Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

NCT04031729 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 2019P001809
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis

Keywords

Aspirin; Liver Disease; Anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• Absolute Change in Intrahepatic Lipid Content, by 1H-MRS

  Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS

  6 months

Secondary Outcomes (1)

• Relative Change in Intrahepatic Lipid Content

  6 months

Study Arms (2)

Aspirin

EXPERIMENTAL

Low-dose (81mg) aspirin tablets

Drug: Aspirin 81 mg

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo oral tablet

Interventions

Aspirin 81 mg DRUG

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

Aspirin

Placebo oral tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Simon TG, Wilechansky RM, Stoyanova S, Grossman A, Dichtel LE, Lauer GM, Miller KK, Hoshida Y, Corey KE, Loomba R, Chung RT, Chan AT. Aspirin for Metabolic Dysfunction-Associated Steatotic Liver Disease Without Cirrhosis: A Randomized Clinical Trial. JAMA. 2024 Mar 19;331(11):920-929. doi: 10.1001/jama.2024.1215.

  PMID: 38502074 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Tracey Simon
• Organization: Massachusetts General Hospital

tgsimon@partners.org

617-724-2401

Study Officials

• Tracey G Simon, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine and Gastroenterology

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: September 12, 2019
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)