The randomised, double-blind, placebo-controlled trial sought five cohorts of 120 obese patients who are not type-2 diabetic. Credit: shutterstock / Alones

New York obesity healthcare firm, Metsera, has unveiled positive topline results from its Phase IIa trial of its glucagon-like peptide-1 receptor agonist (GLP-1RA), MET-097i, as it plans to go up against industry heavyweights such as Novo Nordisk and Eli Lilly, boasting potential once-monthly dosing compared to competitors more frequent regimen.

The company has today (7 January) confirmed that its 12-week Phase IIa clinical trial of MET-097i saw the GLP-1RA was well tolerated with a mean reduction in body weight of 11.3% over the period, adjusted for placebo, with some responses as high as a 20% reduction in weight.

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Additionally, the company claims that the trials never saw a weight loss plateau indicating a potential for further weight loss with sustained use, with the trial meeting its primary endpoint with five out of five cohorts all seeing some form of clinically meaningful and statistically significant weight loss after 12 weeks.

The randomised, double-blind, placebo-controlled trial enrolled five cohorts of 120 obese patients who are not type 2 diabetic. In all five cohorts, 20 patients received the active drug while four patients were given a placebo. Four of the five cohorts received 0.6mg, 0.8mg, 1.0mg, or 1.2mg, weekly, without titration, for 12 weeks. Patients in the fifth cohort were also given weekly doses but instead received escalated doses of 0.4mg for four weeks, then 0.8mg for a further four weeks, then 1.2mg for another four weeks.

At the same time, the trial found the treatment to be generally well tolerated with mild gastrointestinal adverse events described by the company as moderate and short-lived. Following this, at week 13, cohorts who were then stepped up to a four-fold higher dose similarly saw the regimen well-tolerated in all cohorts.

John Buse, director of the University of North Carolina Diabetes Center, said: “Taken together, this data suggests that MET-097i has the potential to be a foundational therapy for people with obesity and overweight, by virtue of its effectiveness, compelling tolerability profile and flexible options for dosing, including titration-free weekly dosing and monthly dosing.”

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If successful in later stage trials, the company will be entering into a market space currently dominated by Novo Nordisk’s Weygovy and Eli Lilly’s Zepbound with the new entrant having the significant advantage of the potential for monthly a dosing regimen where as Zepbound and Weygovy. The company is preparing for Phase III trials set to begin this year.

Elsewhere in the same market, Novo Nordisk has taken a hit after its newest experimental weight loss drug, CagriSema, fell short of expectations which dropped the company’s stock price.