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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.