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Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Subjects With Type 2 Diabetes Mellitus
EU CTIS ID: 2024-513539-25-00
What this study is testing
To assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has provided informed consent before initiation of any study-specific activities/procedures.
- Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years).
- BMI of ≥ 23 to ≤ 50 kg/m2 at screening
- Diagnosis of T2DM at least 180 days before screening based on the World Health Organization (WHO) classification
- HbA1c at screening of ≥ 7.0% (53.0 mmol/mol) and ≤ 10.5% (91.3 mmol/mol).
- Treatment of T2DM with a stable dose of metformin (either immediate release or extended release, ≥ 1000 mg/day and not more than the locally approved dose) with or without an SGLT2-inhibitor for at least 90 days before screening.
You likely can't join if
- Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes, except T2DM.
- Fasting glucose > 270 mg/dL (15.0 mmol/L) at screening.
- History of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment (based on a fundoscopic examination performed by an ophthalmologist or another suitably qualified healthcare provider [eg, optometrist] within 90 days before screening or in the period between screening and randomization).
- Change in body weight > 5 kg within 90 days before screening, per subject report or medical records.
- One or more episode of severe hypoglycemia within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
See the full eligibility criteria
- Subject has provided informed consent before initiation of any study-specific activities/procedures.
- Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years).
- BMI of ≥ 23 to ≤ 50 kg/m2 at screening
- Diagnosis of T2DM at least 180 days before screening based on the World Health Organization (WHO) classification
- HbA1c at screening of ≥ 7.0% (53.0 mmol/mol) and ≤ 10.5% (91.3 mmol/mol).
- Treatment of T2DM with a stable dose of metformin (either immediate release or extended release, ≥ 1000 mg/day and not more than the locally approved dose) with or without an SGLT2-inhibitor for at least 90 days before screening.
- Subject is able and willing to comply with the requirements of the study protocol including SMBG and completion of subject diary
- Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes, except T2DM.
- Fasting glucose > 270 mg/dL (15.0 mmol/L) at screening.
- History of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment (based on a fundoscopic examination performed by an ophthalmologist or another suitably qualified healthcare provider [eg, optometrist] within 90 days before screening or in the period between screening and randomization).
- Change in body weight > 5 kg within 90 days before screening, per subject report or medical records.
- One or more episode of severe hypoglycemia within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Korea, Republic of
- Japan
- United States
- Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Korea, Republic of; Japan; United States; Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.