In a first-quarter earnings report, Novo Nordisk announced promising initial data from a phase 2 trial testing the efficacy of glucagon-like peptide-1 agonist semaglutide (Ozempic) in individuals with nonalcoholic steatohepatitis (NASH).
In a first-quarter earnings report, Novo Nordisk announced promising initial data from a phase 2 trial testing the efficacy of glucagon-like peptide-1 (GLP-1) agonist semaglutide (Ozempic) in individuals with nonalcoholic steatohepatitis (NASH).
Ozempic was first approved in 2017 as a once-weekly GLP-1 indicated for patients with type 2 diabetes (T2D). In January 2020, the injectable treatment was approved for adult patients with T2D and known heart disease.
There are currently no approved pharmacological treatments for NASH. Recommendations for managing the disease include diet modification, exercise, and weight loss. According to the company, the promising results are “the largest NASH resolution improvement so far.”
In this 72-week multicenter, randomized, double-blind placebo-controlled study, patients with NASH were randomized to receive 1 of 3 doses (0.1 mg, 0.2 mg, or 0.4 mg) of subcutaneous semaglutide once daily or placebo.
At primary analysis, 230 of 320 participants had fibrosis stages F2 to F3. Researchers defined the primary end point as resolution of NASH and no worsening liver fibrosis. This end point was met for all participants who received semaglutide compared with placebo.
Liver biopsies performed at baseline and at the end of the trial revealed that of “patients receiving subcutaneous semaglutide 0.4 mg, 33 of 56 patients had NASH resolution compared to 10 of 58 patients on placebo (59% vs 17%).”
“The safety profile of subcutaneous semaglutide was consistent with the observed profile in other trials and disease areas,” the report noted. The most common adverse events reported were gastrointestinal events.
“Following the completion of the phase 2 trial, semaglutide in NASH is now being evaluated for further clinical trial development,” according to the report.
The condition is defined as fat and inflammation in one’s liver. This inflammation can lead to liver injury with healing. However, as healing progresses, scar tissue that is formed affects the liver more and more, leading to cirrhosis.
“The rate of progression is quite variable, both within patients and within families.…Patients tend to progress the longer they have the disease. We see some patients who have cirrhosis very early, but many times it’s patients in their 40s and 50s,” explained Norman Sussman, MD.
The disease takes both a physical and an economic toll on patients. Data presented at the 79th American Diabetes Association found that Medicare beneficiaries who had both diabetes and nonalcoholic fatty liver disease (NAFLD) or NASH had 2 times the mortality rate of the general population.
The combined economic costs of NAFLD and NASH are estimated to be slightly over $1 trillion per year in the United States, while the diseases are becoming the leading cause of liver transplants in the country.
Novo Nordisk reported increases in sales within diabetes and obesity care in the first quarter of 2020, potentially due to coronavirus disease 2019 (COVID-19) medication stocking. According to the report, Ozempic sold $688 million (DKK 4.76 billion) in the first quarter, more than tripling the DKK profit during the same period last year, 1.43 billion.