Rosenstock, JulioSorli, Christopher HTrautmann, Michael EMorales, CristóbalWendisch, UlrichDailey, GeorgeHompesch, MarcusChoi, In YoungKang, JahoonStewart, JohnYoon, Kun-Ho2023-01-252023-01-252019-07-18http://hdl.handle.net/10668/14260To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy). EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis). Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36). The primary efficacy end point was change in HbA1c from baseline to week 13. From a baseline HbA1c of 7.7-8.0% (61.0-63.9 mmol/mol), all efpeglenatide doses ≥1 mg significantly reduced HbA1c versus placebo (placebo-adjusted least squares [LS] mean changes 0.6-1.2%, P Efpeglenatide once weekly led to significant reductions in HbA1c and weight, with a safety profile consistent with the GLP-1 RA class in patients with early T2D mostly on metformin monotherapy.enAdultAgedBlood GlucoseBody WeightDiabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleGlucagon-Like Peptide-1 ReceptorGlycated HemoglobinHumansHypoglycemic AgentsLiraglutideMaleMetforminMiddle AgedProlineTreatment Outcomeresearch article3132044610.2337/dc18-26481935-5548