RecruitingPhase 1NCT07218627

A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure

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


Sponsor

Novo Nordisk A/S

Enrollment

36 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called NNC0537-1482 in people with heart failure with a preserved or mildly reduced pumping function (known as HFmrEF or HFpEF). In this type of heart failure, the heart pumps adequately but is too stiff, leading to symptoms like shortness of breath and fatigue. **You may be eligible if...** - You are between 40 and 75 years old (both inclusive) - You have been diagnosed with heart failure with symptoms (NYHA Class II or III — moderate symptoms) - Your heart failure medications have been stable for at least 4 weeks before the study - You are a male or a female who is not of childbearing potential - Your BMI is between 18.5 and less than 40 **You may NOT be eligible if...** - You have recently changed your heart failure medications - You are pregnant or of childbearing potential - You have severe kidney or liver problems - You have certain other serious heart conditions not consistent with HFmrEF/HFpEF Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNNC0537-1482

NNC0537-1482 will be administered subcutaneously.

DRUGPlacebo

Placebo will be administered subcutaneously.


Locations(1)

Richmond Pharmacology

London, United Kingdom

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NCT07218627


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