102-OR: Efficacy and Safety of Once-Weekly Efpeglenatide vs. Placebo as Monotherapy in Patients with Type 2 Diabetes (AMPLITUDE-M)

Abstract

Efpeglenatide (Efpeg) is being developed as a long-acting GLP-1 receptor agonist for once weekly, subcutaneous administration. The efficacy and safety of Efpeg vs. placebo (PBO) was assessed in patients with type 2 diabetes (T2D) inadequately controlled with diet and exercise alone. In this double-blind, PBO-controlled, 30+26-week Phase 3 study, patients with T2D were randomized to Efpeg 2 mg (n=100), 4 mg (n=101), and 6 mg (n=103), or PBO (n=102). Endpoints were change from baseline in HbA1c at week 30 (primary) and other parameters of glycemic control, body weight (BW) and safety at weeks 30 and 56 (secondary). Baseline characteristics and key results are shown in the Table. All doses of Efpeg showed significantly greater reductions in HbA1c vs. PBO at weeks 30 and 56, and a greater proportion of patients achieved HbA1c In conclusion, Efpeg as monotherapy in patients with T2D was well tolerated and demonstrated significant improvements versus PBO in HbA1c and BW after 30 weeks of treatment. These improvements generally remained stable through 56 weeks of therapy. Disclosure S. Baek: Employee; Self; Hanmi Pharmaceutical. 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. L. Popescu: Employee; Self; Sanofi. E. Niemoeller: Employee; Self; Sanofi-Aventis Deutschland GmbH, Stock/Shareholder; Self; Sanofi. I. Muehlen-bartmer: Employee; Self; Sanofi-Aventis Deutschland GmbH. 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.