Actively Recruiting
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-01-13
256
Participants Needed
13
Research Sites
299 weeks
Total Duration
On this page
Sponsors
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Cirrhosis caused by nonalcoholic steatohepatitis, alcohol-associated liver disease, or treated chronic viral hepatitis
- Clinical diagnosis of cirrhosis confirmed by liver biopsy within 5 years showing advanced fibrosis, or at least two criteria including imaging evidence, liver stiffness measurements, varices, or specific blood test results
- Two vibration-controlled transient elastography liver stiffness measurements at screening and randomization, both at least 15 kilopascal, taken 2 hours to 60 days apart, with a mean of at least 15 kilopascal and both measures at or below 50 kPa
- Compensated cirrhosis defined by no ascites, hepatic encephalopathy, or variceal bleeding currently or within the last 48 weeks, or stable condition if prior decompensation
- Child-Pugh score less than 8
- Ability to provide written informed consent
You will not qualify if you...
- Current or recent (within 24 weeks) use of statins
- Indication for statin therapy due to prior cardiovascular events, familial hypercholesterolemia, or high LDL cholesterol (≥190 mg/dL)
- Myocardial infarction, unstable angina, transient ischemic event, or stroke within 24 weeks
- Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher at screening
- Limitations preventing attending study visits
- Prisoner status
- Known or prior liver cancers such as hepatocellular carcinoma or cholangiocarcinoma
- Presence of portosystemic shunts or related surgeries
- Recent or current use of medications causing liver fibrosis or increasing risk of rosuvastatin side effects
- Portal or hepatic vein blood clots
- Untreated or unstable hypothyroidism
- Receiving elemental diet or parenteral nutrition
- Chronic pancreatitis or pancreatic insufficiency
- Cirrhosis due to causes other than alcohol, NAFLD, or viral hepatitis
- Conditions affecting study results such as active inflammatory bowel disease, active infection, recent cancer, organ transplant, recent or planned bariatric surgery, or serious unrelated organ failure
- Medical or psychiatric conditions interfering with safety or adherence
- Laboratory abnormalities including low hemoglobin, low albumin, prolonged INR, high bilirubin, uncontrolled diabetes
- Severe kidney dysfunction or proteinuria
- Recent or current hepatic decompensation
- Untreated chronic hepatitis B or C infection
- Elevated liver enzymes above specified limits
- History of statin intolerance
- Serious illnesses limiting life expectancy to under 96 weeks
- Active illicit drug use (other than THC) in past 24 weeks
- Pregnancy, planned pregnancy, or breastfeeding
- Participation in other medication trials within 24 weeks
- Significant muscle pain or history of myasthenia gravis
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of California San Diego NAFLD Research Center
La Jolla, California, United States, 92035
Actively Recruiting
2
Keck Medical Center of USC
Los Angeles, California, United States, 90033
Actively Recruiting
3
LAC + USC Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
Actively Recruiting
5
UCSF Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
6
University of Miami Health System
Miami, Florida, United States, 33122
Actively Recruiting
7
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55901
Actively Recruiting
9
New York Presbyterian/Weill Cornell
New York, New York, United States, 10021
Actively Recruiting
10
Columbia University Iriving School of Medicine
New York, New York, United States, 10031
Actively Recruiting
11
Duke Liver Center
Durham, North Carolina, United States, 27710
Actively Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44192
Actively Recruiting
13
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
C
Crystal Santillanes, MS
CONTACT
M
Mary Beth Tull, MBA, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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