A Study to Learn About How Safe Nitroglycerin is and How it Affects the Body When Taken Along With Nurandociguat in People With Coronary Artery Disease

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Stable Coronary Artery Disease

In brief

This study is designed to find out how safe nitroglycerin is and how it affects the body when it is taken together with another medicine called nurandociguat in people who have coronary artery disease (CAD). CAD is a condition where the arteries that supply blood to the heart become narrowed or blocked, often causing chest pain or even heart attacks. Many people with CAD also have chronic kidney disease (CKD), a long-term condition where the kidneys do not work as well as they should. People with CAD often use nitroglycerin to help improve blood flow to the heart. Nurandociguat is a new medicine being studied to help people with CKD by widening blood vessels and improving blood flow. Both nitroglycerin and nurandociguat work in similar ways in the body, so taking them together could have a stronger effect on blood vessels. This might lead to a sudden drop in blood pressure or other side effects. The main goal of this study is to learn how safe it is to use nitroglycerin and nurandociguat together, and to understand how they interact in the body.

Key facts

Study ID: NCT07431294
Run by: Bayer
People needed: 36
Starts: 2026-10-01
Expected to finish: 2027-05-07
Last updated by the study team: 2026-07-29

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant must be 40 to 80 years of age inclusive at the time of signing the informed consent
Participants with stable CAD defined by coronary artery stenosis in any of the 3 main coronary vessels greater than 50 percent documented by coronary angiography within the last 36 months or history of myocardial infarction more than 6 months prior to the screening visit
Estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL per min per 1.73 m2 at screening
Body weight greater than or equal to 60 kg and body mass index within the range greater than or equal to 18 and less than or equal to 36 kg per m2 at screening.

You may not qualify if…

Ejection fraction less than 30 percent at screening as determined by echocardiography
Progressive angina with symptoms of worsening of angina in the 3 months prior to the first screening examination and/or interventions such as revascularization by percutaneous coronary intervention and or coronary artery bypass graft during the last 3 months
Documented current relevant coronary stenosis greater than or equal to 90 percent in any of the main 3 coronary vessels without bypass graft
Significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis any other moderate or severe valvular failures hypertrophic obstructive cardiomyopathy
Symptomatic carotid stenosis or transient ischemic attack or stroke within 3 months prior to the first screening examination or patients with stroke at more than 3 months prior to the first screening examination with significant residual neurologic involvement
Atrial fibrillation pacemaker defibrillator atrial ventricular block II and III
History of sustained ventricular tachycardia or ventricular fibrillation within 12 months prior first screening visit
History of CNS diseases such as seizures neurodegenerative diseases
Lung diseases such as COPD GOLD stage 2-4 pulmonary arterial hypertension or asthma
Medical disorder condition or history of such that would impair the participant's ability to participate or complete the study in the opinion of the investigator.

Where it is running

Comac Medical | Phase I Clinical Research Unit — Sofia, Sofia City Province, Bulgaria
Universitätsklinikum Heidelberg - Zentrum für Innere Medizin, Abteilung Klinische Pharmakologie und Pharmakoepidemologie — Heidelberg, Baden-Wurttemberg, Germany
UK Bonn Institut für Klinische Chemie und Klinische Pharmakologie, Phase I Einheit und Arzneimitteltherapiesicherheit — Bonn, North Rhine-Westphalia, Germany
SocraTec R&D Erfurt-Clinical Pharmacology Unit — Erfurt, Thuringia, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.