Ozempic® (semaglutide) injection 1 mg demonstrated reduction in risk of kidney disease-related events in Phase 3 FLOW trial presented at the 84th Scientific Sessions of the American Diabetes Assoc...

24.06.24 19:30 Uhr

  • Semaglutide 1 mg demonstrated a statistically significant and superior reduction of 24% in the risk of kidney disease-related events vs. placebo in adults with type 2 diabetes and chronic kidney disease.
  • Based on FLOW trial data, Novo Nordisk submitted a label extension application for Ozempic®, which has been accepted for review by the FDA.

PLAINSBORO, N.J., June 24, 2024 /PRNewswire/ -- Novo Nordisk today presented the full results from FLOW, its phase 3b kidney outcomes trial investigating the effects of once-weekly injectable semaglutide 1 mg in adults with type 2 diabetes and chronic kidney disease (CKD), at the 84th Annual Scientific Sessions of the American Diabetes Association (ADA). The double-blind, randomized, placebo-controlled trial, which enrolled 3,533 people with type 2 diabetes and CKD, achieved its primary endpoint, with semaglutide 1 mg demonstrating a 24% reduction in the risk of kidney disease progression and cardiovascular and kidney mortality compared to placebo (331 vs. 410 events; hazard ratio: 0.76 [0.66; 0.88]; P=0.0003).1 The primary outcome was major kidney disease events, a composite of onset of kidney failure (initiation of long-term dialysis, kidney transplantation, or a reduction in the eGFR to <15 ml per minute per 1.73 m2 sustained for ≥28 days), a sustained (for ≥28 days) 50% or greater reduction in eGFR from baseline, or death from kidney-related or cardiovascular causes.1

"Treating serious comorbidities like chronic kidney disease is critical to improving treatment outcomes for people with type 2 diabetes. The results from the FLOW trial represent important data, as we look to better understand what GLP-1 treatment options could mean for this patient population," said Anna Windle, PhD, senior vice president clinical development, Medical & Regulatory Affairs at Novo Nordisk. "Leveraging our deep expertise in cardiometabolic science, we are proud to continue building strong clinical evidence on the strength and versatility of semaglutide to deliver results for people living with serious chronic diseases."

Additionally, the study found that semaglutide 1 mg demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including a significant reduction in the mean annual glomerular filtration rate (eGFR) slope by 1.16 ml/min/1.73 m²/year (−2.19 vs. −3.36 ml/min/1.73 m²/year [0.86; 1.47]; P<0.001). The risk of major cardiovascular events was significantly lower in the semaglutide group than in the placebo group (212 vs. 254 events; hazard ratio: 0.82; [0.68; 0.98]; P=0.029). The risk of death from any cause was significantly lower in the semaglutide group than in the placebo group (227 vs. 279 events; hazard ratio: 0.80 [0.67; 0.95]; P=0.01).1

Serious adverse events were reported in fewer participants in the semaglutide group than in the placebo group (877 [49.6%] vs. 950 [53.8%]). Prespecified adverse events of special interest (≥5%) for participants in the semaglutide and placebo groups, respectively, included diabetic retinopathy (402 [22.8%] vs. 398 [22.5%], Covid-19-related disorder (358 [20.3%] vs. 404 [22.9%]), serious cardiovascular disorder (273 [15.4%] vs. 319 [18.1%], heart failure (133 [7.5%] vs. 175 [9.9%]), acute kidney failure (172 [9.7% vs. 182 [10.3%]), malignant tumor (120 [6.8%] vs. 104 [5.9%]) and serious gastrointestinal disorder (95 [5.4%] vs. 94 [5.3%]). Adverse events leading to permanent discontinuation of semaglutide or placebo were more common in the semaglutide group than in the placebo group (233 [13.2%] vs. 211 [11.9%]); this finding was driven mainly by discontinuation because of gastrointestinal disorders (79 [4.5%] vs. 20 [1.1%]).1

Novo Nordisk stopped the FLOW study early based on a recommendation from an Independent Data Monitoring Committee due to meeting pre-specified efficacy criteria after a median follow-up of 3.4 years.

Based on data from the FLOW clinical trial, Novo Nordisk submitted a label extension application for Ozempic®, which has been accepted for review by the U.S. Food & Drug Administration (FDA). A decision is anticipated in January 2025. Data from the FLOW trial were previously presented in May at the 61st European Renal Association Congress and simultaneously published in the New England Journal of Medicine.1

About FLOW

FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing injectable semaglutide 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the risk of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and CKD (defined as eGFR2 ≥50 and ≤75mL/min/1.73 m2 and UACR >300 and <5000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 and UACR >100 and <5000 mg/g). 3,533 people (1,767 in the semaglutide group and 1,766 in the placebo group) were enrolled in the trial conducted in 28 countries at around 400 investigator sites. The FLOW trial was initiated in 2019.1

The key objective of the FLOW trial was to demonstrate delay in the progression of CKD and a lower risk of kidney and cardiovascular mortality through the composite primary endpoint consisting of the following five components: onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI3 equation compared with baseline, onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy (dialysis or kidney transplantation), death from kidney disease or death from cardiovascular disease. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) and all-cause death.1

About CKD

CKD affects more than 800 million people worldwide2, and its prevalence is expected to rise with an aging demographic and increasing incidence of diabetes. CKD is a common complication of type 2 diabetes, with approximately 40% of people with type 2 diabetes also experiencing CKD.3 For people with type 2 diabetes, CKD imparts a considerable burden and is a major cause of morbidity, including increased cardiovascular risk and mortality.4

Despite the availability of effective therapies, a significant residual risk of CKD progression and cardiovascular events remains in people with type 2 diabetes.5

About Ozempic® 

Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is a once-weekly glucagon-likepeptide-1 (GLP-1) receptor agonist indicated along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and commercial, production and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.

Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications.

Contacts for further information

Media:


Allison Schneider (US)
+1 732 513 4875 (Mobile)
aocd@novonordisk.com 

Ambre James-Brown (Global)
+45 3079 9289 (Direct)

abmo@novonordisk.com





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References

  • Perkovic V, Tuttle KR, Rossing P, et al.. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. New England Journal of Medicine. 2024. https://doi.org/10.1056/nejmoa2403347
  • Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl. 2022. 12(1): 7–11. https://doi.org/10.1016/j.kisu.2021.11.003
  • von Scholten BJ, Kreiner FF, Rasmussen S, Rossing P, Idorn T. (2022). The potential of GLP-1 receptor agonists in type 2 diabetes and chronic kidney disease: from randomised trials to clinical practice. Ther Adv Endocrinol Metab. 2022; 13, 20420188221112490. https://doi.org/10.1177/20420188221112490
  • de Boer IH, Rue TC, Hall YN, et al. Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA. 2011;305:2532-9.
  • de Boer IH, Khunti K, Sadusky T, et al. (2022). Diabetes management in chronic kidney disease: a consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO). Diabetes care. 2022; 45(12); 3075–3090. https://doi.org/10.2337/dci22-0027
  • Novo Nordisk is a registered trademark of Novo Nordisk A/S.
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