Months after posting weight loss of 7.5% at 36 days for patients taking MET-097i, Metsera releases mid-stage results of just over 11% average body weight reduction at 12 weeks, with no plateau and a promising safety profile.
Just over three months after it commanded the industry’s attention with impressive Phase I data, Metsera is back with more promising findings for its investigational subcutaneous GLP-1 therapy MET-097i, which in a Phase IIa readout on Tuesday showed strong weight reduction and an encouraging tolerability profile.
After 12 weekly doses, patients on MET-097i lost 11.3% of their body weight on average, as compared with placebo. In the 1.2-mg dose group, individual responses reached as high as 20% in some cases. According to the biotech, all patients treated with MET-097i, regardless of dose, achieved “clinically meaningful and statistically significant weight loss” after 12 weeks.
Notably, Metsera had not yet detected a plateau effect at the time of the readout, indicating that MET-097i could elicit even greater weight-loss with longer dosing, the company said.
In a statement, Metsera CMO Steve Marso called Tuesday’s weight-loss findings “powerful,” noting that they “strengthen our view of MET-097i as the potential first ultra-long acting GLP-1RA.”
Metsera also touted the “attractive tolerability profile” of MET-097i, which over 12 weeks of follow-up was found to be generally safe across all dose levels. Gastrointestinal side effects were all mild, moderate and transient. Even in the highest dose cohort, which were given escalating titrations of the drug, MET-097i’s tolerability profile remained “compelling,” according to Metsera.
Additionally, pharmacological exposure to MET-097i accumulated over the study’s 12-week period, hitting a four-fold increase in concentration in patients who were dosed without titration. According to Metsera, this prolonged exposure to the drug is driven by its 15- to 16-day half-life and ultra-long-acting profile, which in turn could support monthly dosing.
Marso said on Tuesday that the biotech is “excited” about the tolerability and dosing profile of MET-097i. The new data come less than four months since MET-097i first stunned the industry with its 7.5% weight-loss at 36 days. At the time, Metsera claimed that these Phase I findings were on par or better than other GLP-1 compounds—both approved and experimental. A few weeks later, the biotech entered into a supply-focused partnership with Amneal Pharmaceuticals, likely to support MET-097i’s development and commercial roll-out.
All this activity comes in the very first year for Metsera, which just emerged from stealth in April 2024 with $290 million in financing. Seven months later, the company raised another $215 million. These developments helped earned Metsera a spot in BioSpace’s NextGen Class of 2025, announced today with a total of 25 biotech startups to watch. In addition to Metsera, obesity-focused OrsoBio also made the list, as more and more companies dive into the exploding weight loss space.
With the latest results, Metsera is full speed ahead. The company is also running a parallel Phase IIb trial of MET-097i, which has been fully enrolled with 239 participants with obesity or overweight. Topline data from this study are expected in mid-2025. Metsera is also planning to launch other studies of MET-097i in obesity and type 2 diabetes this year, including one that will explore the potential of a monthly dosing regimen for the drug.
“If these trials are successful, Metsera plans to initiate Phase III trials shortly thereafter,” the company wrote in its Tuesday release.
