Metsera, Inc. (NASDAQ:MTSR) on Tuesday released topline data from VESPER-1 and data from a planned interim analysis for tolerability of VESPER-3 – two Phase 2b trials of MET-097i with potential for monthly dosing.
In VESPER-1, MET-097i demonstrated a mean placebo-subtracted weight loss of up to 14.1% after 28 weekly doses.
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Body weight loss in VESPER-1 was dose-dependent, ranging up to a placebo-subtracted mean of 14.1% at 28 weeks at the 1.2 mg dose level, with individual responses as high as 26.5%.
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An exploratory analysis at the end of the weekly dosing phase of the study extension of VESPER-1 at 36 weeks demonstrated substantial continued weight loss, highlighting that no plateau had been reached.
As VESPER-3 is ongoing, weight loss is not reported.
MET-097i demonstrated placebo-like tolerability at a starting dose of 0.4 mg across multiple arms in both trials, and the potential for class-leading tolerability with one- or two-step titration.
In the VESPER-3 trial arm that titrated from 0.4 mg to 0.8 mg to 1.2 mg over 12 weeks, there was minimal diarrhea signal, a 13% risk difference from placebo for nausea, and 11% for vomiting.
The tolerability profile of higher doses of MET-097i without titration in VESPER-1 was similar to that reported for approved agents that use prolonged titration regimens, with dose-dependent risk difference for nausea ranging from 4% to 23%, for vomiting from 4% to 15%, and for diarrhea from 0% to 13%.
VESPER-1 had a 2.9% total study discontinuation, with two of 239 participants discontinuing treatment due to adverse events. VESPER-3 is ongoing, with high participant retention to date.
Metsera says it is on track to initiate a global Phase 3 program in late 2025.
Additional Phase 2b trials are ongoing to characterize the monthly profile of MET-097i for long-term maintenance and in populations with type 2 diabetes mellitus. Topline data expected in early 2026
VESPER-3 is ongoing to assess monthly dosing of MET-097i, with topline data at the primary endpoint at 28 weeks expected by year-end 2025 or in early 2026.
The company said, “…dose and exposure-response models informed by these trial results give Metsera a high degree of confidence that doses of MET-097i could match or exceed the performance of tirzepatide 15 mg at steady state.”
MTSR Price Action: Metsera stock is up 0.51% at $52.37 at publication on Tuesday.
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