Globenewswire·2025-09-29 20:01Core Insights - Metsera, Inc. announced positive topline data from two Phase 2b trials, VESPER-1 and VESPER-3, for its drug MET-097i, showing a placebo-subtracted mean weight loss of up to 14.1% after 28 weeks with no plateau observed [1][3][7] - The drug demonstrated potentially best-in-class tolerability, with minimal diarrhea signals and low rates of nausea (13%) and vomiting (11%) [1][5][6] - High retention rates were noted in both trials, with only 2.9% discontinuation in VESPER-1, supporting the drug's advancement to Phase 3 trials expected to start in late 2025 [2][7] Trial Details - VESPER-1 involved 239 participants with doses ranging from 0.4 mg to 1.2 mg administered weekly over 28 weeks, while VESPER-3 included 268 subjects evaluating multiple monthly doses [2][3] - In VESPER-1, the highest dose of 1.2 mg resulted in a mean weight loss of 14.1%, with individual responses reaching up to 26.5% [3][4] - The ongoing VESPER-3 trial is designed to assess the efficacy and tolerability of MET-097i with a pre-specified interim analysis after 12 weeks [2][8] Efficacy and Tolerability - The drug's efficacy was dose-dependent, with significant weight loss observed at higher doses [3][4] - Tolerability results indicated a placebo-like frequency of gastrointestinal adverse events, with nausea and vomiting risk differences from placebo being 13% and 11%, respectively [5][6] - The tolerability profile of MET-097i at higher doses without titration was comparable to existing agents that require prolonged titration [5][6] Future Development - Metsera plans to initiate a global Phase 3 program in late 2025 based on the positive topline data [7] - Additional Phase 2b trials are ongoing to explore the long-term maintenance profile of MET-097i and its effects in populations with type 2 diabetes [7][8] - MET-097i is positioned as the foundational incretin backbone for multiple clinical programs, indicating a robust pipeline for Metsera [7][9] Technology and Platform - MET-097i is a fully biased, ultra-long acting GLP-1 receptor agonist designed for monthly dosing, showcasing class-leading potency and durability [9][10] - The HALO™ peptide stabilization and lipidation platform enhances the drug's half-life, potentially improving tolerability and scalability [10] Company Overview - Metsera, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation medicines for obesity and metabolic diseases [11] - The company aims to address multiple therapeutic targets with a broad portfolio of therapies, including oral and injectable options [11]