Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Liver Fibroses, Cirrhosis

In brief

Prospective randomized, multi-center, double blind placebo-controlled trial to assess the chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC.

Key facts

Study ID: NCT05028829
Run by: Raymond Chung
People needed: 60
Starts: 2023-05-10
Expected to finish: 2031-03-01
Last updated by the study team: 2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Willing and able to provide informed consent
Male or female age > 18 years at time of consent
Clinically or histologically diagnosed advanced liver fibrosis or cirrhosis, as defined by one or more of the following:
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
High-risk for HCC at screening according to the FIB-4 index
PLSec score ≥ 3 measured in screening blood samples from the FIB-4-high individuals.
Liver imaging within 6 months of Day 1 is required in cirrhotic subjects only, to exclude HCC
Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Willing and able to undergo protocol blood sampling
Subject must be able to comply with dosing instructions for study drug administration and able to complete study schedule of assessments

You may not qualify if…

Diagnosis of any of the following forms of chronic liver disease:
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)
Current or prior history of any of the following:
Clinically significant illness or any other major medical disorder that in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol
Known positivity for HIV infection
Active, untreated HCV infection
Patients with prior history of HCV who achieved sustained virologic response (SVR) >12 from Day 1 may be included in the study
Uncontrolled chronic HBV
Patients with well controlled disease with >12 months of stable medication use (or no medication use, in those persons for whom anti-HBV therapy is not indicated)
Clinical hepatic decompensation, defined as Child's Pugh class >B7 or C cirrhosis
Patients with Child's Pugh score of 7, class B, may be included in the study
History of biliary diversion
Solid organ transplant
Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible
Pregnant or Nursing Females (a negative serum pregnancy test is required at screening for WOCBP)
Life threatening SAE during the screening period
Subjects having the following laboratory parameters at screening
ALT > 10 x ULN
AST > 10 x ULN
Hemoglobin < 8.5 g/dl
Serum creatinine > 2.0 mg/dL
CK > 3x ULN
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
WOCBP must abstain from breastfeeding and be willing to use effective birth control during through the week 4 post treatment follow-up visit

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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