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)
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)
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). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.
Inclusion 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 or chronic myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, uncorrected primary valvular heart disease, clinically significant congenital heart disease.
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):
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 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.
medinfo@amgen.com866-572-6436
Elkhart, Indiana 46514, United States
Ann Arbor, Michigan 48109-5853, United States
Maplewood, Minnesota 55109, United States
Powell, Tennessee 37849, United States
CABA, Buenos Aires 1178, Argentina
CABA, Buenos Aires C1056ABI, Argentina
CABA, Buenos Aires C1407GTN, Argentina
CABA, Buenos Aires C1425AGC, Argentina
CABA, Buenos Aires C1426ABP, Argentina
CABA, Buenos Aires C1431FWO, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1425, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1061AAT, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1128AAF, Argentina
Morón, Buenos Aires B1708EPE, Argentina
Ramos Meija, Buenos Aires B1704ETD, Argentina
San Nicolás de los Arroyos, Buenos Aires B2900DMH, Argentina
Rosario, Santa Fe Province S2000CVD, Argentina
Rosario, Santa Fe Province S2000PBJ, Argentina
San Miguel de Tucumán, Tucumán Province T4000ICL, Argentina
Yvoir, 5530, Belgium
Vitória, Espírito Santo 29055-450, Brazil
Belo Horizonte, Minas Gerais 30150-320, Brazil
Belo Horizonte, Minas Gerais 31110-580, Brazil
Porto Alegre, Rio Grande do Sul 91350-280, Brazil
Campinas, São Paulo 13092-133, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
São Paulo, São Paulo 05403-900, Brazil
Burgas, 8000, Bulgaria
Plovdiv, 4001, Bulgaria
Sofia, 1233, Bulgaria
Sofia, 1309, Bulgaria
Veliko Tarnovo, 5000, Bulgaria
Cambridge, Ontario N1R 7R1, Canada
North York, Ontario M6B 3H7, Canada
Independencia, Santiago Metropolitan, Chile
Beijing, Beijing Municipality 100037, China
Beijing, Beijing Municipality 100050, China
Harbin, Heilongjiang 150001, China
Nanjing, Jiangsu 210011, China
Chongqing, Sichuan 400010, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310016, China
Barranquilla, Atlántico 080002, Colombia
Manizales, Caldas Department 170004, Colombia
Havirov - Mesto, 736 01, Czechia
Prague, 101 00, Czechia
Praha 5 - Smichov, 150 00, Czechia
Bron, 69677, France
Dijon, 21000, France
Lille, 59037, France
Montpellier, 34090, France
Toulon, 83056, France
Tours, 37044, France
Dresden, 01099, Germany
Wermsdorf, 04779, Germany
Athens, 12462, Greece
Shatin, New Territories, Hong Kong
Nyíregyháza, 4400, Hungary
Szentes, 6600, Hungary
Cortona AR, 52044, Italy
Naples, 80131, Italy
Toyoake-shi, Aichi-ken 470-1192, Japan
Takarazuka-shi, Hyōgo 665-0873, Japan
Sagamihara-shi, Kanagawa 252-5188, Japan
Kitaazumi-gun, Nagano 399-8695, Japan
Fujinomiya-shi, Shizuoka 418-0076, Japan
Hachioji-shi, Tokyo 192-0918, Japan
Higashiyamato-shi, Tokyo 207-0014, Japan
Shinagawa-ku, Tokyo 140-8522, Japan
Suginami-ku, Tokyo 168-0065, Japan
Yonago-shi, Tottori 683-8605, Japan
Culiacán, Sinaloa 80230, Mexico
Gdynia, 81-423, Poland
Lodz, 90-549, Poland
Rzeszów, 35-055, Poland
Tychy, 43-100, Poland
Warsaw, 02-507, Poland
Wroclaw, 50-556, Poland
Almada, 2805-267, Portugal
Lisbon, 1449-005, Portugal
Lisbon, 1649-035, Portugal
Matosinhos Municipality, 4464-513, Portugal
Seongnam-si, Gyeonggi-do, 13620, South Korea
Wonju-si, Gangwon-do, 26426, South Korea
Las Palmas de Gran Canaria, Canary Islands 35010, Spain
Afyonkarahisar, 03218, Turkey (Türkiye)
Istanbul, 34307, Turkey (Türkiye)
Istanbul, 34668, Turkey (Türkiye)
Newcastle upon Tyne, NE7 7DN, United Kingdom
Portadown, Craigavon, BT63 5QQ, United Kingdom