Hepatocellular CarcinomaPhase 2NCT04550481
Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study
A Phase 2 study testing Biospecimen Collection, Lisinopril and Liver Ultrasonographic Elastography in people with Hepatocellular Carcinoma and Nonalcoholic Steatohepatitis, run by Northwestern University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Nonalcoholic Steatohepatitis
- What is being tested?
- Biospecimen Collection, Lisinopril and Liver Ultrasonographic Elastography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 May 2021to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects >= 18 years of age
- Clinical diagnosis of nonalcoholic steatohepatitis (NASH) assessed by the presence of body imaging criteria (ultrasound, computed tomography [CT], or magnetic resonance imaging [MRI]), or liver biopsy up to six months prior to enrollment without suspicious nodules or cancer
- Screening transient elastography liver stiffness >= 12 kPa (which correlates with F3 fibrosis and more) and < 25 kPa. Historic transient elastography within 0-4 weeks prior to the date of the screening visit is acceptable. Patients with liver stiffness >= 10 and < 12 kPA with clinical evidence of cirrhosis based on any of the following criteria would also be eligible.
- Imaging diagnosis of nodular liver with splenomegaly or recanalized umbilical vein
- MRE >= 5 kPa
- Fibrosis (FIB)-4 > 2.67 or platelet count < 150,000 mL
Show all 19Show fewer
- Liver biopsy < 5 years with meta-analysis of histological data in viral hepatitis (METAVIR) stage 4 or Ishak stage 5-6
- Controlled attenuation parameter score or liver steatosis analysis (LiSA) of >= 260 dB/m and any single component of metabolic syndrome (ATP3 criteria) or historic liver biopsy within 0 - 6 months prior to the date of the screening visit consistent with nonalcoholic steatohepatitis (NASH) (defined as the presence of steatosis, inflammation, and ballooning), with stage 3-4 fibrosis according to the NASH Clinical Research Network classification (or equivalent)
- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
- Platelets >= 75,000/microliter
- Total bilirubin within normal institutional limits unless the patient has Gilbert's syndrome
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 8 x institutional upper limit of institutional limits
- Glomerular filtration rate > 30 ml/min
- International normalized ratio (INR) =< 1.3 unless the patient is on a therapeutic medication
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- The effects of lisinopril has been shown to be teratogenic in animal models. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document. If a participant has impaired decision-making capacity (IDMC), their legal representative may replace them in this process
- Systolic blood pressure >= 90 and =< 160 mm/Hg. Diastolic blood pressure >= 60 and =< 110 mm/Hg
Who cannot join
- Prior or current use of an angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor antagonist (ARB) within 0-24 weeks prior to enrollment
- Glomerular filtration rate =< 30 ml/min (for both male and female participants)
- History of decompensated liver disease, including ascites, hepatic encephalopathy, or high-risk variceal bleeding
- NOTE: Trace ascites documented by radiology is permitted
- History of other causes of liver disease, including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (primary biliary cholangitis, primary sclerosing cholangitis, or autoimmune hepatitis), drug-induced hepatotoxicity, Wilson's disease, iron overload, or alpha-1-antitryspin deficiency
- History of liver transplantation
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- History of hepatocellular carcinoma (HCC) diagnosis
- History of weight reduction surgery in the past 2 years or planned during the study
- Within 6 months prior to the date of the screening visit, there must be no history of the following cardiac events: unstable angina; myocardial infarction, coronary artery bypass surgery or coronary angioplasty; transient ischemic attack or cerebrovascular accident; emergency room visit or hospitalization for confirmed cardiovascular disease
- Participants taking vitamin E >= 800 IU/day must be on a stable dose, defined as no changes in prescribed dose, new vitamin E-containing medications, or discontinuation for at least 180 days prior to the date of the screening visit and throughout study participation
- Participants taking anti-diabetic medications must be on a stable dose for at least 90 days prior to the date of the screening visit and in the period between the date of the screening visit and enrollment
