Metsera (MTSR) Study Result summary

Study design and objectives

• Phase 1 trial evaluated MET-233/MET-233i, a first-in-class monthly amylin analog, in overweight or obese adults without type 2 diabetes using single and multiple ascending dose cohorts, each enrolling 40 participants, with a total of 80 participants in some reports.

• Randomized, placebo-controlled, double-blind design with five SAD (0.15–2.4 mg) and four MAD (0.15–1.2 mg) cohorts; baseline mean BMI was approximately 32 with balanced demographics.

• Objectives included characterizing pharmacokinetics, measuring weight loss at weeks one and five, and identifying well-tolerated starting doses.

Pharmacokinetics and dosing

• MET-233/MET-233i demonstrated a 19-day observed half-life, supporting once-monthly dosing and dose-linear pharmacokinetics with low variability.

• PK profiles of MET-233/MET-233i and MET-097i are highly similar, enabling seamless combination therapy.

Efficacy results

• Up to 8.4% placebo-subtracted mean weight loss was observed after five weekly doses in the highest MAD cohort, with individual responses up to 10.2%.

• Dose-dependent and rapid onset of weight loss was seen, with efficacy persisting weeks after dosing.

• Class-leading weight loss was achieved at low, scalable dose levels.