Novo Nordisk has commenced the AMAZE 9 trial, the first Phase III study of oral zenagamtide, a single-molecule dual agonist of GLP-1 and amylin receptors (GLP-1R and AMYR), dosed once daily as a tablet. The multicentre study will enrol 950 adults with obesity, comparing five oral dose levels plus lifestyle intervention against placebo over 76 weeks, with percentage body weight change as the primary endpoint.
Prior Phase I/II subcutaneous data showed 24.3% weight reduction at 36 weeks versus 1.1% for placebo, establishing zenagamtide among the most potent investigational agents in its class.
Among global amylin or AMYR-targeted candidates in late-stage development – pramlintide, cagrisema, cagrilintide, eloralintide, and zenagamtide – Novo Nordisk's asset is the only one with both injectable weekly and oral daily formulations in active clinical programmes. If successful, the oral tablet could combine near-surgical efficacy with consumer-grade convenience, extending Novo Nordisk's leadership beyond semaglutide and reshaping competitive dynamics in the oral obesity therapeutics segment where Pfizer's danuglipron and Hengrui's safiglipron also compete.

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