Study: Nidufexor as a Treatment for NASH

Research was presented at The Digital International Liver Congress that proved nidufexor is a safe and viable treatment for nonalcoholic steatohepatitis (NASH), according to Healio. It was shown to reduce body weight, aminotransferase levels, and hepatic fat fraction as well.

About NASH

Nonalcoholic steatohepatitis (NASH) is a disease that is characterized by a buildup of fat in the liver that causes inflammation and liver damage. This disease affects those who drink very little or not at all, but it mimics the liver disease of heavy drinkers. The liver damage has the potential to cause enough scar tissue that it prevents the liver from functioning. It affects up to one quarter of the people in the United States.

There is a debate about the cause of NASH. Some healthcare professionals believe that it is inherited, while others think it is triggered by environmental factors. The exact cause is unknown, but there are risk factors that are known to increase the chance of developing NASH. These include obesity, type 2 diabetes, high cholesterol, and metabolic syndrome. NASH is not always symptomatic, and it does not always progress. Symptoms can vary from person to person. Some of these symptoms include weakness, fatigue, weight loss, nausea, vomiting, loss of appetite, jaundice, itching, mental confusion, abdominal pain, swelling in the legs or abdomen, and spider-like blood vessels.

About the Study

The study was conducted by Richard Aspinall and his colleagues at Queen Alexandra Hospital. The study, which was placebo-controlled and double-blind, saw 121 participants take either a placebo, 50 mg of nidufexor, or 100 mg of nidufexor for 12 weeks. The primary endpoints were to ensure the safety of the drug and reduce ALT. Aspinall named the other endpoints as lipid profiles, pharmacokinetics, hepatic fat, and anthropometry.

94 participants completed the study and reported nidufexor to be safe and well-tolerated. While there were adverse events, they were minor and typically in the 100 mg group.

Researchers also found that ALT levels were reduced by 33% in the 100 mg group and 31% in the 50 mg, which is comparable to only 8% in the placebo group. In terms of hepatic fat, the 50 mg group saw a 29% decrease, while the 100 mg group saw a 32% decrease. Body weight dropped by 2.1 kg in the 100 mg group and .31 in the 50 mg group as well.

The results of this study are positive, which is encouraging and points to nidufexor as a viable treatment for NASH.

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