HQ Team
March 6, 2024: Novo Nordisk’s diabetes drug Ozempic delayed the progression of kidney disease and cardiovascular and kidney deaths in 24% of people involved in trials, the company announced.
The Denmark-based company stopped the trial on October 10, 2023, based on a recommendation from an Independent Data Monitoring Committee as it met efficacy goals.
The combined primary endpoint included five components measuring the progression of chronic kidney disease (CKD) and the risk of kidney and cardiovascular mortality.
“Both chronic kidney disease and cardiovascular components of the primary endpoint contributed to the risk reduction,” according to a statement.
3,533 people enrolled
The trial achieved its primary endpoint by “demonstrating a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24% for people treated with semaglutide 1mg compared to placebo.”
The experiment enrolled 3,533 people with type 2 diabetes and chronic kidney disease. The company’s semaglutide is marketed as Ozempic.
Martin Holst Lange, executive vice president for Development at Novo Nordisk said: “Approximately 40% of people with type 2 diabetes have chronic kidney disease, so the positive results….demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease.”
Glucagon-like peptide-1 (GLP-1) agonists represent a class of medications used to treat Type 2 diabetes mellitus and, in some cases, obesity, according to the National Institutes of Health.
GLP-1 drugs mimic the action of the hormone glucagon-like peptide-1 and suppress appetite by mimicking the gut hormones.
Fatty liver study
In a study done by the National Institutes of Health, a weekly injection of semaglutide was safe and reduced the amount of fat in the liver by 31% in people with HIV and metabolic dysfunction-associated steatotic liver disease (MASLD).
This is the first clinical trial of semaglutide for MASLD in people with HIV, according to a statement.
Previously known as nonalcoholic fatty liver disease, MASLD is characterized by the accumulation of excess fat in the liver that is not caused by alcohol consumption or viral hepatitis.
It is the most common cause of chronic liver disease in the US and a leading reason for liver transplantation.
In line with previous studies by Novo, semaglutide had a “safe and well-tolerated” profile, according to the statement.
Novo Nordisk expects to file for regulatory approvals for a label expansion for Ozempic in the US and EU in 2024.
The detailed results from the Novo trial will be presented at a scientific conference in 2024.
