Metsera, Inc. (NASDAQ: MTSR) has released positive topline data from two phase 2b trials of its first-in-class ultra-long acting GLP-1 RA candidate, Met-097i. In the Vesper-1 trial, Met-097i demonstrated a mean placebo-subtracted weight loss of up to 14.1% after 28 weekly doses. The study also revealed potential for best-in-class tolerability, with minimal diarrhea signal, 13% nausea, and 11% vomiting.
The Vesper-3 trial also showed promising results, with Met-097i demonstrating potentially class-leading tolerability at the highest evaluated dose, with minimal diarrhea signal and a risk difference from placebo of 13% for nausea and 11% for vomiting after two titration steps.
The trials included populations with overweight or obesity without type 2 diabetes, with approximately two-thirds female participants. Vesper-1 had a total study discontinuation rate of 2.9%, with only two of 239 participants discontinuing treatment due to adverse events.
The results from these trials have led Metsera to confirm the initiation of a global phase 3 program in late 2025. Additionally, the company is conducting additional phase 2b trials to further characterize the monthly profile of Met-097i for long-term maintenance and in populations with type 2 diabetes mellitus.
Met-097i is also the foundational incretin backbone of four additional clinical programs, including a first-in-category monthly multi-nush combination and an oral form of Met-097, among others.
Met-097i is a fully biased, ultra-long acting, subcutaneously injectable monthly GLP-1 RA engineered for class-leading potency, durability, and combinability with other Metsera nush analogs.
Metsera's novel peptide stabilization and lipidation platform, Halo™, enables peptides to bind simultaneously to albumin and a drug target, facilitating a half-life approaching that of albumin and exceeding that of other nush peptides.
Metsera, Inc. is a clinical-stage biopharmaceutical company focused on accelerating the next generation of medicines for obesity and metabolic diseases, and was founded in 2022 and is based in New York City.
The market has reacted to these announcements by moving the company's shares -0.29% to a price of $52.10. Check out the company's full 8-K submission here.