A research study on the effects of NNC0537-1482 in participants with heart failure
Research type
Research Study
Full title
A randomised, placebo-controlled, double-blinded phase 1b study investigating safety, tolerability, pharmacokinetics and effects on biomarkers from multiple ascending doses of NNC0537-1482 in participants with heart failure
IRAS ID
1012056
Contact name
Angela Coggi
Contact email
Sponsor organisation
Novo Nordisk A/S
Research summary
Novo Nordisk is founding this research to evaluate the ability of a new drug NNC0537-1482, to treat participants with heart failure.
Heart Failure (HF) affects approximately 1.6% of the UK population. The risk of developing HF increases with age, and it leads to high rates of mortality and morbidity, as well as has major effects on physical abilities and quality of life. HF is a systemic, multi-organ syndrome caused by structural or functional abnormalities of the heart, leading to its inability to pump blood effectively. This results in a range of distressing symptoms, including shortness of breath, fatigue, and ankle swelling.
There are two main types of chronic HF: HFrEF (heart failure with reduced ejection fraction) and HFpEF (heart failure with preserved ejection fraction). HFpEF makes up about half of all HF cases, and its numbers have grown in recent years. Right now, the only recommended prognostic treatment for HFpEF is SGLT2 inhibitor (empagliflozin), which shows the major need in developing treatment options for this group of patients.
NNC0537-1482 is a peptide-based CNP-analogue developed as a subcutaneous injection. C-type natriuretic peptide (CNP) is a mediator that regulates the structure and function of blood vessels and heart muscle. Targeting CNP signalling pathways appears very attractive in patients with HFpEF.
The main aim of this study is to look at safety and tolerability of NNC0537-1482. In addition, this clinical trial will also look at how long the drug remains in body(pharmacokinetics), how it effects the body (pharmacodynamics), and it effects on biomarkers.
This study is a single-centre, randomised, placebo-controlled and double-blinded study. A total of 48 participants with HFpEF are planned to be included to 5 cohorts at ascending dose levels (MAD). The planned duration of the study for each participant is 14 weeks.
REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0257
Date of REC Opinion
2 Jul 2025
REC opinion
Further Information Unfavourable Opinion