Metsera reports ‘positive’ Phase 2b results for GLP-1 RA candidate MET-097i

Metsera (MTSR) announced positive topline data from VESPER-1 and positive data from a planned interim analysis for tolerability of VESPER-3 – two Phase 2b trials of MET-097i, a first-in-class fully biased, ultra-long acting GLP-1 receptor agonist, or RA, with potential for monthly dosing. In VESPER-1, MET-097i demonstrated mean placebo-subtracted weight loss of up to 14.1% after 28 weekly doses. MET-097i demonstrated potentially class-leading tolerability in both trials. At the highest evaluated dose in VESPER-3, there was minimal diarrhea signal and a risk difference from placebo of 13% nausea and 11% vomiting at 12 weeks after two titration steps. The randomized, placebo-controlled, double-blind VESPER-1 and VESPER-3 Phase 2b trials include populations with overweight or obesity without type 2 diabetes. In VESPER-1, MET-097i was evaluated in 239 participants with doses ranging from 0.4 mg to 1.2 mg, administered once weekly over 28 weeks without titration, with an ongoing study extension that includes less frequent dosing options. VESPER-3 is an ongoing trial with 268 subjects enrolled, designed to evaluate the efficacy and tolerability of multiple monthly doses of MET-097i for 28 weeks. It includes a pre-specified interim analysis after 12 weekly doses to assess the tolerability of various dose escalation strategies. The study populations are representative of a typical Phase 3 chronic weight management trial, with an approximate BMI in both studies of 36 and approximately two thirds female participants.