Kidney Week

Abstract: SA-PO1155

Effect of Semaglutide on Kidney Outcomes: Pooled Analysis of the SELECT, FLOW, and SOUL Trials

Session Information

• CKD: SGLT2 Inhibitors and GLP-1 RAs for Kidney Health
  November 08, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Mann, Johannes F., KfH Kidney Centre, München, Germany

Johannes F. Mann, MD

• Badve, Sunil, Renal and Metabolic Division, The George Institute for Global Health, Sydney, New South Wales, Australia

Sunil Badve, MD, MBBS, PhD, FASN

• Baeres, Florian M.M., Novo Nordisk A/S, Søborg, Denmark

Florian M.M. Baeres, MD

• Belmar, Nicolas, Novo Nordisk A/S, Søborg, Denmark

Nicolas Belmar, MD, MS, MSc

• Brown-Frandsen, Kirstine Stougaard, Novo Nordisk A/S, Søborg, Denmark

Kirstine Stougaard Brown-Frandsen, MD

• Buse, John, University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States

John Buse, MD, PhD

• Colhoun, Helen, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, United Kingdom

Helen Colhoun, MD, MBChB

• Deanfield, John, University College London Institute of Cardiovascular Science, London, England, United Kingdom

John Deanfield

• Engelmann, Mads David Malling, Novo Nordisk A/S, Søborg, Denmark

Mads David Malling Engelmann, MD

• Hovingh, Kees, Novo Nordisk A/S, Søborg, Denmark

Kees Hovingh, MD, PhD

• Idorn, Thomas, Novo Nordisk A/S, Søborg, Denmark

Thomas Idorn, MD, PhD

• Lincoff, A. Michael, Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, United States

A. Michael Lincoff, MD

• Lingvay, Ildiko, Department of Internal Medicine/Endocrinology and Peter O’Donnell Jr. School of Public Health, University of Texas Southwestern Medical Center, Dallas, Texas, United States

Ildiko Lingvay

• Mahaffey, Kenneth W., Stanford Center for Clinical Research, Department of Medicine, Stanford School of Medicine, Palo Alto, California, United States

Kenneth W. Mahaffey, MD

• McGuire, Darren K., Department of Internal Medicine, University of Texas Southwestern Medical Center, and Parkland Health System, Dallas, Texas, United States

Darren K. McGuire, MD, MS

• Pratley, Richard E., AdventHealth Translational Research Institute, Orlando, Florida, United States

Richard E. Pratley, MD

• Rasmussen, Soren, Novo Nordisk A/S, Søborg, Denmark

Soren Rasmussen, PhD

• Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Capital Region of Denmark, Denmark

Peter Rossing, MD, DrMed

• Sattar, Naveed, University of Glasgow School of Cardiovascular & Metabolic Health, Glasgow, Scotland, United Kingdom

Naveed Sattar, MBChB, PhD

• Tuttle, Katherine R., University of Washington Division of Nephrology, Seattle, Washington, United States

Katherine R. Tuttle, MD, FASN

• Perkovic, Vlado, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia

Vlado Perkovic, MBBS, PhD, FASN

Group or Team Name

• The FLOW Trial Investigators.

Background

Pooled analyses of individual participant data from the SELECT, FLOW, and SOUL trials were conducted to determine the effect of semaglutide on pre-specified major kidney outcomes in participants with or without type 2 diabetes.

Methods

Participants were randomized to receive semaglutide (once-weekly subcutaneous 1.0 mg/2.4 mg [FLOW/SELECT] or once-daily oral 14 mg [SOUL]) vs placebo. The main outcome was time to first occurrence of a 5-point chronic kidney disease composite (defined in figure).

Results

A total of 30,787 participants were included. Compared with placebo, pooled semaglutide consistently reduced the risk of the main 5-point composite outcome (hazard ratio [HR] 0.84 [95% CI 0.77, 0.91]), a kidney-specific outcome excluding cardiovascular (CV) death (HR 0.80 [95% CI 0.69, 0.92]) (Figure), and kidney failure (estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m² or initiation of chronic kidney replacement therapy; HR 0.83 [95% CI 0.69, 1.00]). No indication of treatment heterogeneity was observed for any kidney outcomes across baseline eGFR groups (<60 or ≥60 mL/min/1.73 m²; interaction p values >0.1). Serious adverse events were reported in 6130 participants (39.8%) assigned pooled semaglutide and 6581 (42.8%) assigned placebo.

Conclusion

Semaglutide reduced the risk of pre-specified major kidney outcomes in a broad population with CV-kidney-metabolic disease, irrespective of baseline eGFR.

Funding

• Commercial Support – The SELECT, FLOW, and SOUL trials were funded by Novo Nordisk A/S

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.2025vd9epqq7