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Protocol Number20230227
Active

2025-11-14 - 2031-03-30

Phase III

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 (MARITIMEHF)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Amgen Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Ping-Yen Liu Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

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 Chun-Yao Huang
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity

Objectives

To demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care on the composite endpoint of heart failure (HF) events (hospitalization for HF or urgent HF visits) or death from cardiovascular (CV) disease in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) and a body mass index (BMI) ≥ 30 kg/m2

Test Drug

Subcutaneous (SC) injection

Active Ingredient

Maridebart cafraglutide (AMG 133)

Dosage Form

injection

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

To demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care on the composite endpoint of heart failure (HF) events (hospitalization for HF or urgent HF visits) or death from
cardiovascular (CV) disease in participants with HF with preserved ejection fraction (HFpEF) and HF
with mildly reduced ejection fraction (HFmrEF) and a body mass index (BMI) ≥ 30 kg/m2

Inclution Criteria

Participants are eligible to be included in the study only if all the following criteria apply:
101 Participant has provided informed consent before initiation of any study-specific
activities/procedures
102 Age ≥ 18 years (or  legal age within the country if it is older than 18 years)
103 BMI ≥ 30 kg/m2 at screening
104 HF diagnosed for at least 30 days before screening with NYHA Class II-IV at
screening
105 Managed with HF standard of care therapies consistent with regional clinical
practice guidelines stable for at least 14 days according to investigator judgment
106 Documented LVEF of  40% measured by any modality within the last
12 months, at the latest at screening; if several values are available, the most
recent one shall be reported. If LVEF was not measured in the past 12 months,
a new measurement may be done at screening. Left ventricular ejection fraction
must be obtained at least 90 days after any myocardial infarction (MI)
107 Elevated NT-proBNP > 300 pg/mL for patients in sinus rhythm, or > 600 pg/mL
for participants in active atrial fibrillation (AF) or atrial flutter (AFL), at screening
108 Participants must have at least one of the following:
1) Structural heart disease criteria documenting at least 1 of the following on
echocardiogram within 12 months before randomization:
a. Average E/é ≥ 15
b. Left atrial (LA) enlargement (LA width ≥ 3.8 cm, or LA length ≥ 5.0 cm, or
LA area ≥ 20.0 cm2, or LA volume ≥ 55 mL, or LA volume index
≥ 34 mL/m2)
c. Left ventricular (LV) hypertrophy with septal thickness, or posterior wall
thickness ≥ 1.2 cm
OR
2) Documented hospitalization with a primary diagnosis of decompensated HF
(documentation for HF hospitalization must be provided in the source
documents) which required IV loop diuretic treatment, within 12 months before
randomization
OR
3) Evidence of elevated filling pressures within 12 months before randomization:
Mean pulmonary wedge pressure ≥ 15 mmHg, or left ventricular end diastolic
pressure (LVEDP) ≥ 15 mmHg documented during catheterization at rest, or PA
diastolic pressure measured by implantable monitor ≥ 15 mmHg, or pulmonary
wedge pressure or LVEDP ≥ 25 mmHg documented during catheterization at
exercise
109 For participants with a prior diagnosis of T2DM at screening:
• Treatment of T2DM with diet, exercise, and/or glucose-lowering
medications according to local label with stable dosing for at least 30 days
before randomization
▪ Oral glucose-lowering drugs: unchanged drug(s), dose, and dosing
frequency as judged by the investigator
▪ Insulin: unchanged regimen with stable total daily insulin dose as
judged by the investigator

