Safety, efficacy and pharmacokinetics of repeat subcutaneous dosing of avexitide (exendin 9‐39) for treatment of post‐bariatric hypoglycemia
Diabetes, Obesity and Metabolism Apr 10, 2020
Tan M, et al. - In this Phase 2, multiple‐ascending‐dose study conducted at Stanford University, researchers assessed the safety, effectiveness, and pharmacokinetics of repeat dosing of two formulations of subcutaneous (SC) avexitide (exendin 9–39) in individuals with post‐bariatric hypoglycemia (PBH). For this investigation, 19 women with PBH had a baseline oral glucose tolerance test with metabolic and symptomatic assessments. Fourteen candidates were then sequentially assigned to receive 1 of 4 ascending dose levels of twice daily (BID) lyophilized avexitide by SC injection for 3 days. Based on safety, efficacy and tolerability, 5 additional candidates received a novel liquid formulation of avexitide by SC injection at a fixed dose of 30 mg BID for 3 days. According to results, BID administration of SC avexitide effectively raised glucose nadir in patients with PBH and prevented severe hypoglycemia needing rescue intervention. Findings suggested that avexitide may be a viable therapy for PBH.
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