A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Funct… (NCT07160257) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus
United States56 participantsStarted 2025-08-05
Plain-language summary
The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.
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:
* Informed consent before initiation of any study-specific activities/procedures.
* Male or female participants aged ≥ 18 and ≤ 70 years at the time of signing informed consent.
* Body mass index ≥ 23.0 kg/m\^2 (Asian participants only) or ≥ 25 and ≤ 45 kg/m\^2 at screening.
* Diagnosis of T2DM at least 6 months before screening based on the WHO classification.
* Treatment of T2DM for at least 3 months prior to screening with diet and exercise and a stable dose of metformin (either immediate release or extended release), with or without a stable dose of 1 additional OAM other than metformin.
Exclusion Criteria:
* Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus (except T2DM or history of gestational diabetes).
* History of proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment.
* One or more episodes of severe hypoglycemia (Level 3 hypoglycemia as defined by the American Diabetes Association classification criteria) within 6 months before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
* Has modified diet or adopted any nutritional lifestyle modifications within 3 months prior to screening, as assessed by the investigator (or designee) based on participant self-report.
* History of malignancy within the last 5 years before screening (e…
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.
1This trial is in Phase 1, which is typically focused on early safety and how the drug works in the body — what does that mean for what's actually known about maridebart cafraglutide's safety and effectiveness in people with Type 2 diabetes at this point?
2The trial is measuring something called an M-value from a hyperinsulinemic-euglycemic clamp test — can you explain what that procedure involves and whether it would be physically demanding or risky for someone in my situation?
3Since the study is listed as 'active not recruiting,' I wouldn't be able to enroll right now — but based on what this trial is trying to learn about insulin sensitivity and beta-cell function, are there other similar studies or approaches you'd recommend I consider instead?
4This trial looks at how the drug affects insulin sensitivity and beta-cell function over 25 weeks — given where my diabetes currently stands, would waiting for results from early-phase trials like this one make more sense than pursuing available standard treatments now?
5What do you know about maridebart cafraglutide as a drug class, and how does its mechanism of action compare to diabetes medications I might already be taking or be a candidate for?
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
Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25