NCT05028829

Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

Multi-center Double Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Long-term Atorvastatin (20 mg/Day) v. Placebo on HCC Risk in Individuals With Advanced Liver Fibrosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Raymond Chung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study objective is to investigate the chemopreventive efficacy of atorvastatin (20 mg) on HCC risk compared to placebo in adults with advanced fibrosis (i.e. METAVIR fibrosis stage 3-4) and high-risk PLSec (defined by pre-randomization blood-based assay). HCC risk will be measured by changes in prognostic liver secretome signature (PLSec) risk score after oral administration of atorvastatin for 1 year with up to 5 years post-treatment of chart monitoring.

Conditions

• Liver Fibroses
• Cirrhosis

Interventions

Type	Name	Description
DRUG	Atorvastatin 20mg	Oral administration of atorvastatin 20 mg
DRUG	Placebo	Oral administration of placebo

Timeline

• Start date: 2023-05-10
• Primary completion: 2026-12-31
• Completion: 2031-03-01
• First posted: 2021-08-31
• Last updated: 2025-09-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study