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
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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 NAFLD, ALD, or chronic viral hepatitis (treated HBV or HCV)
- ✓ 3. Clinical diagnosis of cirrhosis as defined by investigator confirmation and the following:
- ✓ a. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR b. 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: VCTE within 48 weeks prior to consent or during Screening ≥15.0 kPa or MRE within 48 weeks prior to consent or during Screening ≥5 kPa iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: FIB-4\>2.67 or platelets \<150/mL within 6 months prior to consent or during Screening
- ✓ 4. Two measures of VCTE: one at screening and one at the open-label dispense study visit, meeting the following criteria:
- ✓ 1. The first measure must be ≥ 15.0 kPa.
- ✓ 2. The two measures must be at least 2 hours apart and no more than 60 days apart from one another.
- ✓ 3. The mean of two measurements must be ≥ 15.0 kPa.
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 2026-09-28