FLOW Trial Results Demonstrate Positive Kidney Outcomes With Semaglutide

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Article

In the study, investigators found superior kidney outcomes with injectable semaglutide (Ozempic) for individuals with type 2 diabetes and chronic kidney disease.

Headline results from the FLOW (NCT03819153) trial demonstrated superior kidney outcomes with injectable semaglutide (Ozempic; Novo Nordisk) compared to the placebo for individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD).1 The results follow the announcement to stop the FLOW trial early due to efficacy based on a recommendation from an independent data monitoring committee.1,2 The results from an interim analysis met the pre-specified criteria for stopping the trial early.2

"We are very excited about the results from FLOW showing that semaglutide 1.0 mg reduces the risk of kidney disease progression,” Martin Holst Lange, executive vice president for Development at Novo Nordisk, said in a press release. “Approximately 40% of people with [T2D] have [CKD], so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with [T2D] and [CKD].”1

About the FLOW Clinical Trial

Trial Name: A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

ClinicalTrials.gov ID: NCT03819153

Sponsor: Novo Nordisk A/S

Completion Date (Estimated): August 2024

The double-blind trial was designed to compare semaglutide 1.0 mg with a placebo as an adjunct to the standard of care to prevent the progression of kidney impairment and reduce the risk of kidney and cardiovascular disease in 3522 individuals with T2D with CKD. The trial was conducted in 28 countries with approximately 400 investigator sites and was initiated in 2019.1

The primary end point included 5 components that measured progression of CKD and mortality, and both the CKD and cardiovascular components contributed to the risk reduction. The 5 components included: onset of persistent 50% or greater reduction in estimated glomerular filtration rate (eGFR) compared with baseline, onset of persistent eGFR of less than 15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy, including dialysis or kidney transplantation, death from kidney disease, and/or death from cardiovascular disease.1

Secondary end points included the annual rate of change in eGFR, major adverse cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, and all-cause death.1

The results met the primary endpoint, demonstrating statistically significant and superior reductions in kidney disease progression and kidney and cardiovascular-related death for 24% of individuals treated with semaglutide. The superiority of semaglutide continued for the confirmatory secondary end points and had a safe and well-tolerated profile that was similar to previous safety of semaglutide 1.0 mg in other trials.1

Novo Nordisk will file for regulatory approvals of the label expansion for the medication in both the United States and the European Union in 2024, with detailed results from the FLOW trial being presented at a scientific conference in 2024, according to the press release.1

Currently, the drug is approved as a once-weekly subcutaneous injection in 0.5 mg, 1.0 mg, and 2.0 mg doses as an adjunct to diet and exercise to improve glycemic control in adults with T2D and to reduce the risk of major adverse cardiovascular adults with T2D and cardiovascular disease.1

References
  1. Novo Nordisk A/S: Semaglutide 1.0 mg demonstrates 24% reduction in the risk of kidney disease-related events in people with type 2 diabetes and chronic kidney disease in the FLOW trial. News release. Novo Nordisk. March 5, 2024. Accessed March 5, 2024. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=167028
  2. 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 March 5, 2024. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=166327
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