Could a $10 cholesterol pill prevent liver cancer?
NCT ID NCT05028829
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether taking atorvastatin (Lipitor) daily for 48 weeks can reduce the risk of liver cancer in 60 adults with advanced liver fibrosis or cirrhosis. Participants are randomly assigned to receive either the drug or a placebo. The main goal is to see if atorvastatin lowers a blood-based risk score for liver cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atorvastatin (Lipitor)
- What this could lead to
- If it works, this could show that a common cholesterol drug helps prevent liver cancer in people with advanced liver scarring.
- What could go wrong
- This is a small, early-phase trial (60 people) testing a biomarker, not cancer itself. The drug may not reduce actual cancer risk, and side effects like muscle pain or liver issues are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing and able to provide informed consent 2. Male or female age \> 18 years at time of consent 3. 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 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 Criteria: 1. 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) 2. 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 3. Known positivity for HIV infection 4. 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 5. 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) 6. 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 7. History of biliary diversion 8. Solid organ transplant 9. 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 10. Pregnant or Nursing Females (a negative serum pregnancy test is required at screening for WOCBP) 11. Life threatening SAE during the screening period 12. 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 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 \- Subjects who are on a current statin at time of consent must be willing to undergo a 90-day washout period prior to randomization 18. Known hypersensitivity to atorvastatin 19. Current or planned participation in an investigational new drug (IND) trial from 30-days prior to randomization through the week 4 post treatment follow-up visit
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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University of Texas Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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