# Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN)

> **NIH NIH U01** · VIRGINIA COMMONWEALTH UNIVERSITY · 2024 · $249,999

## Abstract

This proposal, in response to RFA-18-505, is an application for the fourth competitive renewal of the VCU-Emory
clinical centers of the NIDDK NASH Clinical Research Network (CRN). It has three specific aims that are aligned
with the planned objectives of the renewal of the NASH CRN. Specific aim 1 is to complete recruitment and
retain adult and pediatric subjects in the NAFLD Database 3 (DB3) study to support execution, analysis and
publication of data to address unmet needs in the field. We will continue enrollment and follow up of participants
in the NAFLD Database 3 (DB3) cohort study with collection of bio-samples and clinical data according to the
protocol and leverage this data-set to obtain novel insights in to disease biology and validate biomarkers
including measurements of spleen stiffness in this population. We already have met our recruitment target and
will over-enroll in this study where we have over 90% retention. Specific aim 2 is to fully enroll and complete
the ongoing vitamin E dose ranging study of metabolic dysfunction-associated steatotic liver disease (MASLD),
previously known as nonalcoholic fatty liver disease (NAFLD). We are close to completing recruitment and
expect to meet our enrollment goals by the end of the current funding cycle and have 100% retention in the
study. Specific aim 3 is to leverage the transcriptomic dataset generated as part of the NASH CRN ancillary
study linked to the CRN database-2 study to validate molecular subclasses of MASLD and their relationship to
disease course and outcomes. It builds on our previously published findings that there are distinct transcriptomic
profiles within patients with similar histological severity of MASH. Specifically, we will generate novel data on
their relationship to histological progression of disease and in those with advanced fibrosis, relate them to time
to decompensation and clinical outcomes. A key focus will be to evaluate metabo-inflammation, accelerated
aging and fibrogenesis related pathways to disease progression and outcomes. The proposed studies will be
highly significant and impact the field as follows: (1) improved understanding of disease evolution including bi-
directional interactions in liver and other metabolic dysfunction associated end-organ disease and impact of
social and economic determinants of health, (2) acceleration of regulatory qualification of non-invasive tests for
clinical use via collaboration with the FNIH NIMBLE project, (3) validation of spleen stiffness measurements and
development of other biomarkers, (4) novel insights on disease heterogeneity via the proposed transcriptomic
studies and (5) generating foundational data to support future applications for a fully powered trial of vitamin E
for metabolic dysfunction associated steatohepatitis (MASH). The VCU and Emory clinical centers have played
a robust role in advancing the mission of the NASH CRN and are fully committed to the proposed requirements
of the RFA and have the ...

## Key facts

- **NIH application ID:** 10981563
- **Project number:** 2U01DK061731-23
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** ARUN J SANYAL
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $249,999
- **Award type:** 2
- **Project period:** 2002-05-20 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10981563

## Citation

> US National Institutes of Health, RePORTER application 10981563, Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) (2U01DK061731-23). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10981563. Licensed CC0.

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