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Novo plans to address the requests in the warning letter expeditiously and holistically, Anna Windle, the pharmas head of clinical development, medical and regulatory affairs, said in a statement on Tuesday

Additionally, agents capable of positively modulating more than one peptide hormone receptor simultaneously, such as tirzepatide or the recently characterised GL-0001 peptide, could offer an even more exciting avenue to help realise the potential of gut-derived hormones to treat bone disease

Research has identified multiple pathways through which semaglutide impairs normal stomach function: Direct inhibition of gastric motility through vagus nerve modulation Disruption of gastric pacemaker cells that coordinate stomach contractions Impaired gastric accommodation in the fundus and body regions Antral hypomotility preventing proper food grinding and propulsion Dysregulation of pyloric sphincter relaxation blocking stomach emptying Alterations in small intestinal motility affecting the entire digestive process Clinical data reveals that up to 75% of patients with normal gastric emptying before receiving GLP-1 agonists developed delayed gastric emptying after treatment initiation, with some studies showing 30% experiencing severe delays qualifying as gastroparesis