Taking people in TürkiyePhase 3
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.
Key facts
- Who runs it
- Novo Nordisk A/S
- Where
- Adana, Adapazarı/Sakarya, Afyonkarahisar, Altınordu/Ordu, Ankara, Antalya, Bayraklı/İzmir, Bursa, Çanakkale/Türkiye, Canik/Samsun, Eskişehir, Istanbul, Izmir, Kayseri, Keçiören/Ankara, Kocaeli, Kütahya, Malatya, Merkez/elaziğ, Mersin, Muratpasa/ Antalya, Yakutiye / Erzurum, Yenimahalle/Ankara, and Yuregir/Adana, TürkiyeSee the 31 sitesAlso in 26 other countries, 799 sites
- Trial code
- NCT07567001
- EU 2025-523717-29-00
- U1111-1328-2701
- Registry title
- A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 5,610 people, planned
- Started
- 11 May 2026
- Expected to end
- 15 Aug 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- NNC0487-0111
- Placebo
- Record updated
- 18 August 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 (class II-IV, stable) and a body mass index of 30 or more. It tests NNC0487-0111 against placebo given by weekly injection.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Heart failure with New York Heart Association class II-IV, in stable condition at screening. People with type 2 diabetes must have been diagnosed at least 30 days before screening.
- Biomarker or test result
- Body Mass Index (BMI) of 30 kg/m^2 or more at screening. HbA1c above 10 % (86 mmol/mol) at screening excludes people.
Main reasons for not taking part
- Heart attack, stroke, unstable angina or worsening heart failure needing hospital stay or intravenous diuretics within 30 days before screening
- Heart failure caused by certain heart muscle, pericardium or valve diseases
- Severe lung disease, such as primary pulmonary hypertension or severe COPD
- History of type 1 diabetes
- Diabetic eye disease treated or expected to need treatment within 180 days
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Türkiye
Also in 26 other countries, 799 sites
- Adana Şehir Eğitim ve Araştırma HastanesiAdana, TürkiyeContact: Novo NordiskTaking people
- Sakarya Eğitim ve Araştırma Hastanesi- DahiliyeAdapazarı/Sakarya, TürkiyeContact: Novo NordiskTaking people
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- KardiyolojiAfyonkarahisar, TürkiyeContact: Novo NordiskTaking people
- Ordu Üniversitesi Eğitim ve Araştırma Hastanesi- KardiyolojiAltınordu/Ordu, TürkiyeContact: Novo NordiskTaking people
- Ankara Bilkent Şehir Hastanesi-DahiliyeAnkara, TürkiyeContact: Novo NordiskTaking people
- Ankara Bilkent Şehir Hastanesi-KardiyolojiAnkara, TürkiyeContact: Novo NordiskTaking people
- Akdeniz Üniversitesi Hastanesi-KardiyolojiAntalya, TürkiyeContact: Novo NordiskNot yet recruiting
- İzmir Şehir Hastanesi- KardiyolojiBayraklı/İzmir, TürkiyeContact: Novo NordiskTaking people
- Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-KardiyolojiBursa, TürkiyeContact: Novo NordiskTaking people
- Çanakkale Onsekiz Mart Üniversitesi Sağlık Araştırma ve Uygulama Hastanesi- KardiyolojiÇanakkale/Türkiye, TürkiyeContact: Novo NordiskTaking people
- Samsun Şehir Hastanesi-KardiyolojiCanik/Samsun, TürkiyeContact: Novo NordiskTaking people
- Eskişehir Osmangazi Üniversitesi Hastanesi- KardiyolojiEskişehir, TürkiyeContact: Novo NordiskTaking people
- Eskişehir Şehir Hastanesi- KardiyolojiEskişehir, TürkiyeContact: Novo NordiskTaking people
- Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi EAH- KardiyolojiIstanbul, TürkiyeContact: Novo NordiskNot yet recruiting
- İstanbul Üniversitesi-Cerrahpaşa Kardiyoloji EnstitüsüIstanbul, TürkiyeContact: Novo NordiskTaking people
- Marmara Üniversitesi Pendik EAH- KardiyolojiIstanbul, TürkiyeContact: Novo NordiskTaking people
- Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAHIstanbul, TürkiyeContact: Novo NordiskTaking people
- Dokuz Eylül Üniversitesi Araştırma Uygulama Hastanesi-KardiyolojiIzmir, TürkiyeContact: Novo NordiskTaking people
- İzmir Atatürk Eğitim Ve Araştırma Hastanesi- KardiyolojiIzmir, TürkiyeContact: Novo NordiskTaking people
- Erciyes Üniversitesi Hastanesi- KardiyolojiKayseri, TürkiyeContact: Novo NordiskTaking people
- Kayseri Şehir Hastanesi-KardiyolojiKayseri, TürkiyeContact: Novo NordiskTaking people
- Gülhane Eğitim ve Araştırma Hastanesi- KardiyolojiKeçiören/Ankara, TürkiyeContact: Novo NordiskTaking people
- Kocaeli Üniversitesi Hastanesi- KardiyolojiKocaeli, TürkiyeContact: Novo NordiskTaking people
- Kütahya Şehir Hastanesi-KardiyolojiKütahya, TürkiyeContact: Novo NordiskTaking people
- İnönü Üniversitesi Turgut Özal Tıp Merkezi - KardiyolojiMalatya, TürkiyeContact: Novo NordiskTaking people
- Fırat Üniversitesi Hastanesi- KardiyolojiMerkez/elaziğ, TürkiyeContact: Novo NordiskTaking people
- Mersin Üniversitesi Hastanesi- KardiyolojiMersin, TürkiyeContact: Novo NordiskTaking people
- Antalya Eğitim ve Araştırma Hastanesi- KardiyolojiMuratpasa/ Antalya, TürkiyeContact: Novo NordiskTaking people
- Atatürk Üniversitesi Araştırma Hastanesi-KardiyolojiYakutiye / Erzurum, TürkiyeContact: Novo NordiskNot yet recruiting
- Ankara Etlik Şehir Hastanesi- KardiyolojiYenimahalle/Ankara, TürkiyeContact: Novo NordiskTaking people
- Adana Şehir Eğitim ve Araştırma Hastanesi-DahiliyeYuregir/Adana, TürkiyeContact: Novo NordiskTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- NNC0487-0111Treatment being tested
Participants will receive NNC0487-0111 subcutaneously (s.c.) in a dose escalating manner once weekly.
- PlaceboPlacebo, for comparison
Participants will receive placebo matched to NNC0487-011 s.c. once weekly.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Testing NNC0487-0111 Against Placebo in Adults With Heart Failure and Excess WeightGenerated 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.
- Record updated
- 18 August 2026