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Atorvastatin for Liver Fibrosis and Cirrhosis

This study is looking at whether atorvastatin (a common cholesterol-lowering drug) can help reduce the risk of liver cancer (HCC) in adults with advanced liver fibrosis or cirrhosis. You might be able to join if you are over 18 and have advanced liver fibrosis or cirrhosis, confirmed by a liver biopsy or other tests like Fibroscan. The study will compare atorvastatin 20mg to a placebo (an inactive pill) to see if atorvastatin can reduce a specific high-risk marker in your blood called PLSec. The main goal is to see if this marker is reduced after 48 weeks of treatment. The current status of this study is unclear, and it plans to enroll up to 60 participants.

Study design
This is a randomized, multi-center, double-blind study, meaning participants will be randomly assigned to receive either atorvastatin or a placebo, and neither you nor your doctor will know which you are receiving. It plans to include up to 60 adults.
What's involved
You would take either atorvastatin 20mg or a placebo by mouth. The primary endpoint is measured at 48 weeks, but the study involves up to 1 year of treatment.
Compensation
Not stated in the trial record.
Follow-up
After treatment, your medical charts will be monitored for up to 5 years.

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NCT05028829

Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

Recruiting
PHASE2Ages 18+InterventionalPrevention
Raymond Chung
~60 participants
Updated 2025-09-23 on ClinicalTrials.gov
What's tested:Atorvastatin 20mgPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Reduced magnitude of high-risk PLSec after treatment vs before treatment
Measured over 48 weeks

Conditions

Liver Fibroses
Cirrhosis

Explore related trials

CirrhosisLiver FibrosisPLEC Gene

Where it's being run

2 sites across 2 states
Massachusetts1
Texas1

Study leadership

  • Raymond Chung, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Raymond Chung, MD
[email protected]
617-724-7526
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Liver biopsy demonstrating advanced fibrosis or cirrhosis (METAVIR 3-4)
Fibroscan or MR elastography consistent with advanced fibrosis or cirrhosis
Imaging showing cirrhotic-appearing liver with signs of portal hypertension
Advanced fibrosis or cirrhosis documented clinically by a treating physician 4. High-risk for HCC at screening according to the FIB-4 index 5. PLSec score ≥ 3 measured in screening blood samples from the FIB-4-high individuals. 6. Liver imaging within 6 months of Day 1 is required in cirrhotic subjects only, to exclude HCC 7. Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 8. Willing and able to undergo protocol blood sampling 9. Subject must be able to comply with dosing instructions for study drug administration and able to complete study schedule of assessments

Exclusion

alpha-1-antitrypsin (A1AT) deficiency, Wilson disease, hemochromatosis, iron overload, prior known or suspected drug-induced liver injury (DILI)
Patients with PBC, PSC, AIH, or stable hemochromatosis may be included if their liver disease etiology overlaps with that of steatotic liver disease (SLD) 2. Current or prior history of any of the following:
ALT \> 10 x ULN
AST \> 10 x ULN
Hemoglobin \< 8.5 g/dl
Serum creatinine \> 2.0 mg/dL
CK \> 3x ULN 13. Females who may wish to become pregnant and/or plan to undergo egg harvesting during the study and up to 30 days of the last dose of study drug 14. WOCBP must abstain from breastfeeding and be willing to use effective birth control during through the week 4 post treatment follow-up visit 15. Clinically relevant alcohol or drug abuse within 12 months of screening 16. Use of any prohibited concomitant medications as described in Section 9.1.1 17. Use of a statin medication within 90 days of Day 1 visit

What this trial measures

  • Reduced magnitude of high-risk PLSec after treatment vs before treatment48 weeks

    The primary objective (primary endpoint) of this study is to determine the effect of atorvastatin compared with placebo on HCC risk level measured by change in serum-based prognostic liver secretome signature (PLSec) score (delta-PLSec). High-risk for HCC is indicated by a PLSec score of 3 or greater. Low-risk for HCC is indicated by a PLSec score below 3.