Novo Nordisk has reported headline results from the FLOW trial, where its semaglutide demonstrated a 24% reduction in kidney disease progression and mortality.
The parallel-group, superiority, double-blind, randomised, placebo-controlled study enrolled 3,533 subjects with type 2 diabetes and chronic kidney disease (CKD) at approximately 400 investigator sites across 28 countries.
It aimed to assess the superiority of 1.0mg injectable semaglutide compared to a placebo, alongside standard care, for preventing the risk of kidney impairment and kidney and cardiovascular mortality.
The trial was halted early due to its efficacy, following a recommendation from an Independent Data Monitoring Committee in October last year.
The primary endpoint was met with a statistically significant 24% reduction in the progression of kidney disease and death from kidney and cardiovascular causes among those treated with semaglutide versus the placebo.
Semaglutide also showed superiority over the placebo for confirmatory secondary endpoints.
The safety and tolerability profile of semaglutide 1.0mg was consistent with prior data.
Ozempic, a once-weekly subcutaneous injection of semaglutide, is currently approved for improving glycaemic control and reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Based on FLOW data, Novo Nordisk plans to seek regulatory approval for expanding Ozempic's label in the US and European Union (EU) this year.
Novo Nordisk Development executive vice-president Martin Holst Lange said: “We are very excited about the results from FLOW showing that semaglutide 1.0 mg reduces the risk of kidney disease progression.
“Approximately 40% of people with type 2 diabetes have chronic kidney disease, so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease.”
In another development, the US National Institutes of Health reported that semaglutide safely reduced liver fat by 31% in individuals with HIV and metabolic dysfunction-associated steatotic liver disease (MASLD).
This marks the first clinical trial of semaglutide for MASLD in people with HIV.
Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the NIH, the study was conducted in the US and Brazil by the AIDS Clinical Trials Group (ACTG).
