78-LB: Efficacy and Safety of Tirzepatide, a Dual GIP/GLP-1 Receptor Agonist, Compared with Insulin Degludec in Patients with Type 2 Diabetes (SURPASS-3)

Abstract

Tirzepatide (TZP) is a novel dual GIP/GLP-1 receptor agonist under development for the treatment of type 2 diabetes (T2D). The efficacy and safety of TZP vs. titrated insulin degludec (IDeg) were assessed in insulin-naive patients with T2D inadequately controlled on metformin with/without SGLT-2i. In this open-label, 52-week, Phase 3 study, 1444 patients with T2D were randomized (1:1:1:1) to once-weekly TZP (5, 10, 15 mg) or once-daily IDeg (mean baseline [BL] age, 57.4 years; T2D duration, 8.4 years; HbA1c, 8.17%; BMI, 33.5 kg/m2; 32% on SGLT-2i). The primary efficacy endpoint was mean change in HbA1c from BL to Week 52. Secondary efficacy endpoints included mean change in fasting serum glucose (FSG) and body weight (BW) and proportion of subjects achieving HbA1c and BW goals. All TZP doses were superior to IDeg in mean change from BL in HbA1c and BW, and in the proportion of patients achieving all HbA1c and BW goals at Week 52 (Table). Among patients taking TZP 15 mg, 48.4% achieved HbA1c Disclosure B. Ludvik: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Research Support; Self; Amgen Inc., Eli Lilly and Company, Novo Nordisk, Speaker’s Bureau; Self; MSD Corporation. F. Giorgino: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk, Roche Diabetes Care, Sanofi, Research Support; Self; Lilly Diabetes, Roche Diabetes Care. E. Jodar: Other Relationship; Self; AstraZeneca, Lilly Diabetes, Mundipharma International, Novo Nordisk, Speaker’s Bureau; Self; Boehringer Ingelheim International GmbH. J. Frias: Consultant; Self; 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi, Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, CymaBay Therapeutics, Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi, Speaker’s Bureau; Self; Merck & Co., Inc., Sanofi. L. Fernandez lando: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. K. Brown: Employee; Self; Eli Lilly and Company. R. Bray: None. A. Rodriguez: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. Funding Eli Lilly and Company