MET097 for Obesity

(VESPER-1 Trial)

Not currently recruiting at 2 trial locations

Overseen By Metsera Recruiting

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Metsera

Disqualifiers: Diabetes, Pancreatitis, Thyroid carcinoma, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a drug called MET097 for individuals who are overweight or have obesity. Participants will receive either MET097 or a placebo (a substance with no active drug) once a week for 28 weeks. Those with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with conditions like high blood pressure or cholesterol, may qualify. The trial aims to determine if MET097 aids in weight loss compared to the placebo. After the main study, participants may join an additional phase for further exploration. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants can be on blood pressure or lipid-lowering medications if they have related co-morbidities.

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. However, it mentions that participants can be on blood pressure or lipid-lowering medications, so it seems you may continue those.

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

Research has shown that MET097 has been promising in earlier studies. This medication works over a long period to aid weight loss by affecting appetite and metabolism. Studies found that MET097 led to significant weight loss, with some participants losing up to 14.1% of their weight in 28 weeks.

Regarding safety, past research suggests that MET097 is generally well-tolerated, with most participants not experiencing serious side effects. Administered as a weekly injection, the treatment has minimal side effects, making it a potentially favorable option in its category.

However, as with any treatment, individual reactions may vary. It is important to discuss any concerns with healthcare providers and understand the potential risks and benefits before joining a trial. ^{1 2 3 4 5}

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

Unlike the standard obesity treatments, which often include oral medications or lifestyle changes, MET097 is unique because it is administered subcutaneously once a week. This delivery method might improve patient adherence and convenience. Additionally, researchers are intrigued by its potential to offer effective weight management without the need for titration, setting it apart from many existing treatments that require gradual dosage adjustments. The extension phase also explores less frequent dosing, which could further enhance its practicality for long-term use.

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

Research has shown that MET097, which participants in this trial may receive, can help people with obesity lose a significant amount of weight. In one study, participants taking MET097 lost up to 14.1% more weight than those taking a placebo over 28 weeks. Another study found that people taking a 1.2 mg dose of MET097 lost 11.3% of their weight in just 12 weeks. MET097 targets a specific receptor in the body to aid in weight reduction. Overall, these findings suggest that MET097 could be a promising option for managing obesity. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with obesity or overweight who are interested in testing a new treatment. Participants will be given either MET097 at varying doses or a placebo once weekly for 16 weeks.

Inclusion Criteria

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

Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening

My BMI is between 27 and 30, and I have hypertension, dyslipidemia, or both.

Exclusion Criteria

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

I have diabetes or my blood sugar levels are high.

I have a history of MTC or MEN-2 in my family or myself.

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 once weekly for 28 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

11 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MET-097

Trial Overview The study aims to determine the safety and effectiveness of four different dosing regimens of MET097, administered once a week, compared to a placebo in treating obesity over the course of 16 weeks.

How Is the Trial Designed?

Group I: MET097 Active Experimental Treatment 1 Intervention

MET097 will be administered at four different dose levels subcutaneously once-weekly without titration. The extension phase includes dosing regimens that are less frequent than weekly.

Group II: Placebo Placebo Group 1 Intervention

Sterile 0.9% (w/v) saline will be used as placebo treatment during the study.

Who Is Running the Clinical Trial?

Metsera

Lead Sponsor

Trials

3

Recruited

610+

Published Research Related to This Trial

Current obesity treatments primarily work by affecting the adrenergic and serotonergic pathways to regulate appetite and satiety, with clinical trials showing a typical weight loss of 10-15%.

While most adverse effects from these treatments are mild and self-limiting, there is a potential for serious adverse events, highlighting the need for more long-term safety and efficacy studies as well as exploration of combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the pharmacotherapy of obesity. Cerulli, J., Lomaestro, BM., Malone, M.[2017]

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

There are currently three main drugs approved for obesity treatment by both the European Medicines Agency and the FDA: orlistat, a combination of bupropion and delayed-release naltrexone, and liraglutide, with additional options available only from the FDA.

The choice of obesity medication should be personalized based on factors like expected weight loss, safety, administration route, and cost, highlighting the need for individualized treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Past, present and future of pharmacotherapy for obesity. Benaiges, D., Pedro-Botet, J., Flores-Le Roux, JA., et al.[2018]

Liraglutide and semaglutide, GLP-1 receptor mimetics, have been approved for weight management in obese individuals, showing promising results in Phase III clinical trials.

