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On September 18, 2024, we reported on research presented at the 60th Annual Meeting of the European Association for the Study of Diabetes 2024, held in Madrid, Spain, from September 10-13, 2024.
The study
Data was presented from the first-in-human study of amycretin, a first-of-its-kind, protein-based unimolecular amylin and glucagon-like peptide-1 (GLP-1) receptor agonist coagonist. The novel antiobesity medication is being explored as a once-daily oral alternative to subcutaneous injectable antiobesity medications in persons with overweight or obesity.
In the single-center, placebo-controlled, double-blinded study, participants were randomly assigned to receive once-daily oral amycretin (n=95) or placebo (n=29) for up to 12 weeks. The amycretin arm consisted of 3 dose parts: single-ascending dose (increasing from 1 mg to 25 mg), 10-day multiple-ascending doses (3 mg to 12 mg), and 12-week multiple-ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2x50 mg).
The findings
Participants who received amycretin 50 mg had a 10.4% reduction in body weight, on average, between baseline and week 12, while those who received amycretin 2x50 mg (the maximum dose tested) had a mean body weight reduction of 13.1%. In comparison, persons in the placebo group had a 1.1% reduction in body weight during the same period (P < .001 for both doses).
With regards to the study’s primary endpoint, treatment-emergent adverse events (AEs), researchers did not observe any significant safety issues related to amycretin. The majority of AEs reported were mild-to-moderate in severity and related to gastrointestinal discomfort (ie, nausea, vomiting) and decreased appetite.
Authors' comment
“The results underscore the promising potential of amycretin as an anti-obesity medication and may pave the way for a novel patient-centered weight-management option."
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