Abstract
Efpeglenatide (EFPEG) is a long-acting GLP-1 RA, administered by once-weekly (QW) subcutaneous injection, currently being developed to improve glycemic control in patients with T2D. EXCEED 203 (NCT02057172), a 12-week study of EFPEG (0.3, 1, 2, 3, or 4 mg QW) compared with placebo (PBO) and referenced to open-label liraglutide 1.8 mg in uncontrolled T2D (naïve/metformin monotherapy), found significantly improved HbA1c for all doses of EFPEG ≥1 mg, and reductions in body weight for EFPEG 3 and 4 mg. This exploratory subanalysis investigated any potential relationship between glycemic control and weight loss effects observed in EXCEED 203. At all EFPEG doses ≥1 mg and in two combined populations (low-dose group: EFPEG 1 and 2 mg; high-dose group: EFPEG 3 and 4 mg) vs. PBO, greater proportions of patients significantly achieved the composite endpoint of HbA1c <7% and weight loss >3 kg (p<0.05 for all; Table). Linear regression analysis revealed no correlation between change in HbA1c and change in body weight throughout the study for all EFPEG doses ≥1 mg. EFPEG was well tolerated with adverse events mirroring those known for GLP-1 RAs. In conclusion, EFPEG was associated with greater proportions of patients achieving the composite endpoint of HbA1c <7% and weight loss >3 kg vs. PBO without evidence that the glucose-lowering effects of EFPEG were dependent on weight loss. Disclosure J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. C. Morales: Other Relationship; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. U. Wendisch: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Eli Lilly and Company, Kowa Pharmaceutical Europe Co. Ltd., Lexicon Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S. Stock/Shareholder; Self; Novartis AG, Novo Nordisk A/S. G.E. Dailey: Research Support; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi US. Speaker's Bureau; Self; Sanofi US. M.E. Trautmann: Consultant; Self; CeQur Corporation, Hanmi Pharm. Co., Ltd., Intarcia Therapeutics, Inc., Oramed Pharmaceuticals, ProSciento, Servier. Stock/Shareholder; Self; Lilly Diabetes. M. Hompesch: Stock/Shareholder; Self; ProSciento. I. Choi: Employee; Self; Hanmi Pharm. Co., Ltd. J. Kang: Employee; Self; Hanmi Pharm. Co., Ltd. J.A. Stewart: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. I. Ogbaa: Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. Other Relationship; Self; Sanofi. C.H. Sorli: Employee; Self; Sanofi. K. Yoon: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc. Speaker’s Bureau; Self; Takeda Pharmaceutical Company Limited. Funding Hanmi Pharmaceutical, Co., Ltd.; Sanofi
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