Diabetes Mellitus, Type 2 study: Maridebart cafraglutide vs Semaglutide
Official title Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
ClinicalTrials.gov ID: NCT07866066
What this study is testing
What is Maridebart cafraglutide?
Maridebart cafraglutide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for diabetes mellitus, type 2.
Also referred to as AMG 133, MariTide.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
- Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with...
- Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m\^2) at 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 mellitus except T2D or past...
- Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
- Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
- One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic...
- History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- Self-reported change in body weight \> 5% within 90 days before screening.
See the full eligibility criteria
- HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
- Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a...
- Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m\^2) at screening.
- Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.
- Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
- Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
- One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
- History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- Self-reported change in body weight \> 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight...
- liposuction and/or abdominoplasty that was performed \> 1 year before screening.
- laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed \> 1 year before screening.
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Pompano Beach, Florida, United States
- Winter Park, Florida, United States
- Arlington, Virginia, United States
- Redmond, Washington, United States
- Vancouver, British Columbia, Canada
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Miami, Florida, United States; Miami Lakes, Florida, United States; Pompano Beach, Florida, United States; Winter Park, Florida, United States; Arlington, Virginia, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.