A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-75
SponsorNovo Nordisk A/S
About this trial
The study is testing a new drug (NNC0537-1482) to potentially treat people with heart failure. The purpose of the study is to see if NNC0537-1482 is safe and how it works in the body. Participants will either get NNC0537-1482 or placebo (a "dummy drug" without any active ingredients) and which treatment they get is decided by chance. This study will last up to 64 days with an additional screening period up to 28 days.
Eligibility criteria
Qualifiers
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Male or females of non-childbearing potential.
Age 40-75 years (both inclusive) at the time of signing the informed consent.
Body Mass Index (BMI) range 18.5 - less than (<) 40 kilograms per square meter (kg/m²).
Disqualifiers
Any prior echo measurement of LVEF less than or equal to (≤) 40%, under stable conditions, within the past 36 months.
Previous participation in this study (defined as being randomised).
Ongoing treatment with a neprilysin inhibitor (including angiotensin receptor/neprilysin inhibitor treatment), phosphodiesterase-5 (PDE5) inhibitors or soluble guanylate cyclase (sGC) stimulators.
Acute coronary syndrome (ACS) (including myocardial infarction (MI)), stroke, transient ischemic attack (TIA), carotid surgery or angioplasty, cardiac surgery, other major cardiovascular surgery, or urgent percutaneous coronary intervention within the 3 months prior to screening.
Trial design
Treatments tested in this trial
- NNC0537-1482
- Placebo
Treatment groups
36 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov