Testing NNC0487-0111 Against Placebo in Adults With Heart Failure and Excess Weight
Tests the weekly injection NNC0487-0111 against placebo in adults with heart failure and obesity.
Plain-language title generated from the registry record
Registry title: A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
Key facts
- Where
- Bunkyo-ku, Tokyo, Chiba-shi,Chiba, Chikushino-shi, Fukuoka, Fuchu-shi,Tokyo, Fukuoka-shi, Fukuoka, Higashiosaka-shi, Osaka, Himeji-shi, Hyogo, Hyōgo, Ibaraki, Kanagawa, Kasugai-shi, Aichi, Kofu-shi, Yamanashi, Kyoto-shi, Kyoto, Maebashi-shi, Gunma, Matsumoto-shi, Nagano, Miura-gun, Kanagawa, Morioka-shi, Iwate, Nagasaki, Osaka, Osaka-Shi, Osaka, Ota-shi, Gunma, Sapporo-shi, Hokkaido, Shinjuku-ku, Tokyo, Shizuoka, Takamatsu-shi, Kagawa, Tokyo, Tomakomai-Shi, Hokkaido, Toshima-ku,Tokyo, Uwajima-shi, Wakayama-shi, Wakayama, and Yokohama-shi，Kanagawa, JapanSee the 32 sites
- Phase
- Phase 3
Where in Japan
- NIPPON MEDICAL SCHOOL HOSPITAL_Cardiovascular medicineBunkyo-ku, Tokyo, JapanNot yet recruiting
- National Hospital Organization Chiba Medical Center_Cardiovascular MedicineChiba-shi,Chiba, JapanTaking people
- Fukuokaken Saiseikai Futsukaichi Hospital_Cardiovascular MedicineChikushino-shi, Fukuoka, JapanTaking people
- SAKAKIBARA HEART INSTITUTE_CardiologyFuchu-shi,Tokyo, JapanTaking people
- Fukuoka Wajiro Hospital_CardiologyFukuoka-shi, Fukuoka, JapanTaking people
- Higashiosaka City Medical Center_Cardiovascular MedicineHigashiosaka-shi, Osaka, JapanTaking people
- Hyogo Prefectural HarimaHimeji General Medical Center_CardiologyHimeji-shi, Hyogo, JapanTaking people
- Higashi Takarazuka Satoh Hospital_CardiologyHyōgo, JapanTaking people
- National Hospital Organization Mito Medical Center_Cardiovascular medicineIbaraki, JapanTaking people
- Tsuchiura Kyodo General Hospital_Internal MedicineIbaraki, JapanTaking people
- Yokohama City University Medical Center_Cardiovascular CenterKanagawa, JapanTaking people
- Kasugai Municipal Hospital_Cardiovascular MedicineKasugai-shi, Aichi, JapanTaking people
- Yamanashi Prefectural Central Hospital_CardiologyKofu-shi, Yamanashi, JapanTaking people
- National Hospital Organization Kyoto Medical Center_CardiologyKyoto-shi, Kyoto, JapanTaking people
- Gunma University Hospital_Cardiovascular MedicineMaebashi-shi, Gunma, JapanNot yet recruiting
- Shinshu University Hospital__Department of CardiologyMatsumoto-shi, Nagano, JapanNot yet recruiting
- Hayama Heart Center_CardiologyMiura-gun, Kanagawa, JapanTaking people
- Iwate Prefectural Central Hospital_CardiologyMorioka-shi, Iwate, JapanNot yet recruiting
- Nagasaki Harbor Medical Center_Cardiovascular medicineNagasaki, JapanTaking people
- Osaka General Medical Center_CardiologyOsaka, JapanTaking people
- Osaka Metropolitan University Hospital_Cardiovascular MedicineOsaka-Shi, Osaka, JapanNot yet recruiting
- Ota Memorial Hospital_CardiologyOta-shi, Gunma, JapanTaking people
- Mita Clinic of Internal Medicine and Cardiology_CardiologySapporo-shi, Hokkaido, JapanTaking people
- National Center for Global Health and Medicine_CardiologyShinjuku-ku, Tokyo, JapanTaking people
- JA Shizuoka Kohseiren Enshu Hospital_Internal MedicineShizuoka, JapanNot yet recruiting
- Kagawa Prefectural Central Hospital_Cardiovascular MedicineTakamatsu-shi, Kagawa, JapanTaking people
- Tokyo-Eki Center-building Clinic_Internal MedicineTokyo, JapanTaking people
- Tomakomai City Hospital_CardiologyTomakomai-Shi, Hokkaido, JapanTaking people
- Sekino Hospital_Internal MedicineToshima-ku,Tokyo, JapanTaking people
- Uwajima City Hospital_CardiologyUwajima-shi, JapanTaking people
- Japanese Red Cross Wakayama Medical Center_Department of CardiologyWakayama-shi, Wakayama, JapanTaking people
- Yokohama City University Hospital_Cardiovascular MedicineYokohama-shi，Kanagawa, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07567001EU 2025-523717-29-00
- Record updated
- 18 August 2026
- Original description
This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.Read full original descriptionShow less
Efficacy and Safety of NNC0487-0111 Compared to Placebo on Morbidity and Mortality in People With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.
Inclusion: Body Mass Index (BMI) greater than or equal to (>=) 30 kilograms per square metre (kg/m\^2) at screening; Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator; For participants with Type 2 Diabetes (T2D) at screening:; Diagnosed with T2D >= 30 days before screening.
Exclusion: MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization; requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening; Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination; HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree; Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as:; Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism); Glycaemia-related:; History of type 1 diabetes; Glycated haemoglobin (HbA1c) greater than (>) 10 percent (%) (86 [millimoles per mole] mmol/mol) as measured by local or central laboratory at screening.