MET097 for Obesity

(VESPER-3 Trial)

Recruiting at 4 trial locations

Overseen By Metsera Recruiting

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Metsera

Must be taking: Blood pressure, Lipid-lowering

Disqualifiers: Diabetes, Pancreatitis, MDD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to test the weight loss effects, safety, and tolerability of multiple monthly doses of MET097 after 12 weekly doses, compared to placebo. Participants are eligible if they have overweight or obesity and do not have type 2 diabetes.

Eligibility Criteria

This trial is for adults with obesity or overweight who do not have type 2 diabetes. It's designed to see if a once-monthly dose of MET097 helps with weight loss compared to a placebo.

Inclusion Criteria

Body mass index (BMI) at Screening of BMI ≥30 kg/m2 and ≤50.0 kg/m2

My BMI is between 27 and 30, and I have a weight-related health issue.

Exclusion Criteria

Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0 mIU/L at the Screening visit

Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2

My blood pressure is not well controlled.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once weekly doses of MET097 or placebo for 12 weeks, followed by once monthly doses for 13 months

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 half-lives of the drug

Treatment Details

Interventions

• MET097

Trial Overview The study tests the effectiveness and safety of MET097, given monthly after an initial 12 weekly doses, in promoting weight loss versus a non-active placebo over the same period.

Participant Groups

Group I: MET097 Experimental Treatment 1 Intervention

Participants will be randomized to one of four dosing regimens receiving twelve weekly doses of MET097 (with or without titration) followed by multiple monthly doses.

Group II: Placebo Placebo Group 1 Intervention

Participants who are randomized to the placebo arm will receive twelve weekly doses of placebo followed by multiple monthly doses.

Who Is Running the Clinical Trial?

Metsera

Lead Sponsor

Trials

3

Recruited

610+