Long-Acting GLP-1 Shows Positive Results in Phase 2 Study

January 8, 2025

News

Article

MET-097i from Metsera demonstrated substantial reductions in mean body weight in patients with obesity or overweight who did not have type 2 diabetes.

Positive results have been announced from a phase 2a trial evaluating the efficacy and safety of MET-097i for the treatment of obesity and overweight in patients who do not have type 2 diabetes (T2D), Metsera announced in a release.¹The biopharmaceutical company said it plans to initiate phase 3 trials pending data from other studies on the therapy.

Long-Acting GLP-1 Shows Positive Results in Phase 2 Study / 9dreamstudio - stock.adobe.com

Results from the trial showed that treatment with MET-097i resulted in substantial reductions in mean body weight with no weight loss plateau. The therapy was also seen to be well tolerated with most adverse events being mild or moderate in severity.

“Taken together, these data suggest 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,” John Buse, MD, director of the UNC Diabetes Center at University of North Carolina School of Medicine, said in a release.¹

MET-097i is a fully-biased, once-monthly, ultra-long acting, subcutaneously injectable glucagon-like peptide-1 (GLP-1) receptor agonist. The therapy incorporates the company’s novel peptide lipidation platform technology, which allows peptides to bind simultaneously to albumin and a drug target. This results in a half-life similar to albumin and exceeds that of other GLP-1s.

The study was a randomized, double blind, placebo-controlled, Phase 2a trial evaluating the efficacy and safety of MET-097i in patients with obesity or overweight who did not have T2D. The study cohort included 120 patients separated into 5 cohorts, in which patients received either 0.6 mg, 0.8 mg, 1.0 mg, or 1.2 mg weekly for 12 weeks without titration. In the fifth cohort, patients received escalated doses of 0.4 mg for 4 weeks, 0.8 mg for 4 weeks, and 1.2 mg for 4 weeks.

Additionally, all patients were given either a 2- or 4-fold dose increase at week 13 in order to assess the tolerability of switching to a pharmacologically matched, monthly dose.

The study found that the mean body weight reduction in patients who received MET-097i was 11.3%, with individual responses as high as ~20%. No patients reached a weight loss plateau, suggesting that more weight loss could occur with longer-term dosing. In the titration-free cohorts, pharmacological exposure accumulated approximately 4-fold over 12 weeks.

Treatment with MET-097i was well tolerated, with gastrointestinal adverse events being mild or moderate in severity. In the cohort who received titrated doses, only 1 case of mild, transient nausea and 2 cases of mild, transient vomiting were observed.

“These data strengthen our view of MET-097i as the potential first ultra-long acting GLP-1 [receptor agonist],” Steve Marso, MD, chief medical officer of Metsera, said in a release.¹ “The powerful reductions in weight affirm our earlier studies. We are also excited by the emerging tolerability and dosing profile of MET-097i, which may offer versatility and meaningful advantages for patients.”

Are you ready to elevate your pharmacy practice? Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.