MET097 for Obesity

(VESPER-3 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MET097, a potential weight loss drug, to assess its effectiveness and safety for individuals with overweight or obesity. Participants will receive either MET097 or a placebo (a substance with no active medication) over a series of doses. The researchers aim to determine if MET097 can be a safe and effective option for weight management. Suitable candidates for this trial should have a BMI of 27 or higher, possibly with conditions like high blood pressure or cholesterol, and should not have type 2 diabetes. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. However, if you are on blood pressure or lipid-lowering medications, you may continue them as long as they have been stable for a certain period before the screening.

Is there any evidence suggesting that MET097 is likely to be safe for humans?

Research shows that MET097 is generally safe for patients. An earlier study reported no serious side effects related to the treatment, indicating a positive safety profile. Participants lost a significant amount of weight, and the effects persisted even after stopping the treatment for eight weeks.

Moreover, the treatment appears well-tolerated, with only minor side effects reported. This supports MET097's potential as a treatment for obesity. While these results are encouraging, ongoing trials are essential to fully understand the safety and effectiveness of MET097. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about MET097 for obesity because it offers a novel approach compared to current treatments like lifestyle changes, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. Unlike these treatments, MET097 is being tested in multiple dosing regimens, which might offer more flexibility and personalization for patients. Additionally, MET097 could potentially provide sustained weight loss with fewer side effects, thanks to its unique formulation and dosing schedule. This innovative approach could significantly improve the quality of life for individuals struggling with obesity.

What evidence suggests that MET097 might be an effective treatment for obesity?

Research has shown that MET097, a medication targeting specific receptors in the body, can lead to significant weight loss. In earlier studies, participants using MET097 lost up to 14.1% of their body weight over 28 weeks. This weight loss persisted even after stopping the treatment, with an average loss of 7.5% by Day 85. Another study found that participants lost up to 11.3% more weight than those taking a placebo after 12 weeks. In this trial, participants will receive either MET097 or a placebo at random. These results suggest that MET097 could effectively help individuals with obesity or overweight reduce their weight. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. investors.metsera.com investors.metsera.com/news-releases/news-release-details/metsera-reports-positive-phase-2b-results-first-and-best-class

and Best-in-Class Ultra-long Acting GLP-1 RA Candidate MET ... “As a fully biased mono-agonist, MET-097i achieved dual-agonist-like weight loss of 14.1% at 28 weeks in VESPER-1, with only 2.9% study ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/753-P/158835

753-P: Safety, Tolerability, PK, and Efficacy of MET097—A ... Conclusion: MET097, an ultra-long acting GLP-1RA, results in significant weight loss sustained 8 wks post-treatment. Ongoing Ph2 studies will ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06973720

NCT06973720 | A Phase 2b Study to Evaluate the Efficacy ... 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.

4. delveinsight.com delveinsight.com/blog/metseras-glp-1-receptor-agonist-met-097i

Metsera's GLP-1 Receptor Agonist MET-097i | ADA 2025 Impressively, this effect was sustained even after the end of the dosing period, with a mean weight loss of 8.1% at Day 57 and 7.5% at Day 85.

5. investors.metsera.com investors.metsera.com/news-releases/news-release-details/metsera-announces-positive-topline-phase-2a-clinical-data-its

Metsera Announces Positive Topline Phase 2a Clinical Data ... Positive 12-week results from a Phase 2a trial demonstrated substantial placebo-adjusted weight loss of up to 11.3% in the 1.2mg cohort at day 85 and was ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06857617

NCT06857617 | This Study Will Investigate the Safety, ... The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06712836

NCT06712836 | A Phase 2b Study to Examine the Safety ... A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight (VESPER-1). ClinicalTrials.gov ID NCT06712836.