Novo Nordisk's Novel Dual-Action Amycretin Shows ~24% Weight Loss at 36 Weeks in Phase 1b/2a Trial, Data Published in The Lancet

June 26,Novo Nordisk（Novo Nordisk）Announced that the clinical trial data of subcutaneous injection of amycretin was reported at the 85th Scientific Sessions of the American Diabetes Association (ADA) held in Chicago, USA.Two projects aimed at evaluatingSubcutaneous Injection and Oral Amycretin in Overweight or Obese PatientsThe full results of the clinical trial on its safety, tolerability, and weight-loss potential were simultaneously published in the medical journal The Lancet.Amycretin is a single molecule with dual agonistic effects on GLP-1 and amylin receptors.

The published and reported results of the Phase 1b/2a clinical trial for once-weekly subcutaneous amycretin showed that, compared with placebo, all dose groups of subjects receiving amycretin demonstrated greater weight loss. The data reported at the ADA meeting came from two parts of the trial: escalating doses (amycretin 60 mg) and escalating and maintenance doses (amycretin 20 mg, 5 mg, and 1.25 mg).At the end of treatment (20-36 weeks), weight loss had not plateaued in any dose group, suggesting that extending the treatment period may lead to further weight reduction.

Once-weekly subcutaneous injectionamycretinEstimated mean change in body weight from baseline after treatment: 

Once-weekly subcutaneous injection of amycretin showed good tolerability when dose-escalated to 60 mg, with a safety profile consistent with other GLP-1 and amylin receptor agonists.Adverse events during treatment increased in a dose-dependent manner, and most were gastrointestinal adverse events. The incidence and characteristics were similar to the early study results of GLP-1 receptor/gastric inhibitory peptide (GIP) receptor and amylin receptor agonists.Most adverse events that occurred during the treatment were mild to moderate and resolved by the end of the trial.Most subjects who discontinued the study did so for reasons other than adverse events that occurred during the treatment period.

Published Phase 1 clinical trial data for once-daily oral amycretin showed a significant reduction in body weight among subjects receiving amycretin compared to placebo.After 12 weeks of treatment with once-daily 50 mg amycretin and twice-daily 50 mg amycretin, the average weight loss of participants was 10.4% and 13.1%, respectively, compared to 1.2% in the placebo group.。No significant cessation of weight loss was observed within 12 weeks in either group of subjects receiving amycretin treatment.

Once-daily oral amycretin demonstrated a favorable safety profile and was well-tolerated at all tested doses, with adverse events consistent with the expected characteristics related to GLP-1 and amylin receptors during treatment.All reported treatment-emergent adverse events were dose-related, mild to moderate in severity, and mostly gastrointestinal adverse events. No new safety signals were identified during the study.