Metsera Inc(US:MTSR) Globenewswire·2025-06-09 11:00Core Insights - Metsera, Inc. announced positive topline data from the Phase 1 clinical trial of MET-233i, showing up to 8.4% mean placebo-subtracted weight loss at Day 36, supporting its potential as a once-monthly monotherapy and in combination with MET-097i [1][2][4] - The trial demonstrated favorable tolerability with no safety signals, indicating a promising profile for MET-233i as a potential best-in-class amylin analog [2][4] Group 1: Clinical Trial Results - The Phase 1 trial was randomized, placebo-controlled, and double-blind, involving 80 participants with overweight or obesity without type 2 diabetes, evaluating doses from 0.15 mg to 2.4 mg [2][3] - Body weight loss was dose-dependent, with a mean of 8.4% at Day 36 after five weekly doses of 1.2 mg, and individual responses reached as high as 10.2% [4] - The pharmacokinetics showed a 19-day half-life, supporting once-monthly dosing and indicating the most durable profile among known amylin analogs [4] Group 2: Safety and Tolerability - Gastrointestinal adverse events were mild and primarily occurred in the first week, suggesting rapid tolerance development [4] - Anticipated starting doses of 0.15 mg and 0.3 mg showed tolerability results comparable to placebo [4] - No severe or serious adverse events were reported during the trial [4] Group 3: Future Developments - Metsera plans to advance MET-233i as a monotherapy and in combination with MET-097i, with topline data from an ultra-long acting GIP receptor agonist, MET-034i, expected in late 2025 [5][12] - The company is pursuing regulatory approval for the combination of MET-233i and MET-097i via the FDA biologic pathway [7] Group 4: Technology and Platform - MET-233i is developed using Metsera's HALO™ platform, which enhances peptide stability and allows for a longer half-life, potentially enabling monthly dosing [8] - The HALO™ platform is designed to improve tolerability and scalability of peptide therapies [8]