MET097 for Diabesity

(VESPER-2 Trial)

Recruiting at 5 trial locations

Overseen By Metsera Recruiting

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Metsera

Must be taking: Metformin, SGLT-2

Disqualifiers: Pregnancy, Hypertension, Stroke, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, MET097, to evaluate its effectiveness for individuals with both obesity or overweight and type 2 diabetes. Participants will receive weekly injections of either MET097 or a placebo for 28 weeks. Those receiving MET097 will follow one of four different dosing plans. Suitable candidates have had type 2 diabetes for at least three months with stable treatment and a steady body weight. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable therapy for at least 30 days before the trial, which suggests you may continue your current treatment if it's stable.

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

Research shows that MET097, a new long-lasting treatment, is promising in terms of safety. Earlier studies linked this treatment to significant weight loss while maintaining safety. Reports indicate it is well-tolerated, meaning most people experience few side effects. Although specific details on side effects are not provided here, current evidence from ongoing studies suggests that MET097 is generally well-tolerated. As always, individual reactions can vary, so discussing any concerns with the trial team is important. ^{1 2 3 4 5}

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

Unlike the standard treatments for diabesity, which often involve a combination of lifestyle changes and medications like metformin and GLP-1 receptor agonists, MET097 offers a novel approach. Researchers are excited about MET097 because it potentially targets the metabolic pathways associated with both diabetes and obesity in a unique way. The study includes two experimental arms: one where MET097 is given without titration and another with titration. This flexibility could mean more personalized treatment options, leading to better outcomes for patients struggling with diabesity.

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

Research has shown that MET097, a new long-lasting medication, may help treat obesity and type 2 diabetes. In earlier studies, participants taking MET097 lost an average of 14.1% more weight than those on a placebo after 28 weeks. This weight loss continued steadily, indicating the treatment's sustained effectiveness. Even after stopping MET097, participants maintained weight loss, averaging 8.1% at Day 57 and 7.5% at Day 85. These findings suggest MET097 could be a strong option for managing weight in adults with obesity or overweight issues and type 2 diabetes. Participants in this trial will receive either MET097 with or without titration, or a placebo, to further evaluate its effectiveness. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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

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

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

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

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MET097 or placebo via subcutaneous injection once weekly

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MET097

Trial Overview The 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.

How Is the Trial Designed?

Group I: MET097 Active without titration Experimental Treatment 1 Intervention

Group II: MET097 Active with titration Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Metsera

Lead Sponsor

Trials

3

Recruited

610+

Published Research Related to This Trial

The U.S. FDA has approved six classes of oral medications for type 2 diabetes, with metformin and lifestyle changes recommended as the first-line treatments according to a consensus by the American Diabetes Association and the European Association for the Study of Diabetes.

New therapies in development, including incretin therapies and agents targeting metabolic syndrome, show promise for improving treatment options for type 2 diabetes, especially for patients struggling with weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes: new and future developments in treatment. Liao, EP.[2022]

The CAIPaDi program, which includes 9 interventions over 7 hours, effectively helped 80.6% of participants achieve an HbA1c level below 7% after the initial 4 visits, indicating strong short-term efficacy in managing type 2 diabetes.

Sustained improvements were observed over 24 months, with 61.0% of patients maintaining HbA1c <7%, and significant enhancements in empowerment and quality of life, while anxiety and depression levels remained low, suggesting the program's holistic approach is beneficial for long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a type 2 diabetes comprehensive care program. The CAIPaDi model. Hernández-Jiménez, S., García-Ulloa, AC., Bello-Chavolla, OY., et al.[2019]

A review of 243 elderly patients with type 2 diabetes showed that metformin is safe for long-term use, with no significant changes in liver and renal function or blood lactic acid levels after treatment.

While metformin effectively reduced blood glucose levels in some patients, it was most effective when combined with other medications, indicating that combination therapy may be necessary for better management of diabetes in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety of metformin in the treatment of elderly type 2 diabetes mellitus]. Tian, H., Li, CL., Yang, G., et al.[2017]

In a study of 14,512 patients with type 2 diabetes, those treated with sulphonylureas (SUs) and thiazolidinediones (TZDs) experienced significantly more adverse events (AEs) compared to those treated with metformin (MET), with rates of 15.9% and 19.8% respectively, versus 8.6% for MET.

While AEs did not significantly affect overall glycaemic control (A1C levels), they did influence treatment patterns, leading to more patients on MET and SU switching therapies or adding additional treatments after experiencing AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes. Asche, CV., McAdam-Marx, C., Shane-McWhorter, L., et al.[2022]

The review highlights that while there are many innovative drugs being developed for type 2 diabetes, several have faced serious safety issues, leading to their withdrawal or halting of development.

It discusses the current state of treatments, including glitazones, incretin mimetics, SGLT-2 inhibitors, and new experimental drugs, emphasizing the need for better methods to predict and differentiate drug-related adverse events from natural disease occurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benefits and risks of current pharmacotherapy in the treatment of type 2 diabetes]. Schindler, C., Barthel, A., Fischer, S., et al.[2021]

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 ... Placebo-subtracted mean weight loss up to 14.1% after 28 weeks with no plateau. Potential for best-in-class tolerability with minimal ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/788-P/159756/788-P-A-Twelve-Week-Trial-of-MET097-A-Potent-and

788-P: A Twelve-Week Trial of MET097—A Potent and Ultra ... Methods: A Ph2, multicenter, randomized, double-blind, placebo (PBO)-controlled trial enrolled adults with overweight/obesity (BMI 27-38 kg/m²).

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. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/586316

A Study to Evaluate the Efficacy and Safety of Once-Weekly ... 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 ...

6. 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 ...