- Current alcohol consumption > 21 oz/week for males or > 14 oz/week for females (1 oz/30 mL of alcohol is present in one 12 oz/360 mL beer, 4 oz/120 mL glass of wine, and a 1oz/30 mL measure of 40 proof [20%] alcohol)
- Participants may not be receiving any other investigational agents, at the time of the screening visit, or in the prior 30 days, or within 5 half-lives of the prior investigational agent (whichever is longer)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lisinopril
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
- History of human immunodeficiency virus (HIV) infection. HIV patients may develop fatty liver as well as advanced fibrosis due to many causes including metabolic syndrome, hyperuricemia, HIV-related lipodystrophy, genetic polymorphisms, medications, and HIV itself. As the natural history of fatty liver in this population is largely unknown, these patients will be excluded from this study
- Women who are pregnant or breastfeeding. Pregnant women are excluded from this study because lisinopril is an ACE Inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with lisinopril. Breastfeeding should be discontinued if the mother is treated with lisinopril
- Systolic blood pressure >= 161 mm/Hg. Diastolic blood pressure >= 111 mm/Hg
- Participants taking lithium
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University Medical Center
Durham, North Carolina, 27710
Cedars Sinai Medical Center
Los Angeles, California, 90048
Mount Sinai Hospital
New York, New York, 10029
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Role of Lisinopril in Preventing The Progression of Non-Alcoholic Fatty Liver Disease (NAFLD): Relief-NAFLD
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- Biospecimen Collection, Lisinopril, Liver Ultrasonographic Elastography, Magnetic Resonance Elastography, Magnetic Resonance Imaging
- Medical subject headings
- Carcinoma, Hepatocellular, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
LisinoprilDrug
Also called N2-[(1S)-1-Carboxy-3-phenylpropyl]-L-lysyl-L-proline, Dihydrate, Prinivil, Zestril
Given PO
Liver Ultrasonographic ElastographyProcedure or surgery
Also called Fibroscan, TE, Transient Elastography, VCTE
Undergo transient elastography
Magnetic Resonance ElastographyProcedure or surgery
Also called MRE
Undergo PDFF MRE
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo PDFF MRI
Proton Density Fat FractionProcedure or surgery
Also called Fat Fraction by Proton Density, PDFF
Undergo PDFF MRI/MRE
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Prevention (lisinopril) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Drug: Lisinopril; Procedure: Liver Ultrasonographic Elastography; Procedure: Magnetic Resonance Elastography; Procedure: Magnetic Resonance Imaging; Procedure: Proton Density Fat Fraction; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PRO-C3 Values
Descriptive statistics will be used to summarize changes and values at each time point. The primary analysis will be performed using a paired t-test to compare the pre- to post-treatment changes in PRO-C3 levels. PRO-C3 levels will be log-transformed to satisfy the normality assumption. If log-transformation does not satisfy the normality assumption, a signed rank test will be used.
Measured: Baseline to 24 weeks
Secondary outcomes (7)
Change in PRO-C6 Value.
Descriptive statistics will be used to summarize changes and values at each time point. The primary analysis will be performed using a paired t-test to compare the pre- to post-treatment changes in PRO-C6 levels. PRO-C6 levels will be log-transformed to satisfy the normality assumption. If log-transformation does not satisfy the normality assumption, a signed rank test will be used.
Measured: Baseline to 24 weeks
Change in Steatosis, Controlled Attenuation Parameter (CAP)
Measured by CAP, determined with transient elastography. Changes in categorical variables will be analyzed using the Stuart-Maxwell test of marginal homogeneity. Linear regression models will be used to identify baseline characteristics that are associated with biomarker changes. Model selection will be conducted according to the purposeful model selection approach (REF) to a parsimonious set of predictors. Model fit will be assessed using standard regression diagnostics. Changes in categorical outcomes from pre- to post-treatment will also be categorized as improvement vs. no improvement (i.e. no change or worsening in steatosis grade), and logistic regression models will be used to examine association with baseline characteristics.
Measured: Baseline to 24 weeks
Change Liver Stiffness, Magnetic Resonance Elastography.
