Once-weekly (QW), subcutaneous efpeglenatide (efpeg) is a long-acting GLP-1 RA being developed to improve glycemic control in T2D. In the 20-week BALANCE 205 study (NCT02075281), all doses of efpeg led to significant reductions in body weight (BW) vs. placebo (PBO) in patients with obesity without diabetes (p<0.0001; primary endpoint). This exploratory analysis investigated the effects of efpeg on glycemic, BW, BMI, waist circumference (WC) and cholesterol parameters in patients from BALANCE with prediabetes (HbA1c 5.7−6.4% or FPG 100−125 mg/dL) at baseline (n=140/295). At study end, percentages of patients with normoglycemia (i.e., no longer prediabetic) were higher with efpeg (4 mg QW, 64.3%; 6 mg QW, 46.2%; 6 mg once every 2 weeks [Q2W], 40.6%; 8 mg Q2W, 41.7%; pooled efpeg, 48.2%) than with PBO (10.0%; Table). All efpeg doses led to significant reductions vs. PBO in BW and HbA1c (p<0.0001 for all comparisons; −6.6 kg and −0.4%, respectively for pooled group), BMI, total cholesterol, FPG and WC (p<0.05 for all), except the 4 mg QW dose for WC. Adverse events (AEs) mirrored those known for GLP-1 RAs, with higher rates of gastrointestinal AEs vs. PBO, with no incidences of severe hypoglycemia.
In conclusion, treatment with efpeg led to significant improvements vs. PBO in HbA1c, BW, BMI, FPG, WC and cholesterol, and greater proportions of patients achieving normoglycemia, in patients with obesity and prediabetes.
R.E. Pratley: Consultant; Self; Sanofi US. Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Janssen Global Services, LLC., Janssen Research & Development, Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk Inc., Pfizer Inc., Sanofi, Takeda Development Center Americas, Inc. S. Jacob: Advisory Panel; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novartis AG, Novo Nordisk A/S, Roche Diabetes Care, Sanofi. J. Kang: Employee; Self; Hanmi Pharm. Co., Ltd. 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. O. Han: None. 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.
Hanmi Pharmaceutical, Co., Ltd.; Sanofi