NCT04550481

Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study

Role of Lisinopril in Preventing The Progression of Non-Alcoholic Fatty Liver Disease (NAFLD): Relief-NAFLD

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial investigates how well lisinopril may work in preventing the progression of non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where there is an accumulation of fatty cells in the liver. NAFLD increases a person's risk of developing liver cancer. Liver fibrosis is the common finding of chronic liver diseases leading to reduced liver function. Lisinopril is a medication that is commonly used to treat high blood pressure. Lisinopril may help to decrease liver fibrosis. The purpose of this trial is to find out what effect, if any, lisinopril has on a patient's risk of developing liver cancer.

Detailed description

PRIMARY OBJECTIVE: I. To determine if NAFLD patients with advanced fibrosis will demonstrate a change in PRO-C3, a marker of liver fibrosis, following 24 weeks of treatment with lisinopril. SECONDARY OBJECTIVES: I. Noninvasive measures of fibrosis and steatosis: Ia. Change from baseline in PC3X (cross-linked multimeric PRO-C3); Ib. Change from baseline in steatosis, as measured by controlled attenuation parameter (CAP) or liver ultra-sound attenuation (LiSA), determined with transient elastography: Ic. Change from baseline in liver stiffness as measured with magnetic resonance elastography (MRE); Id. Change from baseline in liver stiffness as measured with transient elastography; Ie. Changes from baseline in Fibrosis-4 score (FIB-4) and NAFLD fibrosis score (NFS); If. Change in inflammatory markers (caspase cleaved cytokeratin 18 \[CK-18\], NF-kappaB, TGF-beta, TNF-alpha, IL6 and IL8). OUTLINE: Patients receive lisinopril orally (PO) once daily (QD) for 24 weeks in absence of unacceptable toxicity. Patients undergo transient elastography during screening and on study. Patients also undergo blood sample collection on study and may undergo a proton density fat fraction (PDFF) magnetic resonance imaging (MRI) and MRE on study. Patients are followed up at 32 weeks after the start of study medication.

Conditions

• Hepatocellular Carcinoma
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DRUG	Lisinopril	Given PO
PROCEDURE	Liver Ultrasonographic Elastography	Undergo transient elastography
PROCEDURE	Magnetic Resonance Elastography	Undergo PDFF MRE
PROCEDURE	Magnetic Resonance Imaging	Undergo PDFF MRI
PROCEDURE	Proton Density Fat Fraction	Undergo PDFF MRI/MRE
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2021-05-11
• Primary completion: 2025-08-08
• Completion: 2026-09-30
• First posted: 2020-09-16
• Last updated: 2026-01-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study