# Amino Acids and Pediatric Hepatic Steatosis

> **NIH NIH R44** · AMINO COMPANY LLC, THE · 2023 · $883,007

## Abstract

7. Project Summary/Abstract
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in North America (1). Hepatic
steatosis (HS) is the hallmark of NAFLD (2). NAFLD may transition in sub-groups to chronic inflammation (non-
alcoholic steatohepatitis, NASH), and ultimately to cirrhosis. HS is prevalent in all stages of NAFLD. 3-10% of
all children in the US and 40-70% of obese children have HS (3). There are approximately 15 million obese
children in the US (4), meaning that as many as 10 million youths have HS. Pediatric HS is associated with
premature mortality due to type 2 diabetes (T2D), cardiovascular disease (CVD) and progressive liver disease
in early adulthood (5,6). Successful treatment of pediatric HS is therefore central to long-term metabolic and
cardiovascular health. Recommended options are largely limited to behavioral modifications (i.e., weight loss
and exercise) and nutritional supplement with Vitamin E (3,5-7). There is no FDA-approved drug for the
treatment of NAFLD in individuals of any age.
 We propose to perform a randomized clinical trial (RCT) in youths with HS. We will expand our previous
study in which treatment with our essential amino acid (EAA)-based composition called AMS2392 reduced liver
fat in adolescent females with polycystic ovary syndrome (PCOS).
Specific Aim 1. We will investigate the hypothesis that 8 weeks of treatment with AMS2392 will reduce liver fat
in youths with HS. We will perform a double-blind RCT in 48 male and female youths 13 to 18 years of age
(Tanner stage 4 or 5) with biopsy-documented HS. Liver fat content will be measured by magnetic resonance
imaging (MRI) at the outset and after the eight-week intervention.
Specific Aim 2. We propose that secondary end points of liver stiffness, body composition, insulin sensitivity,
and plasma concentrations of very-low density triglycerides (VLDL-TG), alanine transaminase (ALT), ApoB100,
creatinine and insulin sensitivity will be improved in the group receiving AMS2392 as compared to placebo.
Specific Aim 3. Adherence to protocol will be greater than 90% and there will be no adverse events in those
consuming AMS2392, including no change in plasma glutathione concentration.
 Completion of this RCT will provide information regarding efficacy, effect size, safety and tolerance that
will position us to successfully market AMS2392 as a medical nutrition product.

## Key facts

- **NIH application ID:** 10747273
- **Project number:** 1R44DK135312-01A1
- **Recipient organization:** AMINO COMPANY LLC, THE
- **Principal Investigator:** ROBERT R WOLFE
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $883,007
- **Award type:** 1
- **Project period:** 2023-09-20 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10747273

## Citation

> US National Institutes of Health, RePORTER application 10747273, Amino Acids and Pediatric Hepatic Steatosis (1R44DK135312-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10747273. Licensed CC0.

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