According to a story from Healio, encouraging results from a phase 2 trial could herald a new standard of treatment for metabolic dysfunction-associated steatohepatitis (MASH). The investigational therapy is called survodutide and it’s classified as an agonist of glucagon-like peptide-1 receptors (GLP-1). In this study, 48 weeks of treatment produced notable improvements without progression of liver fibrosis (scarring).
Trial Findings
This phase 2 clinical trial involved a total of 295 patients with a confirmed diagnosis of MASH with liver fibrosis. It was a placebo controlled, double-blind style study. Patients were treated with a weekly dose of survodutide that was administered subcutaneously. This was a dose escalation study, with dose levels of 2.4 mg, 4.8 mg, or 6 mg being used. The trial achieved its primary endpoint at the 48-week mark of improvement in MASH demonstrated via biopsy without scarring progression. Over 80% of the patients that received the therapy saw statistically meaningful improvement versus just 18% in the placebo arm.
The drug also achieved all of the trial’s secondary endpoints, the principal one being significant improvement of fibrosis in the liver. These findings are encouraging and suggest the survodutide could become a first-class treatment for MASH.
About Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic dysfunction-associated steatohepatitis (MASH) is a type of liver disease in which fat is deposited in the liver independent of excessive alcohol consumption. Formerly called nonalcoholic steatohepatitis (NASH), 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 MASH 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 MASH, click here.
