Purpose of this Study
We are doing this study to find out if a drug called rosuvastatin (an FDA-approved medication for lowering cholesterol) can help reduce symptoms and extend the life expectancy of people with liver cirrhosis. Although rosuvastatin is an approved and commonly prescribed drug, it is not approved for the treatment of cirrhosis.
Who Can Participate?
Eligibility
Adults ages 18-75 who:
- Are diagnosed with liver cirrhosis that is caused by alcoholic liver disease, fatty liver disease, or viral hepatitis
- Are not using a statin (cholesterol lowering) medication
- Do not have any history of esophageal bleeding or mental confusion caused by liver disease
- Have not had any ascites (fluid buildup in the abdomen) in the past 12 months
- Have no history of stroke, heart attack, or liver cancer
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (by chance) to either take rosuvastatin or a placebo (inactive substance that has no drug in it).
Regardless of your study assignment, everyone who participates in this study will:
- Have physical exams
- Have strength tests and mental exams
- Have blood draws
- Have imaging tests (MRI and fibroscan)
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Liver Cirrhosis Network (LCN)
Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study
Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study
Principal Investigator
Cynthia
Moylan
Protocol Number
PRO00113706
NCT ID
NCT05832229
Phase
II
Enrollment Status
Open to Enrollment