# Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN)

> **NIH NIH U01** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2024 · $249,733

## Abstract

Project Summary
Metabolic dysfunction associated steatotic liver disease (MASLD), previously referred to as
nonalcoholic fatty liver disease, or NAFLD, affects over 30% of the US population and is a
leading cause of cirrhosis, liver cancer, and need for liver transplantation. The Nonalcoholic
Steatohepatitis Clinical Research Network (NASH CRN), established in 2002, has focused on
characterizing the natural history of the different phenotypes of MASLD, evaluating novel
therapies to treat the condition, and conducting translational studies using a rich repository of
clinical, pathologic, imaging, and -omics data to advance knowledge. Since the last funding
cycle, the NASH CRN adult or pediatric clinical centers have enrolled 1575 participants into a
longitudinal database, including 617 newly enrolled individuals and undertaken two clinical trials:
the Losartan for Pediatric NAFLD (STOP-NAFLD) trial which was terminated early based on
DSMB recommendation and the Vitamin E Dose Ranging Study (VEDS), initiated in 2021,
which is 50% enrolled. During the current funding period, 219,404 total samples (serum,
plasma, liver tissue, DNA and cDNA), including samples for ~1,220 new patients, were added in
the NIDDK Biorepository, and 49,957 samples withdrawn for translational research using the
Ancillary Studies mechanism. The objectives of
the NASH CRN during the final funding period
are (a) to successfully complete the observational longitudinal study of NAFLD in adults and
children (NAFLD Database study, (b) complete the enrollment and follow-up of the VEDS
clinical trial (N=250) and to conduct new translational studies based on the clinical and archived
biospecimens from previous funding These studies may focus on (but not limited to) natural
history of NAFLD and NASH in children and adults, non-invasive assessment of disease
severity (e.g., proteomics, lipodimics, clinical prediction rules) and disease pathogenesis
(cytokine analyses, genome-wide association studies, tissue proteomics). Site-specific studies
include measurement of individual- and neighborhood-level social and structural determinants of
health (SSDOH) including geospatial variables, to determine their influence on MAFLD
development and progression and to evaluate whether the social and structural environment, as
measured by the social deprivation index, modifies the risk of germline genetic variants
(PNPLA3 and others) on disease severity and progression. Collectively, these studies are and
anticipated to address key knowledge gaps in MASLD diagnosis, treatment and prognosis.

## Key facts

- **NIH application ID:** 10983135
- **Project number:** 2U01DK061738-24
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** Norah A. Terrault
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $249,733
- **Award type:** 2
- **Project period:** 2002-06-15 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10983135

## Citation

> US National Institutes of Health, RePORTER application 10983135, Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) (2U01DK061738-24). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10983135. Licensed CC0.

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