Metsera has linked its GLP-1 drug candidate to weight loss of up to 11.3% after 12 weeks, encouraging the biotech to use some of its $215 million war chest to assess monthly dosing of the injectable therapy.
The biotech, which was founded by Population Health Partners and Arch Venture Partners, has ceded a big head start to Eli Lilly and Novo Nordisk. The Big Pharmas have carved up the injectable weight loss market between them over the past year or so, generating blockbuster sales in the process. But Metsera has identified an opportunity for a long-acting rival to Wegovy and Zepbound.
MET-097i is the biotech’s play for that opportunity. Metsera tested the molecule in a phase 2a trial that enrolled 100 patients to receive one of five MET-097i regimens, plus a further 20 people to take placebo.
After 12 weeks of weekly dosing, Metsera saw mean placebo-adjusted weight loss of up to 11.3%. The highest weight loss was seen in patients who received a fixed dose of MET-097i. The fifth cohort received escalating doses, climbing to the top, 1.2-mg, dose over eight weeks, and had a mean placebo-adjusted weight loss of 6.3%.
Comparing data across GLP-1 trials is complicated by differing approaches to dose titration and criteria for enrollment—Metsera’s trial excluded patients with Type 2 diabetes, for example—but the results are at least in the same ballpark as Wegovy and Zepbound.
While weight loss was lower when the dose was titrated, Metsera said the tolerability was “compelling” in the escalation cohort. The biotech reported one case of mild, transient nausea and two cases of mild, transient vomiting in 20 patients who received rising doses. Metsera said MET-097i was generally well tolerated in all dose groups, with gastrointestinal adverse events being mild or moderate and short-lived.
Patients switched to a two- or fourfold higher dose at Week 13 to assess the tolerability of moving to a potential monthly regimen. Metsera said the switch was well tolerated. The biotech plans to start a new trial to confirm the potential for monthly dosing this year. Maintenance doses of Wegovy and Zepbound are given weekly.
The monthly dosing trial is part of a broad slate of active and planned MET-097i studies. A phase 2b trial in people with obesity or overweight is fully enrolled and on track to deliver data around the middle of 2025. Metsera’s to-do list includes the initiation of additional trials of MET-097i in people with obesity, who are overweight and who have Type 2 diabetes. The roster of studies is intended to support a move into phase 3.
Metsera secured funding to support its plans last November, when Wellington Management and Venrock Healthcare Capital Partners led a $215 million series B investment. The money added to the $322 million Metsera had raised up to that date.