MET233 + MET097 for Obesity

Overseen By Metsera Recruiting

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Metsera

Must not be taking: Glucose-lowering medications

Disqualifiers: Pregnancy, Hypertension, Type 1 diabetes, others

Compensation: Varies

Number of Visits: 6

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of combining two treatments, MET233 and MET097, for individuals who are obese or overweight, including those with type 2 diabetes. Participants will receive either both medications, one medication with a placebo, or only a placebo to determine the most effective combination. This trial may suit individuals with a BMI between 27 and 38 who have no significant health issues other than controlled diabetes, high blood pressure, or cholesterol problems. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you have Type 2 diabetes and are in Part C, you must be on stable therapy for at least 30 days before joining.

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

Research has shown that the combination of MET233 and MET097 was safe in previous studies. In earlier trials, MET233 led to a weight loss of up to 8.4% compared to a placebo over 36 days, indicating it was generally well-tolerated. MET097, another part of the treatment, resulted in a significant weight loss of 14.1% over 28 weeks in other studies, with only 2.9% of participants experiencing notable side effects.

These results suggest that both MET233 and MET097 were generally well-tolerated in past trials. Since this study is in the early testing phase (Phase 1), it primarily focuses on safety. Participants should know that the treatment is still under careful evaluation for any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MET233 and MET097 for obesity because these treatments represent a novel approach in tackling weight management. Unlike typical obesity treatments that often rely on appetite suppression or calorie absorption reduction, MET233 and MET097 may offer a unique mechanism of action, potentially targeting metabolic pathways more directly. Additionally, both treatments are administered subcutaneously, which could provide a more consistent drug delivery compared to oral medications. This innovative approach might lead to more effective weight loss solutions, potentially improving outcomes for individuals struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that using MET233 together with MET097 can aid in weight loss. In earlier studies, participants taking MET097 lost an average of 14.1% of their body weight over 28 weeks. MET233 also produced positive results, helping participants lose up to 8.4% more weight than those taking a placebo in just 36 days. In this trial, participants will receive either MET233 co-administered with MET097, MET233 with a placebo, or a placebo alone. This combination could benefit individuals who are obese or overweight, even if they have diabetes. These findings suggest that this treatment might effectively promote weight loss. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with a BMI between 27 and 38, who may or may not have type 2 diabetes (T2DM). Those with T2DM must have stable treatment for at least a month. Excluded are individuals with high blood pressure, certain pancreatic conditions, uncontrolled heart rate, severe kidney issues, Type 1 diabetes, significant weight-related health problems, or recent weight loss treatments.

Inclusion Criteria

BMI ≥27 kg/m2 and ≤38.0 kg/m2 at screening

I have been diagnosed with type 2 diabetes for at least 3 months.

I don't have any significant health issues apart from my current condition.

Exclusion Criteria

Seated blood pressure higher than 160/100 mmHg at Screening visit or prior to the first study drug administration

I have never had pancreatitis or pancreatic cancer.

I have type 2 diabetes or my blood sugar levels are high.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Single Ascending Dose (SAD) Treatment

Participants receive a single subcutaneous dose of MET233 co-administered with MET097 or placebo

1 day

1 visit (in-person)

Multiple Ascending Dose (MAD) Treatment

Participants receive weekly subcutaneous doses of MET233 co-administered with MET097 or placebo

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks for Part A, 11 weeks for Parts B and C

What Are the Treatments Tested in This Trial?

Interventions

• MET233 and MET097

Trial Overview The study tests the effectiveness of two drugs combined (MET233 and MET097) versus each drug alone and placebo in treating obesity. It aims to see if these drugs can help people lose weight and manage their diabetes better if they have it.

How Is the Trial Designed?

Group I: SAD: MET233 co-administered with MET097 Experimental Treatment 1 Intervention

Participants in the single ascending dose cohorts will receive subcutaneous MET233 co-administered with MET097 at a single point in time.

Group II: MAD: MET233 co-administered with Placebo Experimental Treatment 1 Intervention

Participants will receive subcutaneous MET233 co-administered with Placebo weekly.

Group III: MAD: MET233 co-administered with MET097 Experimental Treatment 1 Intervention

Participants in the multiple ascending dose cohorts will receive subcutaneous MET233 co-administered with MET097 weekly.

Group IV: MAD: Placebo Placebo Group 1 Intervention

Participants in the multiple ascending dose cohorts will receive subcutaneous Placebo weekly.

Group V: SAD: Placebo Placebo Group 1 Intervention

Participants in the single ascending dose cohorts will receive subcutaneous Placebo at a single point in time.

Who Is Running the Clinical Trial?

Metsera

Lead Sponsor

Trials

3

Recruited

610+

Published Research Related to This Trial

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]

In a study of 3,770 obese individuals from the Korean National Health and Nutrition Examination Survey, waist circumference and waist-to-height ratio were identified as the most accurate indicators of metabolically healthy obesity (MHO), outperforming traditional measures like body mass index.

The prevalence of MHO decreased with age, highlighting the importance of using waist measurements to better identify individuals who are obese but not at risk for metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of obesity indicators for metabolically healthy obesity: an observational study using the Korean National Health and Nutrition Examination Survey (2009-2010). Choi, MK., Han, YA., Roh, YK.[2022]

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]

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]

Mild to moderate obesity affects public health more significantly than severe obesity, indicating a need for effective management strategies targeting this larger population.

An individualized approach to obesity treatment, along with advancements in pharmacologic therapies, may offer better outcomes compared to traditional lifestyle and behavioral modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical therapy for obesity. Dayyeh, BK., Kaplan, LM.[2011]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06924320

NCT06924320 | A Study of MET233 in Combination With ... This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

2. 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 ...

3. withpower.com withpower.com/trial/phase-1-obesity-2-2025-fb186

MET233 + MET097 for Obesity This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/MTSR/pressreleases/35736202/metseras-new-phase-1-study-a-potential-game-changer-in-obesity-treatment/

Metsera's New Phase 1 Study: A Potential Game-Changer ... ' The study aims to evaluate the safety and effectiveness of MET233 combined with MET097 in treating obesity and related conditions, including ...

5. investors.metsera.com investors.metsera.com/news-releases/news-release-details/metsera-announces-positive-phase-1-data-first-class-once-monthly

Metsera Announces Positive Phase 1 Data of First-in-Class ... MET-233i demonstrated up to 8.4% mean placebo-subtracted weight loss at Day 36, a 19-day observed half-life supporting once-monthly dosing, and a favorable ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/601195

A Study of MET233 in Combination With MET097 ... This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or ...