Measured with magnetic resonance elastography. Changes in categorical variables will be analyzed using the Stuart-Maxwell test of marginal homogeneity. Linear regression models will be used to identify baseline that are associated with biomarker changes. Model selection will be conducted according to the purposeful model selection approach (REF) to a parsimonious set of predictors. Model fit will be assessed using standard regression diagnostics. Changes in categorical outcomes from pre- to post-treatment will also be categorized as improvement vs. no improvement (i.e. no change or worsening in steatosis grade), and logistic regression models will be used to examine association with baseline characteristics.
Measured: Baseline to 24 weeks
Change Liver Stiffness, Transient Elastography
Measured with transient elastography. Changes in categorical variables will be analyzed using the Stuart-Maxwell test of marginal homogeneity. Linear regression models will be used to identify baseline characteristics that are associated with biomarker changes. Model selection will be conducted according to the purposeful model selection approach (REF) to a parsimonious set of predictors. Model fit will be assessed using standard regression diagnostics. Changes in categorical outcomes from pre- to post-treatment will also be categorized as improvement vs. no improvement (i.e. no change or worsening in steatosis grade), and logistic regression models will be used to examine association with baseline characteristics.
Measured: Baseline to 24 weeks
Change in Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS)
Changes in categorical variables will be analyzed using the Stuart-Maxwell test of marginal homogeneity. Linear regression models will be used to identify baseline characteristics that are associated with biomarker changes. Model selection will be conducted according to the purposeful model selection approach (REF) to a parsimonious set of predictors. Model fit will be assessed using standard regression diagnostics. Changes in categorical outcomes from pre- to post-treatment will also be categorized as improvement vs. no improvement (i.e. no change or worsening in steatosis grade), and logistic regression models will be used to examine association with baseline characteristics. Scores fall into three ranges: < -1.455 (Low Risk for F0-F2), -1.455 to 0.675 (Indeterminate), and > 0.675 (High Risk for F3-F4).
Measured: Baseline to 24 weeks
Change in Fibrosis-4 Score
Changes in categorical variables will be analyzed using the Stuart-Maxwell test of marginal homogeneity. Linear regression models will be used to identify baseline characteristics that are associated with biomarker changes. Model selection will be conducted according to the purposeful model selection approach (REF) to a parsimonious set of predictors. Model fit will be assessed using standard regression diagnostics. Changes in categorical outcomes from pre- to post-treatment will also be categorized as improvement vs. no improvement (i.e. no change or worsening in steatosis grade), and logistic regression models will be used to examine association with baseline characteristics. < 1.30: Low likelihood of significant liver fibrosis. 1.30 - 2.67: Indeterminate or intermediate risk. > 2.67: High likelihood of advanced fibrosis.
Measured: Baseline to 24 weeks
Change in Inflammatory Markers (TGF-beta, TNF-alpha, IL-6 and IL-8)
Descriptive statistics, including means, 95% confidence intervals, or median and inter-quartile range, will be used to summarize changes as well as biomarker values at each time point. To determine whether changes in these biomarkers occurred following treatment, paired t-test will be used as described for the analysis of the primary endpoint. Biomarker values may be transformed to satisfy the normality assumption. If no suitable transformation can be found, a signed rank test will be used. For the analysis of inflammatory biomarkers, tests will be adjusted for multiple comparisons to control the false discovery rate using the method of Romano.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start11 May 2021
- Primary completion8 Aug 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ju Dong Yang, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550481
- Sponsor's protocol ID
- NCI-2020-06905
- Other IDs
- NCI-2020-06905, NCI20-01-03, NWU20-01-03, P30CA060553, UG1CA242643
- Status last verified
- Jan 2026
- First submitted
- 15 Sep 2020
- Last updated
- 14 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lisinopril in Preventing The Progression of Non-Alcoholic Fatty Liver Disease (NAFLD): Relief-NAFLD
- ClinicalTrials.gov ID
- NCT04550481
- Acronym / sponsor ID
- NCI-2020-06905
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2021 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 14 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (lisinopril) | Experimental | Procedure: Biospecimen Collection, Drug: Lisinopril, Procedure: Liver Ultrasonographic Elastography, Procedure: Magnetic Resonance Elastography, Procedure: Magnetic Resonance Imaging, Procedure: Proton Density Fat Fraction, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male and female subjects >= 18 years of age
- Clinical diagnosis of nonalcoholic steatohepatitis (NASH) assessed by the presence of body imaging criteria (ultrasound, computed tomography [CT], or magnetic resonance imaging [MRI]), or liver biopsy up to six months prior to enrollment without suspicious nodules or cancer
- Screening transient elastography liver stiffness >= 12 kPa (which correlates with F3 fibrosis and more) and < 25 kPa. Historic transient elastography within 0-4 weeks prior to the date of the screening visit is acceptable. Patients with liver stiffness >= 10 and < 12 kPA with clinical evidence of cirrhosis based on any of the following criteria would also be eligible.
