Milestone Number 2

Semaglutide Hits a Milestone in NASH

Nonalcoholic steatohepatitis – NASH – is a more severe form of fatty liver disease that can lead to cirrhosis and liver cancer. Like other complications of obesity, people can develop NASH even if their BMI does not fall into the range of obesity. Just like obesity, the prevalence of NASH is growing and the treatment options are rare. Thus, it was good news yesterday to learn that semaglutide hit a critical milestone for treating NASH.

In a phase 2 study, semaglutide met its primary endpoint, proving superior to placebo for resolution of NASH with no worsening of liver fibrosis.

Still Early for Semaglutide in NASH

This is definitely good news – both for people who need better options for treating NASH and for Novo Nordisk. A well-designed phase 2 study tells us if a drug can work and the answer for semaglutide yesterday was pretty clearly yes.

However, failures litter the landscape of drug development for treating NASH. Most notable was the failure of selonsertib in three late stage studies last year. In a word, the drug bombed. It happens – especially when people are working on a disease where the treatment options are scant.

So we can hardly be sure that semaglutide will be a winner when all the data come in. But we do have the comfort of knowing that it works well in diabetes, and it appears to have a good profile in obesity. Both of these diseases go hand in hand with NASH.

“Grossly Underdiagnosed”

A new study of the fatty liver disease and its progression to cirrhosis and death tells us that this condition is both serious and often unrecognized until it’s too late. Rohit Loomba and colleagues published their findings in Alimentary Pharmacology and Therapeutics. Examining patient records from Medicare, they found a prevalence of 5.7 percent for fatty liver disease. With eight years of follow-up, they found that it progressed to cirrhosis in 39 percent of patients. Among patients with cirrhosis, 31 percent died.

The authors conclude that fatty liver disease is grossly underdiagnosed in real-world clinical settings. They write:

Furthermore, the late identification of NAFLD/NASH in real‐world clinical practice and the high clinical burden found in this study for Medicare patients have broad public health implications. Proper identification and treatment of NAFLD/NASH prior to Medicare eligibility could obviate the clinical consequences that will ultimately impact the Medicare population.

In other words, the need for better identification and treatment of fatty liver disease is great. Yesterday’s news that semaglutide might work for NASH is an encouraging milestone in that direction. Another drug, obeticholic acid, is due for an FDA hearing next month for treating NASH.

We may soon have more options for treating this disease.

Click here and here for more on semaglutide in NASH. For the Loomba study, click here.

Milestone Number 2, photograph © Rich Renomeron / flickr

Subscribe by email to follow the accumulating evidence and observations that shape our view of health, obesity, and policy.


May 7, 2020