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Taking people in ChinaPhase 3

Tests maridebart cafraglutide in heart failure and obesity

Tests a drug added to usual care in adults with heart failure and obesity.

Key facts

Who runs it
Amgen
Where
Baotou, Beijing, Changchun, Changsha, Changzhou, Chengdu, Chifeng, Chongqing, Daqing, Guangzhou, Haikou, Hangzhou, Harbin, Hefei, Hengyang, Jinan, Kaifeng, Lishui, Luoyang, Nanchang, Nanjing, Pingxiang, Qinhuangdao, Shanghai, Shenyang, Shijiazhuang, Siping, Tai’an, Taiyuan, Tianjin, Wuhan, Wuxi, Xi'an, Xi’an, Yuncheng, and Zhengzhou, ChinaSee the 55 sitesAlso in 34 other countries, 629 sites
Trial code
Registry title
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Status
Recruiting
Phase
Phase 3
People taking part
5,056 people, planned
Started
25 Jun 2025
Expected to end
29 Sept 2030
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Maridebart cafraglutide
  • Placebo
Record updated
29 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart failure and obesity. Their heart still pumps fairly well (ejection fraction above 40%).

Age
18 to 99 years
Sex
Men and women
Disease stage
Heart failure for at least 30 days, NYHA Class II-IV, treated with standard heart failure care. Left ventricular ejection fraction above 40% within 12 months before randomization.
Earlier treatment
People who used a GLP-1 receptor agonist, GIP agonist or antagonist, or amylin analog within 90 days before or during screening cannot join.
Biomarker or test result
BMI of 30.0 kg/m² or higher at randomization.

Main reasons for not taking part

  • Heart attack, heart valve surgery, bypass or other major heart surgery, or stroke within 60 days
  • Type 1 diabetes or any diabetes other than type 2
  • Hospitalized for sudden worsening of heart failure during screening
  • Personal or close family history of medullary thyroid cancer or MEN-2
  • Kidney function eGFR below 20 or on dialysis

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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 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
  • 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
  • Type 1 diabetes mellitus, or any type of diabetes with the exception of T2DM or history of gestational diabetes
  • Any personal lifetime history of, or family history(first-degree relative[s]) of medullary thyroid carcinoma or MEN-2
  • Acute or chronic hepatitis
  • History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the trial
  • 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
  • eGFR < 20 mL/min/1.73 m\^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening
  • 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
  • Hospitalized with acute decompensated HF at the time of or during the screening period
  • Calcitonin ≥ 50 ng/L (pg/mL) at screening

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 99 years old?

Where in China

Also in 34 other countries, 629 sites

  • First Affiliated Hospital of Baotou Hospital, InnerBaotou, ChinaTaking people
  • Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaTaking people
  • Beijing HospitalBeijing, ChinaTaking people
  • Fuwai Hospital Chinese Academy of Medical SciencesBeijing, ChinaTaking people
  • Peking University Third HospitalBeijing, ChinaTaking people
  • China-Japan Union Hospital of JiLin UniversityChangchun, ChinaTaking people
  • Jilin Province Peoples HospitalChangchun, ChinaTaking people
  • The First Bethune Hospital of Jilin UniversityChangchun, ChinaTaking people
  • The Second Hospital of Jilin UniversityChangchun, ChinaTaking people
  • The Second Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
  • The Third Hospital of ChangshaChangsha, ChinaTaking people
  • The Third Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
  • The First Peoples Hospital of ChangzhouChangzhou, ChinaTaking people
  • Chengdu Fifth Peoples HospitalChengdu, ChinaTaking people
  • Affiliated Hospital of Chifeng UniversityChifeng, ChinaTaking people
  • The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
  • Daqing Oilfield General HospitalDaqing, ChinaTaking people
  • Guangdong Provincial Peoples HospitalGuangzhou, ChinaTaking people
  • The Affiliated Hospital of Inner Mongolia Medical UniversityHaikou, ChinaTaking people
  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
  • The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
  • The First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaTaking people
  • The Second Hospital of Anhui Medical UniversityHefei, ChinaNo longer taking part
  • Hebei Petro China Central HospitalHengyang, ChinaTaking people
  • Jinan Central HospitalJinan, ChinaTaking people
  • Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
  • Huaihe Hospital of Henan UniversityKaifeng, ChinaTaking people
  • Lishui Central HospitalLishui, ChinaTaking people
  • Luoyang Third Peoples HospitalLuoyang, ChinaTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
  • The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
  • Zhongda Hospital Southeast UniversityNanjing, ChinaTaking people
  • Pingxiang Peoples HospitalPingxiang, ChinaTaking people
  • First Hospital of QinhuangdaoQinhuangdao, ChinaTaking people
  • Shanghai East HospitalShanghai, ChinaTaking people
  • Shanghai General HospitalShanghai, ChinaTaking people
  • Shanghai Tenth Peoples HospitalShanghai, ChinaTaking people
  • The Peoples Hospital of Liaoning ProvinceShenyang, ChinaTaking people
  • Zhongshan Hospital Affiliated to Dalian UniversityShenyang, ChinaTaking people
  • The First Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
  • The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaNo longer taking part
  • Siping City Center Peoples HospitalSiping, ChinaNo longer taking part
  • Tai'an City Central HospitalTai’an, ChinaTaking people
  • First Hospital of Shanxi Medical UniversityTaiyuan, ChinaTaking people
  • Shanxi Cardiovascular HospitalTaiyuan, ChinaTaking people
  • TEDA International Cardiovascular HospitalTianjin, ChinaTaking people
  • Tianjin Peoples HospitalTianjin, ChinaTaking people
  • The Third Peoples Hospital of Hubei ProvinceWuhan, ChinaTaking people
  • Wuxi Peoples HospitalWuxi, ChinaTaking people
  • Shaanxi Provincial Peoples HospitalXi'an, ChinaTaking people
  • The First Affiliated Hospital of Xi'an Medical UniversityXi'an, ChinaNo longer taking part
  • The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, ChinaTaking people
  • Yuncheng Central HospitalYuncheng, ChinaTaking people
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
  • Zhengzhou Central HospitalZhengzhou, ChinaTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Maridebart CafraglutideTreatment being tested

    Participants will receive maridebart cafraglutide subcutaneously (SC)

  • PlaceboPlacebo, for comparison

    Participants will receive placebo SC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Plain-language title
Tests maridebart cafraglutide in heart failure and obesityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07037459, who can take part
Record updated
29 October 2026