Promising Results in Phase 3 NASH Clinical Trial

According to a story from Healio, in a phase 3 clinical trial, treatment with the drug resmetirom was able to achieve the desired endpoints at 52 weeks in people living with nonalcoholic steatohepatitis (NASH). The evaluation of the drug’s efficacy and safety in this study involved a total of 966 patients. These patients had an average age of 57 years and had a diagnosis confirmed via biopsy. The patients all presented with fibrosis (liver scarring) ranging from F1b stage to F3 stage.

About Nonalcoholic Steatohepatitis (NASH)

NASH is a type of liver disease in which fat is deposited in the liver independent of excessive alcohol consumption. This disease can progress rapidly. Risk factors include metabolic syndrome and insulin resistance. There also appears to be some genetic component to the disease as well. This condition also increases the risk of other health problems and liver cancer. Men also seem to be at greater risk, getting the disease as almost twice the rate that women do. Symptoms of NASH include jaundice, malaise, fatigue, and abdominal pain or discomfort. Without treatment, the liver can become scarred, and the patient may need a liver transplant. However, the condition can also be managed with proper diet, the use of certain medications, and exercise. To learn more about NASH, click here.

About Resmetirom

This drug is classified as a liver-targeted thyroid hormone receptor (THR) -beta-selective agonist and is intended to intervene in the impacts of lipotoxicity in the liver, which impacts the hepatic thyroid function. This function is mediated by THR beta. This intervention is intended to improve NASH in several aspects, such as reduction of excess liver fat.

About the Trial

Patients received either an 80 mg or 100 mg dose once daily. Endpoints included resolution of NASH without worsened fibrosis, or a one stage fibrosis improvement without worsened fatty liver disease activity score. Changes in LDL cholesterol levels were also evaluated in the study.

In the placebo group, 10% saw resolution of NASH and 14% saw one stage of fibrosis improvement. The 80 mg cohort saw 26% resolution and 24% fibrosis improvement; this increased to 30% resolution and 26% fibrosis improvement in the 100 mg cohort. Overall, these results demonstrate meaningful improvements and superiority over placebo.

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