Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial.

What was studied?

A first-in-human, randomized, double-blind, placebo-controlled trial evaluated oral amycretin, a combined GLP-1 and amylin receptor agonist.

What changed?

Across study parts, 89 participants reported 364 adverse events, all mild or moderate. Events became more frequent with increasing dose; 180 were gastrointestinal. No deaths occurred, and blood exposure was consistent with dose proportionality. The abstract reports no numerical weight-loss result.

Who was studied?

The trial enrolled 144 adults aged 18–55 with overweight or obesity at a single research center.

Studied exposure

Oral dosing versus placebo comprised single doses of 1, 3, 6, 12, 18 or 25 mg; 3, 6 or 12 mg once daily for 10 days; and 12-week daily titration from 3 to 50 mg, 6 to two 50 mg tablets, or 3 to two 25 mg tablets.

What remains uncertain?

Study limitations were not stated in the abstract. Methodological quality has not been appraised.

Abstract summarized · Quality not appraised