterian/Weill Cornell — New York, New York, United States (enrolling)
Columbia University Iriving School of Medicine — New York, New York, United States (enrolling)
Duke Liver Center — Durham, North Carolina, United States (enrolling)
University of California San Diego NAFLD Research Center — La Jolla, California, United States (enrolling)
Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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