# S-adenosylmethionine treatment in alcoholic cirrhosis

> **NIH NIH U01** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $273,786

## Abstract

Project Summary
Alcoholic cirrhosis is a leading cause of morbidity and mortality in the US. One of the key drivers in its
pathogenesis is the reduction in hepatic methionine adenosyltransferase 1A (MAT1A) expression resulting in
the reduction in hepatic S-adenosylmethionine (SAMe) levels. The reduction in SAMe level leads to several
adverse intracellular consequences, which include promoting the inflammatory cascades in immune cells such
as macrophages by lipopolysaccharides (LPS), oxidative stress and endoplasmic reticulum (ER) stress. This
project involves two academic centers in the United States (Cedars-Sinai Medical Center in Los Angeles and
Indiana University Hospital), a research institute in Spain (CIC bioGUNE), and NIAAA intramural liver research
scientist (Dr. Bin Gao) to examine SAMe in humans with alcoholic cirrhosis. We proposed a randomized
double-blind placebo controlled trial to determine the efficacy of SAMe (1,200 mg/day given in two divided
dose) and its mechanistic effects in patients with alcoholic cirrhosis (Child class A and B) in the real world
setting. The primary endpoint will be the mortality of any causes between groups. The target enrollment of our
clinical trial is 196 participants (176 patients with alcohol-associated cirrhosis and 20 controls). The approval
for funding of our study started on September 20, 2019. However, our study was significantly impacted by the
COVID-19 pandemic in 2020 and 2021. The administrative hold on research activities due to the pandemic
prohibited us to enroll patients as we anticipated. To date, 112 participants (~57%) were enrolled. Our
enrollment continues to improve and meet the monthly target enrollment starting around the beginning of Yr 3
of the project (~September 2021, the time when the overall COVID-19 pandemic was improving). Given the
trajectory of the enrollment, we anticipated that we should be able to complete our enrollment around August
2026. Our current funding ends on 8/31/24. This supplemental application is to allow us to complete the
clinical trial, currently being funded by 1U01AA02681.

## Key facts

- **NIH application ID:** 11097467
- **Project number:** 3U01AA026817-05S1
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Bin Gao
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $273,786
- **Award type:** 3
- **Project period:** 2024-06-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11097467

## Citation

> US National Institutes of Health, RePORTER application 11097467, S-adenosylmethionine treatment in alcoholic cirrhosis (3U01AA026817-05S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11097467. Licensed CC0.

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