Amid a flurry of weight loss readouts, a fresh-on-the-scene startup has come out with Phase I results showing weight loss at day 36 on par with or better than competitors, with few gastrointestinal side effects.
Five months after launching, Metsera is making waves with Phase I results for a long-acting GLP-1 injectable showing a 7.5% reduction in body weight at day 36. The biotech said the results were as good as or better than approved or other similar clinical-stage GLP-1 compounds out there now.
Notably, the trial did not involve titration—a period where a patient adjusts to the dose by slowly ramping up—which has been necessary for approved weight loss medicines and most in the clinic to ease common gastrointestinal side effects. Despite this, Metsera reported few such incidents among trial participants, and these were relatively mild.
Metsera plans to move quickly to advance MET-097 based on the early-stage results, with a Phase IIb set to kick off in the fourth quarter and data expected in the first half of 2025.
MET-097 is a long-acting injectable GLP-1 receptor agonist. The Phase I trial involved 125 adults who are healthy, non-diabetic and either overweight or obese. The participants received either single doses ranging from 0.16 mg to 1.6 mg or five weekly doses of 0.2 mg to 1.2 mg.
At the 1.2 mg weekly dose, participants achieved 7.5% change in body weight compared to baseline at day 36, one week after the final dose. Metsera said this was consistent with or better than marketed products, which include Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, and other GLP-1/GIP compounds in clinical development.
Cumulative weight loss in this dose group was 8.1% at day 57, four weeks after the last dose, which shows a durable effect from the therapy, Metsera said.
As for safety, gastrointestinal adverse events were generally mild and dose-related. There were no severe treatment-emergent adverse events observed and no treatment-related discontinuations.
Metsera Competes in Crowded Next-Gen Weight Loss Space
Metsera’s results land amid a flurry of data readouts from next-gen candidates under development by small biotech peers and Big Pharma rivals. Terns Pharmaceuticals announced earlier this month that an investigational GLP-1 pill led to 4.9% weight loss after just 28 days. Meanwhile Novo Nordisk’s cannabinoid receptor 1 (CB1) inverse agonist cut weight by 15 lbs after 16 weeks of treatment, but participants reported neuropsychiatric side effects.
Another Novo entrant, amycretin, achieved 13% weight loss at week 12. And trial participants taking Roche’s oral GLP-1 receptor agonist rapidly lost 7.3% of their body weight at four weeks but experienced challenging side effects.
Metsera is one of the newest companies on the scene, having launched in April with $290 million in financing backed by Population Health Partners and ARCH Venture Partners. The company already had a GLP-1 portfolio in hand, including MET-097, whose Phase I trial was already underway when the company broke cover.
“Metsera was purpose-built over the last two years to get ahead of the innovation curve in one of the largest and fastest growing markets in the history of biopharma,” Metsera CEO Clive Meanwell said in an April statement.
