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Semaglutide Kidney Outcomes Trial Ends Early; Findings Appear Positive

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10/17/2023
empr.com

Novo Nordisk has decided to stop its phase 3 kidney outcomes trial evaluating semaglutide in adults with type 2 diabetes and chronic kidney disease (CKD) based on interim data demonstrating efficacy.

The randomized, double-blind, parallel-group, placebo-controlled FLOW trial (ClinicalTrials.gov Identifier: NCT03819153) enrolled 3534 adults with type 2 diabetes and CKD. The trial compared semaglutide 1mg, a glucagon-like peptide-1 (GLP-1) receptor agonist, to placebo as an adjunct to standard of care on kidney outcomes to prevent the progression of renal impairment and risk of renal and cardiovascular (CV) mortality.

The primary outcome was the time to first occurrence of a composite primary outcome event, defined as persistent estimated glomerular filtration rate (eGFR) decline of greater than or equal to 50% from trial start, reaching end-stage renal disease, death from kidney disease, or death from CV disease. 

As per the trial protocol, an interim analysis was conducted when a prespecified number of primary endpoint events had occurred. Based on these findings, the trial’s independent data monitoring committee concluded that “the results (…) met certain prespecified criteria for stopping the trial early for efficacy.” The Company expects to have results from the FLOW trial available during the first half of 2024.

Semaglutide is currently marketed under the brand name Ozempic as adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus; and to reduce the risk of major CV events (eg, CV death, non-fatal MI or non-fatal stroke) in adults with type 2 diabetes mellitus and established CV disease.

References:

Novo Nordisk will stop the once-weekly injectable semaglutide kidney outcomes trial, FLOW, based on interim analysis. News release. Novo Nordisk. October 10, 2023. Accessed October 11, 2023. https://www.globenewswire.com/news-release/2023/10/10/2757941/0/en/Novo-Nordisk-will-stop-the-once-weekly-injectable-semaglutide-kidney-outcomes-trial-FLOW-based-on-interim-analysis.html

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Schedule28 May 2024