A Study of MET233 in Individuals With Obesity or Overweight (NCT07022977) | Clinical Trial Compass
CompletedPhase 1
A Study of MET233 in Individuals With Obesity or Overweight
United States144 participantsStarted 2024-11-06
Plain-language summary
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 in otherwise healthy adults with overweight or obesity.
This study will be conducted in four parts:
* Part A will evaluate single ascending doses of MET233 or placebo.
* Part B will evaluate multiple ascending doses, with participants receiving five once-weekly doses of MET233 or placebo.
* Part C will evaluate once-weekly dosing of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose.
* Part D will evaluate a longer dosing schedule, in which participants will receive twelve once-weekly doses, followed by three monthly doses of MET233 or placebo. Participants in this part will be followed for 14 weeks after the final dose.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult (≥18 to ≤70 years) male and female participants with obesity or overweight (BMI 27.0 kg/m2 to 38.0 kg/m2, inclusive) but otherwise healthy.
Exclusion Criteria:
* Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration
* 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
* Diagnosis of diabetes (type 1 or type 2)
* Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
* Obesity induced by endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Treatment Emergent Adverse Events
Timeframe: Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)