3500 Participants Needed

MET097 for Obesity

(VESPER-4 Trial)

Recruiting at 4 trial locations
MR
Overseen ByMetsera Recruiting
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Metsera
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new once-weekly injection called MET097 to determine if it safely aids weight loss. It targets adults who are obese or overweight and have weight-related health issues such as high blood pressure, high cholesterol, sleep apnea, or heart problems, but not diabetes. Participants will receive one of three different doses of MET097 or a placebo (a shot with no active medication). The trial lasts for 84 weeks, with the main results assessed after 64 weeks. Those who have gained or lost more than 11 pounds recently or have diabetes are not eligible. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new weight-loss treatment.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MET097, a weekly injection for obesity, is generally safe. Studies indicate that most people tolerate MET097 well. Importantly, no serious side effects related to the treatment have been reported, which is a positive sign for its safety.

Previous studies with MET097 demonstrated that it can help people lose weight without causing serious side effects. This suggests that the treatment is not only effective but also safe for those considering joining a trial. While every medication can have side effects, the results so far are promising for MET097.12345

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

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or surgical options, MET097 is a novel approach administered via subcutaneous injection. Researchers are particularly excited about MET097 because it may offer a new mechanism of action, potentially targeting pathways that existing medications do not. This could lead to more effective weight management with possibly fewer side effects. The excitement also stems from its potential to provide consistent, long-lasting results, which is a significant challenge in current obesity treatments.

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

Research has shown that MET097, a medication that controls appetite and blood sugar, leads to significant weight loss. One study found that participants lost an average of 7.5% of their body weight, and this weight loss persisted even after discontinuing the medication. Another study reported an 8.1% reduction in body weight after 36 days. These findings suggest that MET097 can effectively help individuals with obesity or overweight conditions lose weight and maintain it over time. Participants in this trial will receive one of three different doses of MET097 or a placebo to further evaluate its effectiveness.12467

Are You a Good Fit for This Trial?

This trial is for adults with obesity or overweight who also have hypertension, dyslipidemia, sleep apnea, or cardiovascular disease. Participants should not have diabetes, significant weight changes in the past 3 months, a history of certain thyroid cancers (MTC), genetic conditions like MEN-2, chronic pancreatitis or recent acute pancreatitis.

Inclusion Criteria

My BMI is over 27 and I have a weight-related health issue like high blood pressure or heart disease.

Exclusion Criteria

Have any form of diabetes
I have lost or gained more than 11 pounds in the last 3 months.
I or my family have a history of MTC or MEN-2.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-weekly injectable MET097 or placebo for 64 weeks

64 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MET097

Trial Overview

The study tests MET097's effectiveness and safety when injected once weekly into adults with obesity-related health issues over an 84-week period. The main results are measured at week 64 and secondary outcomes at week 84. A placebo group serves as a comparison to see if MET097 really works.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: MET097 Dose 3Experimental Treatment1 Intervention
Group II: MET097 Dose 2Experimental Treatment1 Intervention
Group III: MET097 Dose 1Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Metsera

Lead Sponsor

Trials
3
Recruited
610+

Citations

Metsera Announces Positive Phase 1 Results for MET-097, ...

MET-097 demonstrated significant and sustained weight loss, achieving a 7.5% reduction in body weight. • The weight loss was maintained for at ...

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 ...

Efficacy and Safety of MET097 Once-Weekly in People ...

This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related ...

Metsera GLP-1 data slice reveals 7.5% weight loss at 36 ...

For patients receiving Metsera's investigational injection at the 1.2-mg dose, weight loss continued after 36 days, with an 8.1% cumulative ...

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.

NCT06712836 | A Phase 2b Study to Examine the Safety ...

This study is designed to test how well MET097, an active drug, works to treat individuals with obesity or overweight when compared to placebo. MET097 or ...

Long-acting GLP-1 lowers weight for adults with obesity

Adults receiving once-weekly 1.2 mg MET-097 lost 12.5% of their body weight at 28 weeks. An interim analysis of VESPER-3 revealed that ...