Once-weekly (QW), subcutaneous efpeglenatide (efpeg) is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA) in development for T2D. Efpeg reduced blood glucose and body weight (BW) in Phase 2 trials in patients with T2D (EXCEED 203) and patients with obesity without diabetes (BALANCE 205; Table). To assess whether these effects were associated with benefits on lipids, the effects of efpeg QW on total cholesterol [TC], high [HDL-C], low [LDL-C], and very low density lipoprotein cholesterol [VLDL-C] and triglycerides [TG] were assessed in patients from these Phase 2 trials (VLDL-C measured in BALANCE 2only). In the 12-week EXCEED 203 study in patients with T2D, efpeg QW led to significant (p<0.05) reductions vs. placebo in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and BW (3-mg and 4-mg doses), and significant reductions in LDL-C and TG (4 mg only; Table). In the 20-week BALANCE 2study in nondiabetic patients with obesity, efpeg QW led to significant reductions vs. placebo in BW, HbA1c, FPG, TC, VLDL-C, TG (4-mg and 6-mg doses) and LDL-C and HDL-C (6 mg only). The safety profile of efpeg in both trials was consistent with GLP-1 RAs. These findings suggest that BW loss and glycemic effects with efpeg are accompanied by significant benefits on lipid profiles, providing an overall improvement in the abnormal metabolic state associated with T2D.
R.E. Pratley: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Pfizer Inc., Sanofi-Aventis, Takeda Development Center Americas, Inc. J. Kang: Employee; Self; Hanmi Pharmaceutical. I. Choi: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. M.E. Trautmann: Consultant; Self; ProSciento. Stock/Shareholder; Self; Eli Lilly and Company. Consultant; Self; Hanmi Pharmaceutical, CeQur Corporation, Intarcia Therapeutics, Inc., Servier. M. Hompesch: Other Relationship; Self; Hanmi Pharmaceutical. K. Yoon: None. C.H. Sorli: Employee; Self; Sanofi.