MET097 for Obesity

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Metsera

Disqualifiers: Pregnancy, Hypertension, Diabetes, Cushing's, others

Compensation: Varies

Number of Visits: 19

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MET097 for individuals with overweight or obesity. Researchers aim to determine the safety and effectiveness of weekly injections of this treatment. The trial includes different parts to test various doses, with one part exploring the possibility of monthly dosing. It seeks adults who are overweight or obese but otherwise healthy, with a BMI between 27 and 38. As a Phase 1 trial, this research focuses on understanding how MET097 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for 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 MET097 is likely to be safe for humans?

Research has shown that MET097 is generally safe and well-tolerated. In earlier studies, participants did not experience any serious side effects from the treatment. MET097 is being tested as a long-lasting medication for weight loss. Some studies reported significant weight loss without major issues. While these results are encouraging, this trial will help confirm the safety and effectiveness of MET097. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or even bariatric surgery, MET097 is unique due to its method of administration and potential mechanism of action. MET097 is delivered through a once-weekly subcutaneous injection, which could offer more convenience and better adherence compared to daily oral medications. Researchers are particularly excited about MET097 because it may target metabolic pathways differently, potentially providing an innovative approach to weight management. This could lead to more effective and sustained weight loss outcomes compared to current options.

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

Research has shown that MET097, a long-acting medication, can significantly aid in weight loss. One study demonstrated a 14.1% reduction in body weight over 28 weeks, which is impressive. Another study reported up to an 11.3% weight loss after 12 weeks compared to those taking a placebo, a pill with no active ingredients. Even after stopping the treatment, participants maintained a 7.5% weight loss by Day 85. In this trial, participants will receive either MET097 or a placebo as a once-weekly subcutaneous injection for 13 weeks. These findings suggest that MET097 may effectively help individuals with obesity lose weight. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults who are overweight or obese. Participants will receive weekly injections and may be eligible if they meet specific weight criteria, but can't join if they have other significant health issues or are taking certain medications that could interfere with the study.

Inclusion Criteria

Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator

Estimated glomerular filtration rate (eGFR) ≥90 mL/min at the Screening visit

I am overweight with a BMI between 27.0 and 38.0.

Exclusion Criteria

Elevated resting pulse greater than 100 beats per minute at Screening visit

I have been diagnosed with diabetes.

I have been in a weight loss program in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A - Single Ascending Dose (SAD)

Participants receive single ascending doses of MET097 or placebo

1 week

1 visit (in-person)

Part B - Multiple Ascending Dose (MAD)

Participants receive five once-weekly doses of MET097 or placebo

5 weeks

5 visits (in-person)

Part C - Extended Dosing

Participants receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X

13 weeks

13 visits (in-person)

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 tests MET097, a new drug given as a once-weekly subcutaneous injection to see if it's safe and effective for weight loss. It has three parts: single doses (Part A), multiple doses (Part B), and longer-term dosing with potential monthly options (Part C). Some participants will get a placebo instead of the actual drug.

How Is the Trial Designed?

Group I: (Part C) MET097 Experimental Treatment 1 Intervention

Once-weekly subcutaneous injection of MET097 for 13 weeks

Group II: (Part C) Placebo Placebo Group 1 Intervention

Once-weekly subcutaneous injection of Placebo for 13 weeks

Who Is Running the Clinical Trial?

Metsera

Lead Sponsor

Trials

3

Recruited

610+

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 ... “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 ...

2. 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 ...

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. 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

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06712836

NCT06712836 | A Phase 2b Study to Examine the Safety ... A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight (VESPER-1). ClinicalTrials.gov ID NCT06712836.