Kidney Week

Abstract: FR-PO0505

Ertugliflozin Effects on Cardiovascular, Kidney, and Inflammatory Biomarkers in VERTIS CV: Exploratory Analyses

Session Information

• CKM: Clinical - Trials, Epidemiology, and Biomarkers
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Cardiovascular-Kidney-Metabolic Health

• 602 Cardiovascular-Kidney-Metabolic Health: Clinical

Authors

• Kugathasan, Luxcia, Toronto General Hospital Research Institute and University Health Network, Toronto, Ontario, Canada

Luxcia Kugathasan, PhD

• Manimaran, Solaiappan, Merck & Co., Inc., Rahway, New Jersey, United States

Solaiappan Manimaran, PhD, MBA

• Fu, Wei, Merck & Co., Inc., Rahway, New Jersey, United States

Wei Fu, ScM

• Gantz, Ira, Merck & Co., Inc., Rahway, New Jersey, United States

Ira Gantz, MD

• Masiukiewicz, Urszula, Pfizer Inc., New York, New York, United States

Urszula Masiukiewicz, MD

• Frederich, Robert, Pfizer Inc., Groton, Connecticut, United States

Robert Frederich, MD, PhD

• Mancuso, James P., Pfizer Inc., Groton, Connecticut, United States

James P. Mancuso, PhD

• Cannon, Christopher Paul, Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, United States

Christopher Paul Cannon

• McGuire, Darren K., Division of Cardiology, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas, United States

Darren K. McGuire, MD, MS

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

Richard E. Pratley, MD

• Cherney, David, Toronto General Hospital Research Institute and University Health Network, Toronto, Ontario, Canada

David Cherney, MD, PhD

Background

VERTIS CV (NCT01986881) demonstrated noninferiority of the SGLT2 inhibitor ertugliflozin (ERTU) compared with placebo for MACE, in participants with type 2 diabetes (T2D) and established atherosclerotic disease.

Methods

Serum samples from a subset of VERTIS CV participants were used to assess changes from baseline in cardiorenal biomarkers at Weeks 18 and 52. Constrained longitudinal data analysis models were applied with change from baseline in log-transformed biomarkers as the response variable; treatment, visit and treatment-by-visit interaction as fixed effects; baseline biomarker level as a covariate; and inverse probability of selection weighting as weight. Analyses were performed on the placebo group and the pooled ERTU 5-mg and 15-mg dose groups.

Results

Most participants (70%) were male, with a mean age of 64 years, eGFR 76 mL/min/1.73 m², HbA1c 8.2% and duration of T2D of 13 years. The placebo-corrected effects of ERTU were as follows: Early reductions from baseline in the proinflammatory marker IL-12p40 and tubular injury marker NGAL were observed at Week 18 (GMR [95% CI]: 0.53 [0.41, 0.68] and 0.83 [0.73, 0.95], respectively; Figure) but were not sustained over time. Tubular injury marker KIM-1 was reduced at Week 52 (GMR [95% CI] 0.72 [0.53, 0.98]). Early placebo-corrected increases from baseline in cystatin C and the inflammatory markers eotaxin-1, GDF15 and hsCRP (GMR [95% CI]: 1.08 [1.03, 1.13], 1.24 [1.09, 1.40], 1.17 [1.05, 1.31] and 1.48 [1.19, 1.84], respectively) at Week 18 were not sustained over time and a small increase in high-sensitivity troponin T was observed at Week 52 (GMR [95% CI]: 1.11 [1.01, 1.23]).

Conclusion

In VERTIS CV, changes in cardiovascular, kidney and inflammatory biomarkers suggest ERTU may be associated with an evolution over time of anti-inflammatory and tubular protective effects.

Funding

• Commercial Support – The study and this analysis were funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA in collaboration with Pfizer Inc., New York, NY, USA