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CirrhosisPhase 2LCN RESCUNCT05832229

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

A Phase 2 study testing Rosuvastatin in people with Cirrhosis and Cirrhosis, Liver, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cirrhosis, Cirrhosis, Liver, Cirrhosis Early
What is being tested?
Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
13 sitesUnited States
Study dates
7 Dec 2023to 31 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
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  • 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)

Who cannot join

None listed.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Crystal Santillanes, MS contact

312-503-5536

lcn@northwestern.edu

Mary Beth Tull, MBA, CCRP contact

312-503-4746

mary.tull@northwestern.edu

13 sites in 1 country

United States13 sites, 13 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Elliot Tapper, etapper@med.umich.edu

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44192

    Srinivasan Dasarathy, DASARAS@ccf.org

    Recruiting

  • Duke Liver Center

    Durham, North Carolina, 27710

    Cynthia Ann Moylan, MD, MHS, MS, 919-681-4044, cynthia.moylan@duke.edu

    Mariko Kopping, mariko.kopping@duke.edu

    Recruiting

  • University of California San Diego NAFLD Research Center

    La Jolla, California, 92035

    Rohit Loomba, roloomba@health.ucsd.edu

    Recruiting

  • Keck Medical Center of USC

    Los Angeles, California, 90033

    Norah Terrault, norah.terrault@med.usc.edu

    Recruiting

  • LAC + USC Medical Center

    Los Angeles, California, 90033

    Norah Terrault, norah.terrault@med.usc.edu

    Recruiting

  • University of Miami Health System

    Miami, Florida, 33122

    David Goldberg, dsgoldberg@med.miami.edu

    Recruiting

  • New York Presbyterian/Weill Cornell

    New York, New York, 10021

    Robert Brown, rsb2005@med.cornell.edu

    Recruiting

  • Columbia University Iriving School of Medicine

    New York, New York, 10031

    Elizabeth Verna, ev77@cumc.columbia.edu

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Arun Sanyal, arun.sanyal@vcuhealth.org

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55901

    Doug A. Simonetto, MD, (507) 284-2511, simonetto.douglas@mayo.edu

    Recruiting

  • UCSF/Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California, 94110

    Mandana Khalili, Mandana.Khalili@ucsf.edu

    Recruiting

  • UCSF Medical Center

    San Francisco, California, 94143

    Bilal Hameed, bilal.hameed@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official 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

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.

Read the detailed description

This study is a randomized, double-blind, placebo-controlled Phase 2 clinical trial, of 20mg of rosuvastatin by mouth, once daily. Participants will be randomized (1:1) to either once daily placebo or once daily rosuvastatin.

Patients meeting all eligibility criteria will be assigned to a randomization arm prior to initiation of a 4-week lead-in phase of the study. All participants will undergo a 4-week, open-label active run-in phase to evaluate initial safety and adherence to rosuvastatin. During this active run-phase, all participants will receive target dose rosuvastatin-- 20 mg daily. After the active run-in phase, all participants will continue with their pre-assigned randomization (1:1) treatment of rosuvastatin 20 mg daily or matching placebo.

The total duration of the study will be 96 weeks in the assigned treatment arm plus the 4-week lead-in period. The primary outcome will be the mean change in liver stiffness from the baseline measurement to the end of study liver stiffness, as measured by ultrasound-based vibration-controlled transient elastography (VCTE).

There are 10 participating clinical centers, and we anticipate a total of 260 patients will be recruited for the initial lead-in as we estimate 20% of participants may dropout after the lead-in (260 x 0.8 = 208 for randomization into the study drug treatment phase).

Being tested
Rosuvastatin
Keywords
Cirrhosis, Liver, Nonalcoholic Fatty Liver Disease
Medical subject headings
Fibrosis, Liver Cirrhosis, Liver Cirrhosis, Alcoholic, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosuvastatinDrug

    Also called Rosuvastatin 20 mg

    Patients meeting all eligibility criteria will be assigned to a randomization arm prior to initiation of a 4-week lead-in phase of the study. All participants will undergo a 4-week, open-label active run-in phase to evaluate initial safety and adherence to rosuvastatin. During this active run-phase, all participants will receive target dose rosuvastatin-- 20 mg daily . After the active run-in phase, all participants will continue with their pre-assigned randomization (1:1) treatment of rosuvastatin 20 mg daily or matching placebo.

