BridgeMD
New treatment option for Heart Failure With Preserved Ejection Fraction
Official title Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
ClinicalTrials.gov ID: NCT07037459
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 heart failure with preserved ejection fraction.
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
- This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE).
- Phase 3: a large, late-stage study
- This is a blinded 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 to 99
You may be able to join if
- Age ≥ 18 years at the time of informed consent.
- BMI ≥ 30.0 kg/m\^2 at randomization.
- HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.
- Managed with HF standard of care therapies.
- Left ventricular ejection fraction (LVEF) of \> 40% within 12 months before randomization.
You likely can't join if
- History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary...
- HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade...
- Hospitalized with acute decompensated HF at the time of or during the screening period.
- Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
- For participants with a prior diagnosis of T2DM (including those diagnosed during screening):
- HbA1c \> 10.0% (86 mmol/mol) at screening
See the full eligibility criteria
- Age ≥ 18 years at the time of informed consent.
- BMI ≥ 30.0 kg/m\^2 at randomization.
- HF diagnosed for at least 30 days with New York Heart Association (NYHA) Class II-IV at the time of informed consent.
- Managed with HF standard of care therapies.
- Left ventricular ejection fraction (LVEF) of \> 40% within 12 months before randomization.
- History of any of the following within 60 days prior to or during screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major...
- HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular...
- Hospitalized with acute decompensated HF at the time of or during the screening period.
- Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
- For participants with a prior diagnosis of T2DM (including those diagnosed during screening):
- HbA1c \> 10.0% (86 mmol/mol) at screening
- Uncontrolled diabetes requiring immediate therapy
- History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization
- One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness
- History or presence of either proliferative diabetic retinopathy, or diabetic maculopathy, or severe non-proliferative diabetic retinopathy; or currently receiving or planning to receive treatment for diabetic...
- SBP ≥ 180 mmHg during the screening period, or on three or more blood pressure-lowering drugs with a SBP \> 160 mmHg during the screening period (including day 1 prior to randomization).
- History of chronic pancreatitis or acute pancreatitis in the 180 days before screening or during the screening period.
- Any personal lifetime history of, or family history(first-degree relative(s)) of medullary thyroid carcinoma or MEN-2.
- eGFR \< 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
- Calcitonin ≥ 50 ng/L (pg/mL) at screening.
- Acute or chronic hepatitis.
- Any of the following psychiatric history:
- History of unstable major depressive disorder or other severe psychiatric disorder within 2 years prior to screening or during the screening period
- Lifetime history of suicide attempt
- History of non-suicidal self-injury within 5 years prior to screening or during the screening period.
- History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial.
- Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days prior to or during the screening period or...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Dothan, Alabama, United States
- Fairhope, Alabama, United States
- Huntsville, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Yuma, Arizona, United States
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Covina, California, United States
- Huntington Beach, California, United States
- Inglewood, California, United States
- Newport Beach, California, United States
- Northridge, California, United States
- Orange, California, United States
- Pomona, California, United States
- San Diego, California, United States
- Santa Rosa, California, United States
- Stockton, California, United States
- Stamford, Connecticut, United States
+ 484 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Dothan, Alabama, United States; Fairhope, Alabama, United States; Huntsville, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States and 498 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.