Tirzepatide, a GLP-1R and GIPR co-agonist, has received Fast Track designation for obesity management and may offer fewer side effects, suggesting it could be a more sustainable option for long-term weight management compared to existing GLP-1R mimetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLP-1/GIP analogs: potential impact in the landscape of obesity pharmacotherapy. Lafferty, RA., Flatt, PR., Irwin, N.[2023]

Two new medications, Lorcaserin and Phentermine/Topiramate extended release, have been approved by the FDA to aid in weight loss for obese and overweight patients, showing significant efficacy in reducing weight and cardiovascular risk factors.

Lorcaserin works as a selective serotonin 5-HT2C agonist, while Phentermine/Topiramate combines two previously effective agents, both demonstrating safety and effectiveness in clinical studies compared to older obesity treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New pharmacological treatments for the management of obesity. Hurt, RT., Edakkanambeth Varayil, J., Ebbert, JO.[2022]

The conference highlighted various innovative approaches to developing safe and effective obesity drugs, focusing on different neuroendocrine and peripheral tissue targets, which is crucial given the global obesity epidemic.

Key agents discussed included rimonabant, which has completed extensive phase III trials, and early-stage drugs like selective 5-HT(2C) agonists and synthetic analogs of gut hormones, indicating a diverse pipeline of potential treatments for obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity Drug Development Summit. 21-22 July, 2005, Arlington, VA, USA. Maggio, CA.[2007]

Lorcaserin, an FDA-approved medication for obesity, effectively promotes weight loss by targeting the serotonin (5HT2c) system to induce feelings of fullness, as demonstrated in three large Phase III trials involving overweight and obese participants.

The recently approved once-daily formulation of lorcaserin (XR) is bioequivalent to the twice-daily version (IR), which may enhance patient adherence and improve overall treatment effectiveness, while being generally well tolerated with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenging obesity, diabetes, and addiction: the potential of lorcaserin extended release. Hurt, RT., Mundi, MS., Ebbert, JO.[2023]

Currently, four drugs are approved for chronic weight management in obese adults: orlistat, lorcaserin, phentermine/topiramate extended release, and naltrexone/bupropion extended release, each with evidence supporting their safety and efficacy.

The review highlights ongoing development of new monotherapies and combination products that could enhance treatment options for obesity, addressing a significant public health crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment of obesity: current status and future prospects. Kakkar, AK., Dahiya, N.[2022]

In a 12-week phase II study involving 147 participants, beloranib treatment led to significant weight loss, with reductions of up to 10.9 kg at the highest dose, compared to only 0.4 kg with placebo.

Beloranib was associated with improvements in various health markers, such as waist circumference and blood pressure, but the highest dose (2.4 mg) resulted in more mild to moderate gastrointestinal issues and sleep disturbances, indicating a need for careful dose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of beloranib for weight loss in obese adults: a randomized controlled trial. Kim, DD., Krishnarajah, J., Lillioja, S., et al.[2019]

Newly approved antiobesity drugs like lorcaserin and the phentermine/topiramate combination have shown significant weight loss and improvements in cardiometabolic health risks.

While adverse events from these medications are rare and often decrease over time, specific safety concerns must be addressed, highlighting the need for well-trained healthcare providers in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of new antiobesity drugs. Hainer, V.[2018]

A review of obesity drug therapies in development highlights various mechanisms, including central nervous system targets to reduce food intake and gastrointestinal lipase inhibitors to decrease fat absorption, indicating a multifaceted approach to treating obesity.

New drug combinations, such as topiramate with phentermine and bupropion with naltrexone, show promise for greater efficacy and fewer side effects, suggesting advancements in obesity treatment despite previous drug withdrawals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the pathophysiology and pharmacological treatment of obesity. Chugh, PK., Sharma, S.[2012]

Obesity is becoming a leading cause of premature death in developed countries, significantly impacting healthcare costs and quality of life, which highlights the urgent need for effective treatments.

Current pharmacotherapy options for obesity are limited, but the review discusses both existing anti-obesity medications and potential new agents that are in phase II and III clinical trials, emphasizing the importance of combining these treatments with lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New agents in development for the management of obesity. Vincent, RP., le Roux, CW.[2022]

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. 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.

3. 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 ...

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

Metsera's GLP-1 Receptor Agonist MET-097i | ADA 2025 MET-097 demonstrated a clear dose-dependent reduction in body weight, with the 1.2 mg dose group achieving a 7.5% mean weight loss from baseline ...

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