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Novo Stops Semaglutide Kidney Outcomes Trial Early for Efficacy
The phase 3 semaglutide kidney outcomes trial will be stopped immediately with FLOW read out expected in early 2024, the company said.
Novo Nordisk announced on October 10, 2023, the company’s decision to discontinue the phase 3 FLOW trial following a recommendation from the trial’s independent Data Monitoring Committee indicating that an interim analysis of the kidney outcomes trial for weekly semaglutide had met the prespecified criteria for stopping the trial early for efficacy.
The process of closing the trial will be initiated, according to the announcement, and the company will remain blinded to the results until trial completion. Novo 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. The trial’s 5-point composite primary endpoint comprises:
- 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
- Death from cardiovascular disease
Investigators also specified multiple secondary outcomes including annual rate of change in eGFR, 3-point major adverse cardiovascular events, and all-cause death. The FLOW trial has enrolled 3534 participants from 28 countries across more than 400 investigator sites, said Novo Nordisk.
Most recently, Novo Nordisk announced findings from the phase 3 SELECT trial, which met its primary endpoint demonstrating that 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.