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
Disease Related
201 History of any of the following within 60 days before screening: Type I
(spontaneous) MI (type II MIs are not an exclusion criterion), valvular
replacement or repair, coronary revascularization, coronary artery bypass graft
surgery or other major cardiovascular surgery, stroke
202 Heart failure due to any of the following: hypertrophic cardiomyopathy
(obstructive and non obstructive), infiltrative cardiomyopathy (including cardiac
sarcoid, lymphoma, cardiac amyloid, endomyocardial fibrosis), active
myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right
ventricular or left ventricular cardiomyopathy/dysplasia, or uncorrected primary
valvular heart disease, or clinically significant congenital heart disease
203 Any lifetime history of LVEF ≤ 40%
204 Currently hospitalized with acute decompensated HF at the time of screening
205 Hospitalization with a primary diagnosis of decompensated HF which required IV
loop diuretic treatment, within 30 days before screening
206 Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or
history of gestational diabetes
207 For participants with a prior diagnosis of T2DM at screening:
• HbA1c > 10.0% (86 mmol/mol) at screening
• Uncontrolled diabetes requiring immediate therapy at randomization in the
judgement of the investigator
• History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months
before screening
• One or more episodes of severe hypoglycemia within 6 months before
screening and/or history of hypoglycemia unawareness
• History of proliferative diabetic retinopathy, diabetic maculopathy, or severe
non-proliferative diabetic retinopathy. A dilated fundoscopic examination or
digital fundus photography with specified camera for non-dilated examination,
performed by an ophthalmologist or another suitably qualified healthcare
provider (eg, optometrist) within the following timeframe before screening or
in the period between screening and randomization is required to verify
eligibility criteria:
− For participants without diabetic retinopathy on the most current
fundoscopy exam, a fundoscopy exam should be performed within
12 months before screening
− For participants with mild or moderate non-proliferative retinopathy on the
most current fundoscopy exam, a fundoscopy exam should be performed
within 6 months before screening.
If the participant has experienced worsening of visual function since the last
examination, then the examination must be repeated before determining
eligibility for randomization. Refer to Section 8.4.5.3 for details.
Note: Exclusionary glucose-lowering medications can be found in Exclusion
Criteria 224 and 225 below
Note: Participants without a previous diagnosis of T2DM who have an HbA1c ≥
6.5% at screening can be rescreened after 3 months if glycemic status is
controlled and on stable therapy
208 Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or on three or more blood
pressure-lowering drugs with a SBP > 160 mmHg
Other Medical Conditions
209 History of chronic pancreatitis
210 History of acute pancreatitis in the 180 days before screening
211 Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma
(MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
212 Estimated Glomerular Filtration Rate (eGFR) < 20 mL/min/1.73 m2 according to
the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
creatinine (Cr)-cystatin C equation or receiving dialysis at screening
213 Obesity induced by specific endocrinologic disorders or monogenetic or
syndromic forms of obesity
214 Planned bariatric surgery at the time of screening, or within 180 days of
screening
215 Calcitonin ≥ 50 ng/L (pg/mL) at screening
216 Acute or chronic hepatitis; signs and symptoms of any liver disease other than
Metabolic-Associated Steatotic Liver Disease; or alanine aminotransferase (ALT)
> 3.0 x the upper limit normal (ULN), or total bilirubin (TBL) > 1.8 x ULN (for
participants with a known diagnosis of Gilbert syndrome, direct bilirubin should
be used instead of TBL)
217 Clinically significant gastric-emptying abnormality (including, but not limited to
gastroparesis and gastric outlet obstruction)
218 Any of the following psychiatric history:
• History of unstable major depressive disorder (MDD) or other severe
psychiatric disorder within 2 years before screening
− Participants with MDD or other psychiatric disorder whose disease state
is considered stable for the past 2 years before screening and are
expected to remain stable throughout the study, in the opinion of the
investigator, may be eligible
• Lifetime history of suicide attempt
• History of non-suicidal self-injury (NSSI) within 5 years before screening.
NSSI is a self-inflicted injury that causes pain or superficial damage (eg,
cutting, carving, or burning of the skin) as a way to cope with emotional pain,
sadness, anger, and stress and is not intended to cause death
219 History of malignancy within the last 5 years before screening (except for the
following treated with curative intent: non-melanoma skin cancer, breast ductal
carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ)
220 Recipient of heart transplant or any other major organ transplant (eg, lung, liver,
bone marrow, renal), listed for heart transplant, or anticipated to receive chronic
mechanical circulatory support or heart transplantation within 12 months from
randomization
221 Severe, concomitant disease that is expected to reduce life expectancy to
< 1 year
222 History of any other condition (including, but not limited to known drug or alcohol
abuse and eating disorders) that, in the opinion of the investigator, may preclude
the participant from following the protocol and completing the study.
223 Any disorder, unwillingness, or inability, not covered by any of the other exclusion
criteria, which in the investigator’s opinion, might jeopardize the participant’s
safety or compliance with the protocol
Prior/Concomitant Therapy
224 Use of any GLP-1 RA, GIP agonists or antagonists, or amylin analogs within 90
days before randomization or planned use during the conduct of the study
225 Treatment with continuous SC insulin therapy (insulin pump) at screening or
participants on intensified insulin therapy who practice carbohydrate counting for
bolus insulin dose adjustment
226 Use within 90 days before randomization of medications prescribed for weight
loss
227 In the opinion of the investigator, use within 90 days before randomization of
medications that may cause significant weight gain
Prior/Concurrent Clinical Study Experience
228 Currently receiving treatment in another investigational device or drug study, or
less than 90 days (or 5 half-lives, whichever is longer) since ending treatment in
another investigational device or drug study(ies). This does not apply to other
investigational procedures or participation in observational research studies
229 Previous participation in a study that includes maridebart cafraglutide or
AMG 598
Other Exclusions
230 Participants of childbearing potential unwilling to use protocol-specified method
of contraception during treatment and for an additional 16 weeks after the last
dose of investigational product. Refer to Section 11.5 (Appendix 5) for additional
contraceptive information
231 Participants who are breastfeeding or who plan to breastfeed while on study
through 16 weeks after the last dose of investigational product
232 Participants planning to become pregnant while on study through 16 weeks after
the last dose of investigational product
233 Participants of childbearing potential with a positive pregnancy test assessed at
screening and/or day 1 before randomization
234 Participant with known sensitivity to any of the products or components to be
administered during dosing
235 Participant likely to not be available to complete all protocol-required study visits
or procedures, and/or to comply with all required study procedures (eg, Clinical
Outcome Assessments) to the best of the participant and investigator’s
knowledge
236 Investigative site personnel directly affiliated with the study and/or their
immediate family (ie, spouse, parent, child, or sibling, whether biological or
legally adopted)

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    5056 participants

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