Novo Nordisk successfully completes phase 1b/2a trial with subcutaneous amycretin in people with overweight or obesity

Clinical Trial Results - Novo Nordisk announced topline results from a phase 1b/2a clinical trial for amycretin, a unimolecular GLP-1 and amylin receptor agonist intended for once-weekly subcutaneous administration [1] - The trial involved 125 people with overweight or obesity and investigated safety, tolerability, pharmacokinetics, and proof-of-concept over up to 36 weeks of treatment [2] - The primary endpoint was treatment-emergent adverse events, with the safety profile consistent with incretin-based therapies and most adverse events being mild to moderate gastrointestinal issues [3] Efficacy Data - Participants treated with amycretin achieved estimated body weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks), and 22.0% on 20mg (36 weeks) from a mean baseline body weight of 92.7 kg [4] - Placebo-treated participants experienced estimated body weight gains of 1.9%, 2.3%, and 2.0% respectively [4] Company Commentary - Novo Nordisk expressed encouragement with the trial results, highlighting the weight-lowering potential of amycretin and its alignment with previous oral formulation results [5] - The company plans further clinical development of amycretin for adults with overweight or obesity [5] Product Background - Amycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development for both oral and subcutaneous administration, targeting overweight, obesity, and type 2 diabetes [6] Trial Design - The phase 1b/2a trial was a randomised, placebo-controlled, double-blinded study conducted in five parts, exploring pharmacokinetics, safety, tolerability, and proof-of-concept over up to 36 weeks with dose escalation [7] Company Overview - Novo Nordisk is a global healthcare company founded in 1923, headquartered in Denmark, with a focus on defeating serious chronic diseases through scientific breakthroughs and expanding access to medicines [8] - The company employs approximately 72,000 people in 80 countries and markets products in around 170 countries [8]