100-OR: ADA Presidents’ Select Abstract: Efficacy and Safety of Once-Weekly Tirzepatide, a Dual GIP/GLP-1 Receptor Agonist vs. Placebo as Monotherapy in People with Type 2 Diabetes (SURPASS-1)

Abstract

Tirzepatide (TZP) is a novel dual GIP/GLP-1 receptor agonist in development for type 2 diabetes (T2D). Efficacy and safety of TZP vs. placebo (PBO) was assessed in people with T2D inadequately controlled with diet and exercise alone. In this double-blind, PBO-controlled, 40-wk Phase 3 study, people with T2D (N=478; mean baseline [BL] HbA1c 7.94%; age 54.1 y; T2D duration 4.7 y; BMI 31.9 kg/m2) were randomized (1:1:1:1) to TZP (5, 10, 15 mg) or PBO. Primary efficacy measure was mean change in HbA1c from BL at 40 wk. Secondary measures were mean change in fasting serum glucose (FSG) and body weight (BW) and proportion achieving HbA1c and BW goals. TZP 5, 10 and 15 mg were superior to PBO in mean change in HbA1c at 40 wk (LSM treatment difference [95% CI]: -1.91% [-2.18, -1.63], -1.93% [-2.21, -1.65], -2.11% [-2.39, -1.83]; p In conclusion, TZP as T2D monotherapy demonstrated robust clinically meaningful reductions in HbA1c and BW without hypoglycemia (BG Disclosure J. Rosenstock: Board Member; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Consultant; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Research Support; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Genentech, Inc., Intarcia Therapeutics, Inc., Lexicon Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Oramed Pharmaceuticals, Inc., Pfizer Inc., REMD Biotherapeutics, Sanofi. C. H. Wysham: Other Relationship; Self; Abbott Laboratories, American Diabetes Association, Endocrine Society, Medscape Education, Novo Nordisk, Sanofi-Aventis, Research Support; Self; Eli Lilly and Company, Mylan N. V., Mylan N. V., Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc. J. P. 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. S. Kaneko: Advisory Panel; Self; Novo Nordisk Pharma Ltd., Consultant; Self; Novo Nordisk Pharma Ltd., Research Support; Self; Eli Lilly Japan K. K., Novo Nordisk Pharma Ltd., Speaker’s Bureau; Self; AstraZeneca, Eli Lilly Japan K. K., Mitsubishi Tanabe Pharma Corporation, Nippon Boehringer Ingelheim Co. Ltd., Novo Nordisk Pharma Ltd., Sumitomo Dainippon Pharma Co., Ltd. C. Lee: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. L. Fernandez lando: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. H. Mao: Employee; Self; Eli Lilly and Company. X. Cui: Employee; Self; Eli Lilly and Company. V. Thieu: None. Funding Eli Lilly and Company