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ACE Inhibitor
Lisinopril for Non-Alcoholic Fatty Liver Disease
Phase 2
Recruiting
Led By Mazen Noureddin
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if lisinopril can help prevent the progression of non-alcoholic fatty liver disease, which can lead to liver cancer.
Who is the study for?
Adults diagnosed with nonalcoholic steatohepatitis (NASH) and liver fibrosis, who have not used certain blood pressure medications recently, can join this trial. They must have a stable blood count, kidney function, and be willing to use contraception if of childbearing potential. Exclusions include pregnant or breastfeeding women, those with severe liver disease or recent weight reduction surgery, heavy drinkers, and individuals on unstable doses of certain supplements or diabetes medication.
What is being tested?
The RELIEF-NAFLD study is testing whether the blood pressure medication Lisinopril can prevent worsening of non-alcoholic fatty liver disease (NAFLD) and reduce the risk of developing liver cancer. Participants will undergo various assessments including questionnaires, imaging tests like MRI and ultrasonography for fat in the liver as well as biospecimen collection to monitor effects.
What are the potential side effects?
Lisinopril may cause side effects such as coughing, dizziness due to low blood pressure especially after standing up quickly (orthostatic hypotension), headaches, fatigue and possibly allergic reactions in some people.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in PRO-C3 values
Secondary study objectives
Change in Fibrosis-4 score
Change in inflammatory markers (caspase cleaved cytokeratin 18, NF-kappaB, TGF-beta, TNF-alpha, IL6 and IL8)
Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS)
+1 moreOther study objectives
Change in steatosis
Changes in microbiome and metabolomics and genomics
Side effects data
From 2009 Phase 4 trial • 252 Patients • NCT003918469%
Cardiac Failure
4%
Myocardial Infarction
2%
Anaemia
2%
Chronic Obstructive Pulmonary Disease
2%
Syncope
2%
Ventricular Tachycardia
2%
Angina Pectoris
2%
Artial Fibrillation
2%
Dyspnoea
2%
Hyperkalaemia
2%
Pneumonia
1%
Aortic Stenosis
1%
Cerebral Infarction
1%
Cerebrovascular Accident
1%
Concussion
1%
Confusional State
1%
Diverticulitis
1%
Duodenal Ulcer Haemorrhage
1%
Dyspepsia
1%
Endocarditis
1%
Hepatic Failure
1%
Intestinal Ischaemia
1%
Multi-Organ Failure
1%
Polymyalgia Rheumatica
1%
Right Ventricular Failure
1%
Spinal Fracture
1%
Back Pain
1%
Bladder Neoplasm
1%
Blood Electrolytes Abnormal
1%
Bradycardia
1%
Muscular Weakness
1%
Osteoarthritis
1%
Angina Unstable
1%
B-Cell Lymphoma
1%
Bleeding Varicose Vein
1%
Bronchitis
1%
Carotid Artery Stenosis
1%
Intervertebral Disc Compression
1%
Pulmonary Odema
1%
Respiratory Tract Infection Viral
1%
Septic Shock
1%
Peripheral Ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guided by NT-proBNP
Not Guided by NT-proBNP
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (lisinopril)Experimental Treatment7 Interventions
Patients receive lisinopril PO 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 PDFF MRI and MRE on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 3
~2020
Lisinopril
2012
Completed Phase 4
~39510
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,015 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
1,350 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Mazen NoureddinPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
1 Trials studying Non-alcoholic Fatty Liver Disease
Ju Dong YangPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to drugs that are similar to lisinopril.You have a history of serious liver problems, such as fluid buildup in the abdomen (ascites), confusion caused by liver damage (hepatic encephalopathy), or bleeding from swollen blood vessels in the esophagus (variceal bleeding).You are currently taking lithium medication.You have had liver diseases in the past, like hepatitis or liver damage from alcohol or certain medications.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (lisinopril)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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