MET097 for Obesity

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Metsera

Trial Summary

What is the purpose of this trial?

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 in otherwise healthy adults with overweight or obesity. The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.

Eligibility Criteria

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

I am between 18 and 70 years old.

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

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.

Treatment Details

Interventions

• MET097 (Other)

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.

Participant Groups

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+