Study groups in NCT05832229
Study groupRoleWhat they receive
ActiveExperimentalOpen-label lead-in period of 4 weeks on 20 mg rosuvastatin by mouth once daily, followed by a period of 96 weeks rosuvastatin 20 mg daily.
Receives: Drug: Rosuvastatin
PlaceboPlacebo comparatorOpen-label lead-in period of 4 weeks on 20 mg rosuvastatin by mouth once daily, followed by a period of 96 weeks placebo.
Receives: Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in liver stiffness

    Mean change in liver stiffness as measured in kilopascal with Vibration-Controlled Transient Elastography between study entry and week 96. Range: 2 to 75 kilopascal. Higher stiffness indicates increased disease progression

    Measured: 96 weeks

Secondary outcomes (18)

  1. Time to disease progression

    Time to disease progression defined as time to development of decompensation event (ascites, hepatic encephalopathy, variceal bleed) or hepatocellular carcinoma. Analyzed as time-to-event; binary if low counts.

    Measured: 96 weeks

  2. All-cause mortality

    All-cause mortality: time-to-event, binary if low counts

    Measured: 96 weeks

  3. Time to development of ascites

    Ascites: time-to-event, binary if low counts

    Measured: 96 weeks

  4. Time to development of overt hepatic encephalopathy

    Time to development of overt hepatic encephalopathy: time-to-event, binary if low counts

    Measured: 96 weeks

  5. Time to development of variceal bleed

    Variceal bleed: time-to-event, binary if low counts

    Measured: 96 weeks

  6. Time to development of hepatocellular carcinoma

    Hepatocellular carcinoma: time-to-event, binary if low counts

    Measured: 96 weeks

  7. Change in spleen stiffness as measured by Vibration-Controlled Transient Elastography (VCTE)

    Units: kilopascal; Range: 5 to 100 kilopascal; higher stiffness indicates increased disease progression

    Measured: 96 weeks

  8. Change in Child-Turcotte-Pugh score

    Ordinal score from 5 to 15; higher score indicates further disease progression

    Measured: 96 weeks

  9. Change in Model for End Stage Liver Disease - Sodium (MELD-Na)

    Unitless; Range: 6-40; higher score indicates further disease progression

    Measured: 96 weeks

  10. Change in liver stiffness via Magnetic Resonance Elastography

    Units: kilopascal; Range: 0 to 20; higher stiffness indicates increased disease progression

    Measured: 96 weeks

  11. Change in Enhanced Liver Fibrosis test

    Unitless; Range: 5 to 11; Higher score is worse

    Measured: 96 weeks

  12. Change in Fibrosis-4

    Unitless; Range: 0 to 10; higher score indicates more stiffness

    Measured: 96 weeks

  13. Change in patient-reported quality of life scores

    Patient Reported Outcomes Measurement Information System (29-item version) Global Health T-Score: Population centered at 50 points, standard deviation of 10 (higher score signifies "better" health)

    Measured: 96 weeks

  14. Rate of adverse events

    Count

    Measured: 96 weeks

  15. Rate of serious adverse events

    Count

    Measured: 96 weeks

  16. Rate of adverse events of special interest

    Rate of adverse events of special interest (myopathy, drug-induced liver injury, cardiovascular events, cancer other than hepatocellular carcinoma, new onset diabetes as separate outcomes): Count

    Measured: 96 weeks

  17. Time to cardiovascular events

    Cardiovascular events: time-to-event, binary if low counts

    Measured: 96 weeks

  18. Time to new onset diabetes

    New onset diabetes: time-to-event, binary if low counts

    Measured: 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2023
  2. Study start7 Dec 2023
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a randomized, double-blind, placebo-controlled Phase 2 clinical trial, of 20mg of rosuvastatin by mouth, once daily. Participants will be randomized (1:1) to either once daily placebo or once daily rosuvastatin.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05832229
Sponsor's protocol ID
Pro00070580
Other IDs
5U24DK130164-04
Acronym
LCN RESCU
Status last verified
Sep 2026
First submitted
24 Mar 2023
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rosuvastatin in people with Cirrhosis and Cirrhosis, Liver, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 68 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Crystal Santillanes, MS (312-503-5536, lcn@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in liver stiffness (time frame: 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05832229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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