NCT05832229RecruitingPhase 2

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

Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 260 (estimated)
First submitted: 24 Mar 2023
Start date: 7 Dec 2023
Primary completion date: 31 Aug 2029
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diseases: Hepatitis B, Fatty liver disease (MASLD/MASH)
NCT number: NCT05832229

What you commit to

Study type: Interventional · Phase 2
Planned participants: 260
From 7 Dec 2023 to the primary completion date, 31 Aug 2029
13 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age 18-75 years
Cirrhosis due to NAFLD, ALD, or chronic viral hepatitis (treated HBV or HCV)
Clinical diagnosis of cirrhosis as defined by 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 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
Two measures of VCTE: one at screening and one at the open-label dispense study visit, meeting the following criteria:
- The first measure must be ≥ 15.0 kPa.
- 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 ≥ 15.0 kPa.
- 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 \<8
Provision of written informed consent. Exclusion Criteria
-
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)
- colchicine
- cyclosporin
- Additional medications that will be excluded:
- atazanavir/ritonavir capmatinib darolutamide dasabuvir/ombitasvir/paritaprevir/ritonavir ledipasvir/sofosbuvir elbasvir/grazoprevir erythromycin lopinavir/ritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir/velpatasvir/voxilaprevir sofosbuvir/velpatasvir tafamidis tamoxifen teriflunomide
- \*If exposure was for 7 or less days for one of these medications can consider enrollment after 28 days from final dose.
Presence of portal or hepatic vein thrombosis
Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism
Receiving an elemental diet or parenteral nutrition
Chronic pancreatitis or pancreatic insufficiency
Etiology of cirrhosis other than ALD, NAFLD, or viral hepatitis (excluded diagnoses include cryptogenic immune-mediated such as AIH, PSC and PBC, cardiac cirrhosis or Fontan-associated liver disease, A1AT, Wilson's disease, etc.)
Conditions which may confound study outcome:
- Unstable or active inflammatory bowel disease b. Active infection c. Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years d. Prior solid organ or hematopoietic cell transplant e. Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks f. Current liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen.
Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol.
The following laboratory abnormalities within 90 days of screening:
- Hemoglobin \<10 g/dL b. Albumin \<3.0 g/dL c. Prolonged international normalized ratio (INR) \>1.5 d. Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction) e. Direct bilirubin ≥ 0.9 f. Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.
Kidney function abnormalities including:
- Dialysis
- Baseline eGFR \< 30 cc/min with CKD-Epi equation
- Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection
Recent (within 48 weeks) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding
Untreated chronic hepatitis B or C infection
- HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12
- HBV eligible if an HBV DNA \<100 IU/mL within the last 48 weeks and on treatment
Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L within the past 24 weeks or alkaline phosphatase (ALP) ≥ 300.
Documented history of intolerance to statins
Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks
Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening
Pregnancy, planned pregnancy or breastfeeding
Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial.
Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.
Failure or inability to provide informed consent.
East Asian Descent within one degree of relatedness (e.g., if the participant's parents are of East Asian descent)

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Michigan Coordinator of this site? Confirm its status	Ann Arbor	United States	Recruiting
Cleveland Clinic Coordinator of this site? Confirm its status	Cleveland	United States	Recruiting
Duke Liver Center Coordinator of this site? Confirm its status	Durham	United States	Recruiting
University of California San Diego NAFLD Research Center Coordinator of this site? Confirm its status	La Jolla	United States	Recruiting
LAC & USC Medical Center Coordinator of this site? Confirm its status	Los Angeles	United States	Recruiting
Keck Medical Center of USC Coordinator of this site? Confirm its status	Los Angeles	United States	Recruiting
University of Miami Health System Coordinator of this site? Confirm its status	Miami	United States	Recruiting
Columbia University Iriving School of Medicine Coordinator of this site? Confirm its status	New York	United States	Recruiting
New York Presbyterian/Weill Cornell Coordinator of this site? Confirm its status	New York	United States	Recruiting
Virginia Commonwealth University Coordinator of this site? Confirm its status	Richmond	United States	Recruiting
Mayo Clinic Coordinator of this site? Confirm its status	Rochester	United States	Recruiting
UCSF Medical Center Coordinator of this site? Confirm its status	San Francisco	United States	Recruiting
UCSF - Zuckerberg San Francisco General Hospital and Trauma Center Coordinator of this site? Confirm its status	San Francisco	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.