121-OR: Safety, Tolerability, and Metabolic Effects of Once-Weekly GL0034 (Utreglutide) in Individuals with Obesity—A Multiple Ascending Dose Study

Introduction cohort 1); or increasing doses (680, 900, 1520, 2000 µg; cohort 2) or placebo, once weekly for four weeks. Safety, tolerability and key metabolic parameters were assessed. Results: Most common adverse events (AE) were gastrointestinal (GI) with dose-dependent nausea, decreased appetite and vomiting. One individual with a GI related serious AE rapidly recovered upon treatment with intravenous rehydration. On Day 23, reduction was observed in all parameters from baseline (BL) with significant reductions in glucose area under the curve and HbA1c in both groups. In cohorts 1 Sun Pharmaceutical Industries Ltd. A. Garcia-Ocana: Consultant; Sun Pharmaceutical Industries Ltd. G.A. Rutter: Advisory Panel; Sun Pharmaceutical Industries Ltd. R.E. Pratley: Other Relationship; Bayer AG, Dompé, Endogenex, Inc., Gasherbrum Bio, Inc., Hengrui (USA) Ltd., Intas Pharmaceuticals Ltd., Eli Lilly and Company, Merck Sharp AbbVie Inc., AstraZeneca. Other Relationship; Bayer HealthCare Pharmaceuticals, Inc., Biomea Fusion, Carmot Therapeutics, Inc., Corcept Therapeutics, Fractyl Health, Inc., Genprex. Consultant; Getz Pharma. Other Relationship; Lilly USA LLC, Sanofi. Consultant; Scholar Rock, Inc. B. Thorens: Advisory Panel; Sun Pharmaceutical Industries Ltd. T. Vilsbøll: Consultant; AstraZeneca. Advisory Panel; Boehringer-Ingelheim. Speaker's Bureau; Mundipharma. Advisory Panel; Novo Nordisk, Lilly Diabetes, Sanofi. Speaker's Bureau; Bayer Inc., Gilead Sciences, Inc. Advisory Panel; Sun Pharmaceutical Industries Ltd. Research Support; Lilly Diabetes.