MET097 for Diabesity
(VESPER-2 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Metsera

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.

Research Team

Eligibility Criteria

Adults with obesity or overweight and type 2 diabetes mellitus (T2DM) are eligible for this trial. Participants must be able to receive weekly subcutaneous injections for 28 weeks. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I have had type 2 diabetes for at least 3 months.

BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening

My HbA1c is between 7.0% and 10.5%, and I've been on a stable diabetes treatment for over 30 days.

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Exclusion Criteria

I have had a stroke in the past.

Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2

Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)

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Treatment Details

Interventions

MET097 (GLP-1 Receptor Agonist)

Trial OverviewThe study is testing the effectiveness of MET097, an ultra-long-acting GLP-1 receptor agonist, compared to a placebo in managing diabesity. Participants will either get MET097 or a placebo in one of four different dose regimens by chance.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: MET097 Active without titrationExperimental Treatment1 Intervention

Group II: MET097 Active with titrationExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention