747-P: Baseline Characteristics of Subjects in the Once-Weekly (OW) Semaglutide FLOW Kidney Outcomes Trial

Abstract

Chronic kidney disease (CKD) is a common complication of type 2 diabetes (T2D) that increases the risk of kidney failure and cardiovascular (CV) disease. Data from CV outcomes trials suggest that glucagon-like peptide-1 receptor agonists have kidney-protective effects. The FLOW trial (NCT03819153) will evaluate kidney outcomes with OW semaglutide in subjects with T2D and CKD. FLOW is an ongoing randomized, double-blinded, multinational, phase 3b trial. Subjects (N=3,535) with T2D, estimated glomerular filtration rate (eGFR) ≥25-≤75 mL/min/1.73 m2, and urine albumin-to-creatinine ratio >100-<5,000 mg/g were assigned 1:1 to OW semaglutide 1.0 mg or placebo, plus standard-of-care. The primary endpoint is time to first occurrence of kidney failure (as measured by persistent eGFR <15 mL/min/1.73 2 or initiation of chronic dialysis or kidney transplantation) ; ≥50% persistent eGFR reduction compared with baseline; kidney or CV death. At baseline, 68.6% of subjects had HbA1c >7.0%, diabetes complications were common, and 15.5% were taking a sodium-glucose co-transporter-2 inhibitor (Table) . The majority of subjects (68.2%) were at very high risk for CKD progression (Kidney Disease: Improving Global Outcomes criteria) . Subjects enrolled in FLOW had substantial diabetes burden and risk for CKD progression. FLOW will assess kidney outcomes with OW semaglutide in this population. Disclosure R.E.Pratley: Other Relationship; Bayer AG, Corcept Therapeutics, Dexcom, Inc., Hanmi Pharm. Co., Ltd., Merck & Co., Inc., Metavention, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. V.Perkovic: Advisory Panel; Astellas Pharma Inc., Baxter, DURECT Corporation, Merck & Co., Inc., Metavant Sciences, Mundipharma, Relypsa Inc., Other Relationship; AbbVie Inc., AstraZeneca, Bayer AG, Bristol-Myers Squibb Company, Dimerix, Eli Lilly and Company, Eli Lilly and Company, Gilead Sciences, Inc., GlaxoSmithKline plc., Janssen Research & Development, LLC, Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K., Novo Nordisk, Novo Nordisk, Otsuka America Pharmaceutical, Inc., Pfizer Inc., Sanofi, Servier Laboratories, Tricida, Inc., UpToDate. F.M.M.Baeres: Employee; Novo Nordisk, Stock/Shareholder; Novo Nordisk. G.Bakris: Consultant; Alnylam Pharmaceuticals, Inc., AstraZeneca, DiaMedica Therapeutics, Inc., Horizon Therapeutics plc, Ionis Pharmaceuticals, Merck & Co., Inc., Other Relationship; Novo Nordisk. J.Lawson: Employee; Novo Nordisk A/S. K.W.Mahaffey: Consultant; Novo Nordisk. J.F.Mann: Advisory Panel; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. H.Mersebach: Employee; Novo Nordisk A/S. P.Rossing: Consultant; Astellas Pharma Inc., AstraZeneca, Bayer AG, Gilead Sciences, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Speaker's Bureau; Eli Lilly and Company. K.R.Tuttle: Advisory Panel; Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Consultant; AstraZeneca, Eli Lilly and Company, Research Support; Bayer AG, Goldfinch Bio, Inc., Novo Nordisk, Travere.