MET233 for Obesity

Overseen By Metsera Recruiting

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Metsera

Disqualifiers: Pregnancy, Hypertension, Diabetes, ECG abnormalities, others

Compensation: Varies

Number of Visits: 19

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment called MET233 for individuals dealing with overweight or obesity. Participants will receive subcutaneous (under-the-skin) injections of either MET233 or a placebo to observe the body's reaction. The trial consists of three parts: starting with single doses, progressing to multiple doses over several weeks, and concluding with a series of weekly doses followed by a higher single dose. Ideal participants are adults with a BMI between 27.0 and 38.0 who are otherwise healthy. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 MET233 is likely to be safe for humans?

Research has shown that MET233 was well-tolerated in past studies. In one study, participants who took MET233 lost an average of 8.4% of their body weight compared to those who took a placebo, suggesting its effectiveness. This study also found that MET233 remains active in the body for an extended period, allowing for once-a-month dosing. Importantly, the study demonstrated that MET233 is safe, as participants did not experience any major side effects.

Since the current trial is in its early stages, safety remains a primary focus. At this phase, researchers typically test treatments on a small group to check for any harmful effects. The testing of MET233 in humans indicates that earlier lab tests were promising. However, it is crucial for participants to report any side effects they experience during the trial. ^{1 2 3 4 5}

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

Researchers are excited about MET233 for obesity because it offers a novel approach compared to standard treatments like lifestyle changes, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. Unlike these treatments, MET233 is being tested at multiple dosage levels and schedules, which could provide tailored options for patients. Additionally, it aims to offer a more precise mechanism of action that could lead to enhanced weight loss outcomes and potentially fewer side effects. If successful, MET233 could provide a new and effective way to manage obesity, expanding the options available to patients and healthcare providers.

What evidence suggests that MET233 might be an effective treatment for obesity?

Research has shown that MET233 may aid in weight loss. In a previous study, participants taking MET233 lost an average of 8.4% more weight than those on a placebo by Day 36. This trial will administer MET233 in different parts, with varying dose levels and frequencies. The treatment remains active in the body for about 19 days, allowing for monthly doses. These findings suggest that MET233 could be a promising option for managing obesity. ^{2 3 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 must not have any other significant health issues that could interfere with the study.

Inclusion Criteria

I am between 18 and 70 years old, overweight or obese, but otherwise healthy.

Exclusion Criteria

Seated blood pressure higher than 160/95 mmHg at the Screening visit

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

Presence of clinically significant ECG abnormalities

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 a single dose of MET233 or placebo at up to 5 dose levels

1 week

1 visit (in-person)

Part B: Multiple Ascending Dose (MAD)

Participants receive five weekly doses of MET233 or placebo at up to 4 dose levels

5 weeks

5 visits (in-person)

Part C: Extended Dosing

Participants receive twelve weekly doses of MET233 or placebo, followed by a 13th potential monthly dose

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

• MET233

Trial Overview The study tests MET233, a new potential treatment for obesity. It involves three parts: single doses, multiple weekly doses, and a longer-term dosing with an additional higher dose to evaluate its safety and effects on the body.

How Is the Trial Designed?

Group I: (Part C) MET233 Experimental Treatment 1 Intervention

Participants will receive twelve weekly doses of MET233 at up to 4 dose levels, followed by a 13th potential monthly dose

Group II: (Part B) MET233 Experimental Treatment 1 Intervention

Participants will receive five weekly doses of MET233 at up to 4 dose levels

Group III: (Part A) MET233 Experimental Treatment 1 Intervention

Participants will receive a single dose of MET233 at up to 5 dose levels

Group IV: (Part A) Placebo Placebo Group 1 Intervention

Participants will receive a single dose of placebo

Group V: (Part B) Placebo Placebo Group 1 Intervention

Participants will receive five weekly doses of placebo

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

Participants will receive twelve weekly doses of placebo, followed by a 13th potential monthly dose

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-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 ...

2. 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.

3. 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 ...

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. 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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07022977

A Study of MET233 in Individuals With Obesity or Overweight The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 ...

7. synapse.patsnap.com synapse.patsnap.com/drug/74c5e85d42704bada78c61c17191e04e

MET-233 - Drug Targets, Indications, Patents Metsera shares early data on anti-obesity amylin candidate. Metsera, which is attempting to make long-acting obesity and metabolic disease medicines, has ...