Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

• ClinicalTrials.gov Identifier: NCT04031729
• Recruitment Status: Completed
• First Posted: July 24, 2019
• Last Update Posted: August 14, 2023
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Tracey G. Simon, MD, Massachusetts General Hospital

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis	Drug: Aspirin 81 mg; Drug: Placebo oral tablet	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Aspirin in Adults With Nonalcoholic Fatty Liver Disease
• Actual Study Start Date: September 12, 2019
• Actual Primary Completion Date: February 23, 2023
• Actual Study Completion Date: February 23, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aspirin; Low-dose (81mg) aspirin tablets	Drug: Aspirin 81 mg; Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.
Placebo Comparator: Placebo; Placebo tablets	Drug: Placebo oral tablet; Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.

Outcome Measures

Primary Outcome Measures :

1. Percent intrahepatic lipid content, quantified by 1H-MRS [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Concentrations of circulating bioactive lipid mediators [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: Tracey G Simon, MD, MPH; Massachusetts General Hospital

More Information

• Responsible Party: Tracey G. Simon, MD, Instructor in Medicine and Gastroenterology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04031729
• Other Study ID Numbers: 2019P001809
• First Posted: July 24, 2019
• Last Update Posted: August 14, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tracey G. Simon, MD, Massachusetts General Hospital:

Aspirin; Liver Disease; Anti-inflammatory

Additional relevant MeSH terms:

Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Aspirin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics