# Clinical Research on Nonalcoholic Fatty Liver Disease

> **NIH NIH U01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2024 · $250,000

## Abstract

PROJECT SUMMARY
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly termed nonalcoholic fatty liver
disease (NAFLD), affects approximately 25% of adults and 10% of children in the United States. Multi-factorial
in its pathogenesis, the clinical/histologic spectrum of MASLD encompasses steatosis, metabolic dysfunction-
associated steatohepatitis (MASH), variable degrees of fibrosis, and cirrhosis. The presence of MASH or
advanced fibrosis due to MASLD are associated with increased risks of hepatic decompensation, hepatocellular
carcinoma (HCC), and death. There are currently no FDA-approved therapies for treatment of MASH. The sheer
scale of the affected population creates an urgent need for effective treatments as well as non-invasive modalities
and biomarkers that alone or in combination accurately 1) predict who is at high risk for disease progression in
the MASLD population, 2) detect and stage MASLD, MASH, and liver fibrosis, 3) predict treatment response, as
determined by ≥ 1-stage improvement in fibrosis or MASH resolution.
Since its inception in 2002, the NASH CRN has worked collaboratively to characterize the natural history of
MASLD, define its pathogenesis, and develop superior diagnostics and effective treatments. During the past
funding cycle (2018-23), the CRN completed recruitment for the longitudinal adult and pediatric Database 2
registry (N=3,068) and the STOP-NAFLD trial (N=83). In addition, it initiated two studies: 1) Database 3, a
longitudinal study of the etiology, natural history, diagnosis, treatment and prevention of MASLD and MASH with
a goal of recruiting a diverse cohort, and 2) the Vitamin E Dosing Study (VEDS), a clinical trial with the primary
aim of determining the minimum effective dose of Vitamin E for MASH.
The NASH CRN’s highly characterized cohorts, including more than 700,000 biospecimens in the NIDDK
repository, together with the investigator’s expertise in leveraging public-private partnerships, has allowed us to
perform innovative clinical trials and pursuits in diagnostic development and validation that can only be
addressed by engaging in a coordinated, longitudinal, comprehensive research consortium. The overriding
primary objective of the NASH CRN continues to be clinical research on MASLD in children and adults. A
secondary objective of high priority is to conduct translational research in MASH and MASLD and to develop
superior diagnostics and treatments, with a focus on diagnostics that are non-invasive and treatments that are
safe, affordable, effective and readily available.
The specific aims proposed to achieve these objectives from the UCSD Clinical Center during the continuation
of the NASH CRN are to 1) complete the Database 3 Study, 2) complete the VEDS Study, and 3) validate and
advance development of novel non-invasive biomarkers for MASH, at-risk MASH, and advanced fibrosis or
cirrhosis.

## Key facts

- **NIH application ID:** 10980113
- **Project number:** 2U01DK061734-24
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** ROHIT LOOMBA
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $250,000
- **Award type:** 2
- **Project period:** 2002-09-15 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10980113

## Citation

> US National Institutes of Health, RePORTER application 10980113, Clinical Research on Nonalcoholic Fatty Liver Disease (2U01DK061734-24). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10980113. Licensed CC0.

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