- Controlled attenuation parameter score or liver steatosis analysis (LiSA) of >= 260 dB/m and any single component of metabolic syndrome (ATP3 criteria) or historic liver biopsy within 0 - 6 months prior to the date of the screening visit consistent with nonalcoholic steatohepatitis (NASH) (defined as the presence of steatosis, inflammation, and ballooning), with stage 3-4 fibrosis according to the NASH Clinical Research Network classification (or equivalent)
- Leukocytes >= 3,000/microliter
Key exclusion criteria (19 listed)
- Prior or current use of an angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor antagonist (ARB) within 0-24 weeks prior to enrollment
- Glomerular filtration rate =< 30 ml/min (for both male and female participants)
- History of decompensated liver disease, including ascites, hepatic encephalopathy, or high-risk variceal bleeding
- History of other causes of liver disease, including but not limited to alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (primary biliary cholangitis, primary sclerosing cholangitis, or autoimmune hepatitis), drug-induced hepatotoxicity, Wilson's disease, iron overload, or alpha-1-antitryspin deficiency
- History of liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Prevention (lisinopril) |
| LisinoprilAlso: N2-[(1S)-1-Carboxy-3-phenylpropyl]-L-lysyl-L-proline, Dihydrate, Prinivil, ZestrilGiven PO | Drug | Prevention (lisinopril) |
| Liver Ultrasonographic ElastographyAlso: Fibroscan, TE, Transient Elastography, VCTEUndergo transient elastography | Procedure or surgery | Prevention (lisinopril) |
| Magnetic Resonance ElastographyAlso: MREUndergo PDFF MRE | Procedure or surgery | Prevention (lisinopril) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo PDFF MRI | Procedure or surgery | Prevention (lisinopril) |
| Proton Density Fat FractionAlso: Fat Fraction by Proton Density, PDFFUndergo PDFF MRI/MRE | Procedure or surgery | Prevention (lisinopril) |
| Questionnaire AdministrationAncillary studies | Other | Prevention (lisinopril) |
Primary outcome
Change in PRO-C3 Values
Time frame: Baseline to 24 weeks
Descriptive statistics will be used to summarize changes and values at each time point. The primary analysis will be performed using a paired t-test to compare the pre- to post-treatment changes in PRO-C3 levels. PRO-C3 levels will be log-transformed to satisfy the normality assumption. If log-transformation does not satisfy the normality assumption, a signed rank test will be used.
7 secondary outcomes
Change in PRO-C6 Value.
Time frame: Baseline to 24 weeks
Change in Steatosis, Controlled Attenuation Parameter (CAP)
Time frame: Baseline to 24 weeks
Change Liver Stiffness, Magnetic Resonance Elastography.
Time frame: Baseline to 24 weeks
Change Liver Stiffness, Transient Elastography
Time frame: Baseline to 24 weeks
Change in Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS)
Time frame: Baseline to 24 weeks
Change in Fibrosis-4 Score
Time frame: Baseline to 24 weeks
Change in Inflammatory Markers (TGF-beta, TNF-alpha, IL-6 and IL-8)
Time frame: Baseline to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju Dong Yang principal investigator
Northwestern University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Lisinopril and Liver Ultrasonographic Elastography in people with Hepatocellular Carcinoma and Nonalcoholic Steatohepatitis, run by Northwestern University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PRO-C3 Values (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.