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Clinical Trials List

Protocol Number20230227
NCT Number(ClinicalTrials.gov Identfier)NCT07037459
Active

2025-11-14 - 2031-03-30

Not yet recruiting6

ICD-10I50.20

Unspecified systolic (congestive) heart failure

ICD-10I50.21

Acute systolic (congestive) heart failure

ICD-10I50.22

Chronic systolic (congestive) heart failure

ICD-10I50.23

Acute on chronic systolic (congestive) heart failure

ICD-10I50.30

Unspecified diastolic (congestive) heart failure

ICD-10I50.31

Acute diastolic (congestive) heart failure

ICD-10I50.32

Chronic diastolic (congestive) heart failure

ICD-10I50.33

Acute on chronic diastolic (congestive) heart failure

ICD-10I50.40

Unspecified combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.41

Acute combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.42

Chronic combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.43

Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure

ICD-10I50.9

Heart failure, unspecified

ICD-9428.0

Congestive heart failure

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    艾昆緯股份有限公司

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

Principal Investigator Chun-Yao Huang Division of Cardiovascular Diseases
Taipei Medical University Hospital

Co-Principal Investigator

  • Yung-Ta Kao Division of Cardiovascular Diseases
  • 鄭宇倫 Division of Cardiovascular Diseases
  • 陳志維 Division of Cardiovascular Diseases
  • 蕭卜源 Division of Cardiovascular Diseases
  • 洪元 Division of Cardiovascular Diseases
  • 陳彥舟 Division of Cardiovascular Diseases
  • Chien-Yi Hsu Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hsien Li Kao Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Shih-Hsien Sung Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Kuan-Cheng Chang Division of Cardiovascular Diseases
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Ping-Yen Liu
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Heart Failure With Preserved Ejection Fraction、 Heart Failure With Mildly Reduced Ejection Fraction Obesity

Objectives

In participants with confirmed normal systolic fractional-efficacy heart failure (HFpEF) and intermediate-range systolic fractional-efficacy heart failure (HFmrEF) and a body mass index (BMI) ≥ 30 kg/m2, maridebart cafraglutide was superior to placebo as an adjunct to standard treatment in the composite measure of heart failure (HF) events (hospitalization or emergency room visit for HF) or death due to cardiovascular (CV) disease.

Test Drug

subcutaneous injection

Active Ingredient

Maridebart cafraglutide (AMG 133)

Dosage Form

220

Dosage

21 mg/1 mL PFS, 35 mg/1 mL PFS, 70 mg/1 mL PFS, 140 mg/3 mL PFS, 210 mg/3 mL PFS, 350 mg/3 mL PFS

Endpoints

In participants with confirmed normal systolic fractional-efficacy heart failure (HFpEF) and intermediate-range systolic fractional-efficacy heart failure (HFmrEF) and a body mass index (BMI) ≥ 30 kg/m2, maridebart cafraglutide was superior to placebo as an adjunct to standard treatment in the composite measure of heart failure (HF) events (hospitalization or emergency room visit for HF) or death due to cardiovascular (CV) disease.

Inclution Criteria

Inclusion Criteria:

Age ≥ 18 years at the time of informed consent.
BMI ≥ 30.0 kg/m^2 at the time of 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 from the beginning of screening.
Elevated NT-proBNP.
Participants must have at least one of the following:

Structural heart disease within 12 months prior to screening OR
Documented hospitalization with a primary diagnosis of decompensated HF which required IV loop diuretic treatment > 30 days and < 12 months prior to randomization OR
Evidence of elevated filling pressures within 12 months before randomization.

Exclusion Criteria

Exclusion Criteria:

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 cardiovascular surgery, stroke.
HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
Any lifetime history of LVEF ≤ 40%.
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 retinopathy and/or macular edema.
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.
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 planned use during the conduct of the trial.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    5056 participants

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