Novo Nordisk Halts Semaglutide Kidney Outcomes Trial for Early Efficacy

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Novo Nordisk has announced the decision to discontinue the FLOW trial based on a recommendation from the trial’s independent Data Monitoring Committee indicating an interim analysis of the kidney outcomes trial for weekly semaglutide had met certain prespecified criteria for stopping the trial early for efficacy.

According to the October 10, 2023 announcement from the company, the process of closing the trial will be initiated, but Novo Nordisk pointed out it remains blinded to the results until trial completion and expects a readout of the FLOW trial to occur during the first half of 2024.

Launched in 2019, FLOW is a randomized, double-blind, parallel-group, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg against placebo therapy as an adjunct to standard of care on kidney outcomes in people with type 2 diabetes and chronic kidney disease. With this in mind, the trial was designed with a composite primary endpoint consisting of:

• Onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI2 equation compared with baseline
• Onset of persistent eGFR (CKD-EPI2) < 15 mL/min/1.73 m2,
• Initiation of chronic kidney replacement therapy
• Death from kidney disease or death from cardiovascular disease in people with type 2 diabetes and chronic kidney disease.

The trial was also designed with multiple secondary outcomes of interest including annual rate of change in eGFR1, 3-point major adverse cardiovascular events, and all-cause death. According to Novo Nordisk, the trial has enrolled 3534 participants from 28 countries across more than 400 investigator sites.

The announcement of Novo Nordisk’s decision comes less than 2 months before the planned presentation of the SELECT trial at the American Heart Association 2023 annual meeting, which Novo Nordisk announced met its primary endpoint by demonstrating the use of semaglutide 2.4 mg was associated with a 20% reduction in relative risk of major adverse cardiovascular events in patients with overweight and obesity.

References:

1. Novo Nordisk. Novo Nordisk will stop the once-weekly injectable semaglutide kidney outcomes trial, FLOW, based on interim analysis. Novo Nordisk. October 10, 2023. Accessed October 11, 2023. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=166327.
2. Campbell P. Select trial shows semaglutide 2.4 mg could reduce cardiovascular risk. HCP Live. August 8, 2023. Accessed October 11, 2023. https://www.hcplive.com/view/select-trial-shows-semaglutide-2-4-mg-could-reduce-cardiovascular-risk.