Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-12

Study Completion Date

2023-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Nonalcoholic fatty liver disease (NAFLD), defined by fatty infiltration of the liver in the absence of excess alcohol consumption, affects an estimated 30% of adults in the United States. A proportion of people with NAFLD will develop progressive, inflammatory nonalcoholic steatohepatitis (NASH), which can progress to liver cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that among adults with NAFLD, aspirin will reduce intrahepatic lipid content, as quantified by 1H magnetic resonance spectroscopy (1H-MRS).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

NCT06935994

Metabolic Dysfunction Associated Steatotic Liver Disease

RECRUITING PHASE2

Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease

NCT03437720

Non-alcoholic Steatohepatitis Type 2 Diabetes Mellitus

WITHDRAWN PHASE2

Treating Nonalcoholic Steatohepatitis (NASH) With Metformin

NCT00063232

Hepatitis

COMPLETED PHASE2

Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease

NCT02217345

Nonalcoholic Fatty Liver Disease (NAFLD)

COMPLETED PHASE2

The Effect of Acetaminophen on Non-alcoholic Fatty Liver Disease Patients

NCT02194894

Non-alcoholic Fatty Liver Disease (NAFLD)

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aspirin

Low-dose (81mg) aspirin tablets

Group Type EXPERIMENTAL

Aspirin 81 mg

Intervention Type DRUG

Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.

Placebo

Placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aspirin 81 mg

Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.

Intervention Type DRUG

Placebo oral tablet

Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ages 18 to 70 years
* NAFLD, defined by confirmed hepatic steatosis by imaging or by liver biopsy, in the absence of other causes of hepatic steatosis or significant alcohol consumption. If liver imaging or biopsy has not been performed clinically, liver ultrasound assessment will be performed as part of the screening visit.
* Early-stage liver fibrosis, defined as fibrosis less than or equal to Fibrosis Stage 3 (F3), confirmed by either (1) a recent liver biopsy or (2) a recent elastography / Fibroscan study. If no recent biopsy or elastography/Fibroscan have been performed, a Fibroscan will be performed as part of the screening visit.

Exclusion Criteria

* Liver fibrosis stage \> 3
* Current aspirin use
* Contraindications to aspirin use
* Contraindications to magnetic resonance imaging (MRI)
* Pregnancy or desire to become pregnant
* Breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No