Metsera has released new data showing significant weight loss results from its investigational GLP-1 therapy, MET-097i. After 12 weeks of treatment, patients lost an average of 11.3% of their body weight. Some patients in the highest dose group even saw losses of up to 20%. The results were shared in a Phase IIa study on Tuesday, marking another milestone for the company.
The data shows that MET-097i continues to produce strong weight reduction without showing any signs of a plateau effect, suggesting that longer treatment could lead to even greater weight loss, according to Metsera. The company emphasized that all participants, regardless of the dose, achieved “clinically meaningful and statistically significant” weight loss after 12 weeks.
Steve Marso, Chief Medical Officer of Metsera, described the findings as “powerful,” and reiterated the company’s belief that MET-097i could become a leading ultra-long-acting GLP-1 receptor agonist (GLP-1RA) in weight management.
Along with the promising weight loss data, Metsera also highlighted the favorable safety profile of MET-097i. Over the 12-week treatment period, side effects were mild, moderate, and transient, with no serious adverse events reported. Even in the highest dose group, which received escalating doses of the drug, the treatment remained well-tolerated.
MET-097i’s pharmacological exposure also increased over the 12-week period, with concentrations rising by four times in patients who received the drug without dose adjustments. Metsera explained that this prolonged exposure is due to the drug’s long half-life of 15 to 16 days, which may support a monthly dosing schedule.
The latest results follow an earlier Phase I study in which MET-097i showed a 7.5% weight loss within 36 days, a result that Metsera claimed was competitive with other GLP-1 treatments, both approved and experimental. Following those findings, Metsera partnered with Amneal Pharmaceuticals to help advance the drug’s development.
Metsera, which emerged from stealth mode in April 2024, has rapidly gained attention, raising $290 million in financing followed by an additional $215 million in November. The company has also earned a spot in BioSpace’s “NextGen Class of 2025,” a list of biotech startups to watch.
Looking ahead, Metsera is moving forward with a Phase IIb trial of MET-097i, which has already enrolled 239 participants with obesity or overweight. Topline data from this study are expected by mid-2025. The company also plans to launch additional studies this year, including one to explore the potential for monthly dosing of the drug in obesity and type 2 diabetes.
Metsera has announced that if these trials are successful, it plans to move swiftly into Phase III trials.
