In short
MET097 is an investigational protein-based medicine given as a once-weekly injection under the skin. It is being studied in three Phase 3 trials that together plan to enrol 5,453 adults with obesity or overweight, including one trial in people who also have type 2 diabetes. The main measure in the two MET097 trials is the percent change in body weight from baseline at Week 64.
Key points
- Phase 3 trials are testing MET097 against placebo in obesity and overweight.
- The largest MET097 trial plans to enrol 3,500 participants.
- MET097 is given as a once-weekly subcutaneous injection at a strength of 5 mg/mL.
- The primary endpoint is percent change in body weight at Week 64.
- A separate Phase 3 trial, VESPER-5, includes people with type 2 diabetes and plans 999 participants.
- MET097 has no marketing authorisation and remains an investigational substance.
What is MET097?
MET097 is an investigational protein-based medicine developed by Metsera Inc. Its full chemical name is L-PHENYLALANYL-2-METHYLALANYL-L-ALFA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALFA-ASPARTYL-L-VALYL-L-SERYL-L-LYSYL-L-GLUTAMINYL-L-LEUCYL-L-ALFA-GLUTAMYL-L-ALFA-GLUTAMYL-L-LYSYL-L-ARGINYL-L-VALYL-L-ARGINYL-L-ALFA-GLUTAMYL-L-PHENYLALANYL-L-ISOLEUCYL-L-ALFA-GLUTAMYL-L-TRYPTOPHYL-L-LEUCYL-L-LYSYL-L-GLUTAMINYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-LYSYL-L-PROLYL-L-PROLYL-L-PROLYLGLYCYL-L-LYSYL-N6-[N-(19-CARBOXY-1-OXONONADECYL)-L-GAMMA-GLUTAMYL]-L-LYSINE. In the trial records it appears as MET097 Injection, 5 mg/mL. The substance has no marketing authorisation in the product records, meaning it is still under investigation and not approved as a medicine. The therapeutic area of the trials is nutritional and metabolic diseases.
How does MET097 work?
The clinical trial records do not describe the molecular target or mechanism of action of MET097. No supplementary sources were provided to explain how the substance acts in the body. The registry data identify MET097 as a protein-based substance of the class "Protein - Other", which means it is not a small chemical molecule but a larger biological molecule. The trials measure its effect on body weight in people with obesity or overweight.
Which conditions is it studied for?
- Obesity — the VESPER-4 trial enrols people with overweight or obesity and plans 3,500 participants.
- Overweight or obesity with type 2 diabetes — the VESPER-5 trial studies MET097 in people who have overweight or obesity and also type 2 diabetes, with a planned enrolment of 999 participants.
- Overweight or obesity — a third Phase 3 trial listed in the data investigates a different investigational substance, PF-08653944, in 954 adults with overweight or obesity.
How is MET097 given?
MET097 is given as a solution for injection by subcutaneous injection, which means it is injected under the skin. The product name in the trial records is MET097 Injection, 5 mg/mL. The trials describe a once-weekly dosing schedule.
What do the clinical trials show?
Three Phase 3 interventional trials are listed in the data. Two of them test MET097 against a matching placebo, and one tests a different substance, PF-08653944, also against placebo. All three are in the authorised status, meaning they have received regulatory approval to start but have not yet reported results.
The VESPER-4 trial is the largest, with a planned enrolment of 3,500 people with overweight or obesity. Its primary outcome is the percent change from baseline in body weight at Week 64. The VESPER-5 trial has the same primary outcome and a planned enrolment of 999 participants with overweight or obesity and type 2 diabetes. The third trial, studying PF-08653944, measures body weight percent change from baseline at Week 72 in 954 adults.
The brief summaries state that the MET097 trials aim to demonstrate the superiority of once-weekly MET097 compared with placebo in percent change from baseline body weight at Week 64.
What side effects are known?
No supplementary sources were provided with information on side effects of MET097. The clinical trial records do not report adverse event data because the trials have not yet published results. Therefore, no side effect information can be stated for this substance.