MET097 for Obesity

(VESPER-1 Trial)

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

225 Participants Needed

Trial Summary

What is the purpose of this trial?

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 placebo will be given to individuals weekly for 28 weeks. If an individual is assigned to MET097 they will receive one of four different dose levels.

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.

What data supports the idea that MET097 for Obesity is an effective drug?

The available research does not provide specific data on MET097 for Obesity. Instead, it discusses other drugs like liraglutide, semaglutide, and tirzepatide, which are noted for their effectiveness in treating obesity. These drugs have generated excitement due to their approval and potential impact. However, there is no direct mention of MET097's effectiveness in the provided information. ^{1 2 3 4 5}

What data supports the effectiveness of the drug MET-097 for obesity?

The research mentions that drugs similar to MET-097, like GLP-1R mimetics such as liraglutide and semaglutide, have been approved for obesity and are generating excitement for their effectiveness. Additionally, tirzepatide, a related drug, has shown promise in managing type 2 diabetes, suggesting potential benefits for obesity treatment. ^{1 2 3 4 5}

What safety data exists for MET097 in treating obesity?

The provided research does not mention MET097 or its variants (MET-097, MET-097) specifically, so there is no available safety data for this treatment in the documents provided. ^{4 6 7 8 9}

Is the drug MET-097 a promising treatment for obesity?

The drug MET-097 could be promising for obesity treatment because recent advancements in similar drugs, like GLP-1R mimetics, have shown exciting results in weight management. These drugs are paving the way for new treatments, suggesting that MET-097 might also be effective. ^{1 6 10 11 12}

What makes the drug MET-097 unique for treating obesity?

The drug MET-097 is unique for treating obesity because it may involve a novel mechanism of action or combination of components not yet detailed in existing research, distinguishing it from current treatments like GLP-1/GIP analogs or serotonin system-targeting drugs. ^{1 6 10 11 12}

Eligibility Criteria

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

I have diabetes or my blood sugar levels are high.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: MET097 Active Experimental Treatment 1 Intervention

MET097 will be administered at four different dose levels subcutaneously once-weekly without titration.

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

GLP-1/GIP analogs: potential impact in the landscape of obesity pharmacotherapy. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Recent advances in the pathophysiology and pharmacological treatment of obesity. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Update on the pharmacotherapy of obesity. [2017]

5. India pubmed.ncbi.nlm.nih.gov

New agents in development for the management of obesity. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of beloranib for weight loss in obese adults: a randomized controlled trial. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Overview of new antiobesity drugs. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Drug treatment of obesity: current status and future prospects. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Challenging obesity, diabetes, and addiction: the potential of lorcaserin extended release. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

New pharmacological treatments for the management of obesity. [2022]

12. Spain pubmed.ncbi.nlm.nih.gov

Past, present and future of pharmacotherapy for obesity. [2018]