A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM) (NCT06660173) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
United States409 participantsStarted 2024-11-07
Plain-language summary
The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)
* Type 2 diabetes for ≥6 months according to the World Health Organization classification
* HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory
* Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening
* Body mass index of 23 to 50 kilograms per square meter
Exclusion Criteria:
* Type 1 diabetes
* Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening
* Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
* History of acute or chronic pancreatitis
* Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
* Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure.…
What they're measuring
1
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)