Research & Development

Scientific Background

Terminology

Alanine aminotransferase (ALT): A transaminase enzyme, found predominantly in the liver. ALT is commonly measured in blood as a part of a diagnostic evaluation of liver function tests to determine liver health. It is measured in international units/liter (IU/L). Normal values for female patients range within 5-38 IU/L; while for male patients normal values range within 10-50 IU/L1.

Aspartate aminotransferase (AST): AST catalyzes the reversible transfer of an α-amino group between aspartate and glutamate and, as such, is an important enzyme in amino acid metabolism. AST is found in the liver, heart, skeletal muscle, kidneys, brain, and red blood cells and may be elevated in diseases of these organs. AST is commonly measured in blood as a marker for liver health. Normal values for patients range within 6-40 IU/L2.

Body mass index (BMI): A measure for human body mass based on an individual’s weight and height (BMI= weight (KG)/[height(m)]2). BMI provides a simple numeric measure of a person’s thickness or thinness, allowing health professionals to discuss overweight and underweight problems more objectively with their patients. Normal BMI values for adults range from 18 to 25, where lower BMI values are considered underweight and higher BMI values are considered overweight (25-30) or obese (30-40) or morbidly obese (>40).

Liver cirrhosis: A condition of irreversible scarring of the liver, the end result of chronic liver damage caused by chronic liver diseases. Once cirrhosis develops, it is not possible to heal the liver or return its function to normal. It is a serious condition that can lead to severe complications, including liver transplantation or death.

Liver fibrosis: A scarring process – the formation of excess fibrous connective tissue – in response to injury. Fibrosis is not an independent disease but rather a histological change caused by liver inflammation.

Insulin resistance: A pathological condition in which cells fail to respond to the normal actions of the hormone insulin. Insulin resistance is associated with metabolic syndrome and can lead to type 2 diabetes.

Metabolic Syndrome: A name for a group of risk factors that occur together and increase the risk for coronary artery disease, stroke, and type 2 diabetes. Metabolic syndrome is characterized by having three or more of the following symptoms: high blood pressure, high fasting glucose levels, abdominal obesity; low HDL value; high Triglyceride value.

NAFLD Activity Score (NAS): An ordinal scoring system of pathological findings in liver biopsy that was developed as a tool to measure changes in NAFLD activity during therapeutic trials. NAS is defined as an unweighted sum of scores for steatosis (0–3), lobular inflammation (0–3), and ballooning (0–2), where a higher score reflects more active disease. Some studies have used threshold values of the NAS, specifically NAS ≥5, as a surrogate for the histologic diagnosis of NASH. Because of the issues relating to time course for a clinical trial, fibrosis was not included in the score. The NAS score is not intended to be used as a tool to diagnose NASH.

Type 2 Diabetes Mellitus (T2D or T2DM): Also known as adult-onset diabetes, T2DM is a metabolic disorder that is characterized by high blood glucose as the result of insulin resistance and relative insulin deficiency. Onset of type 2 diabetes can be delayed or prevented through proper nutrition and regular exercise.