Heart FailurePhase 1NCT07218627
A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure
A Phase 1 study testing NNC0537-1482 in people with Heart Failure, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- NNC0537-1482
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2025to 6 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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/m^2).
- Symptomatic heart failure (New York Heart Association class II-III).
- Stable standard of care medical therapy for heart failure with mildly reduced ejection fraction/heart failure with preserved ejection fraction (HFmrEF/HFpEF) defined by:
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- No addition or removal of sodium-glucose cotransporter 2 inhibitors (SGLT2i), angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers (BBs,) calcium-channel blockers or aldosterone antagonists, and no substantial change in dosage (greater than or equal to (≥)100% increase/decrease) at least 4 weeks before screening.
- On a diuretic therapy at least 2 weeks before screening without substantial change in dosing (≥50% increase/decrease), and on a stable diuretic therapy at least 1 week before screening.
- On the stable doses (not in titration period) of standard medical therapy for other comorbidities
- No hospitalizations due to heart failure (HF) between screening (V1) and randomisation (V2) confirmed at randomisation.
- Left ventricle ejection fraction (LVEF) greater than (>) 40 percentage (%) documented by echocardiography at screening, or within 12 months prior to screening with no change in clinical status suggesting potential for deterioration in systolic function.
- AND at least one of the following:
- N-terminal pro type-B natriuretic peptide (NT-proBNP) ≥125 picogram per milliliter (pg/mL) (for participants with sinus rhythm) or NT-proBNP ≥375 pg/mL (for participants with persistent/permanent atrial fibrillation) at screening, and ≥1 of the following (documented by echocardiography within 12 months prior to or at screening):
- Septal é <7 or lateral <10 or average E/é ≥10
- Pulmonary artery (PA) systolic pressure >35 millimeters of mercury (mmHg)
- Left atrium (LA) enlargement, (width ≥3.8 centimeter (cm) or length ≥5.0 cm or area ≥20.0 square centimeter (cm^2) or volume ≥55 milliliter (mL) or left atrial volume index (LAVI) ≥29 milliliter per square meter (mL/m^2)
- Left ventricular hypertrophy (LVH) with septal thickness or posterior wall thickness ≥1.2 cm.
- Hospitalization with a primary diagnosis of decompensated HF requiring intravenous loop diuretic treatment within previous 12 months, and ≥2 of the following (documented by echocardiography within 12 months prior to or at screening):
- Septal é <7 or lateral <10 or average E/é ≥10
- PA systolic pressure >35 mmHg
- LA enlargement, (width ≥3.8 cm or length ≥5.0 cm or area ≥20.0 cm^2 or volume ≥55 mL or LAVI ≥29 mL/m^2)
- LVH with septal thickness or posterior wall thickness ≥1.2 cm
- Ongoing use of diuretic therapy for ≥30 days before screening.
- Mean pulmonary capillary wedge pressure (PWP) ≥15 mmHg or left ventricular end-diastolic pressure (LVEDP) ≥15 mmHg documented during catheterization at rest or PA diastolic pressure measured by implantable monitor ≥15 mmHg or PWP or LVEDP ≥25 mmHg documented during catheterization at exercise.
Who cannot join
- 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.
- Current acute decompensated HF requiring augmented therapy.
- Hospitalisation within the last 90 days prior to screening with HF as the primary cause.
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- Known or suspected hypersensitivity to study intervention(s) or related products.
- Probable alternative diagnoses that in the opinion of the investigator could account for the participant's HF symptoms (i.e., dyspnoea, fatigue) such as significant pulmonary disease (including primary pulmonary hypertension, severe chronic obstructive pulmonary disease), anaemia, hypothyroidism or obesity.
- Systolic blood pressure outside the range of 110-160 mmHg at screening or randomisation.
- Heart rate outside the range of 40-110 beats per minute (bpm) at screening or randomisation.
- Orthostatic hypotension (defined as a decrease in systolic blood pressure ≥20 mmHg or a decrease in diastolic blood pressure ≥10 mmHg from a supine position to standing after 3 minutes, at screening or randomisation).
- Atrioventricular-block II or III, QRS >120 milliseconds (ms), or QTcF interval >450 ms for men and >470 ms for women, or any other clinically significant abnormal electrocardiogram (ECG) results as judged by the investigator at screening or randomisation.
- Participant has pacemaker, or implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT) or left ventricular assist device (LVAD).
- Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 bpm at screening or at randomisation.
- Significant changes of prescription medicinal products (dose or frequency) or non-prescription drugs between screening and randomisation visits, per investigator's assessment.
- Blood donation, plasma donation or blood draw any of the circumstances below:
- 400 mL within the past 90 days prior to the day of screening
- 50 mL within the past 30 days prior to the day of screening.
- Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the 3 months after screening.
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2 times upper limit of normal (ULN).
- Estimated glomerular filtration (eGFR) <20 milliliter per minute per 1.73 square meter according to 2021 CKD-EPI equation.
- History or presence of any other disease (i.e., including malignancies) with a life expectancy of <1 year at screening.
- Receiving insulin for the treatment of diabetes type 1 or diabetes type 2.
- Glycated haemoglobin (HbA1c) of > 8.0% as measured at screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Richmond Pharmacology
London, SE1 1YR
About this study
Official 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
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.
- Conditions
- Heart Failure
- Being tested
- NNC0537-1482, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0537-1482Drug
NNC0537-1482 will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | Participants will be administered once weekly dose level 1 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482 |
| Cohort 2A | Experimental | Participants will be administered once weekly dose level 2 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482 |
| Cohort 3A | Experimental | Participants will be administered once weekly dose level 3 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482 |
| Cohort 4A | Experimental | Participants will be administered once weekly dose level 4 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482 |
| Cohort 5A | Experimental | Participants will be administered once weekly dose level 5 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482 |
| Cohort B | Experimental | Participants will be administered a selected safe and tolerable dose level of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482 |
| Placebo | Placebo comparator | Participants will be administered Placebo matched to NNC0537-1482 subcutaneously. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAE)
Measured as number of events.
Measured: From pre-dose on day 1 until completion of the end of study (day 64)
Secondary outcomes (1)
Cmax,MD; the maximum plasma concentration of NNC0537-1482 after last dose
Measured in nanomoles per liter (nmol/L).
Measured: From pre-dose on day 22 until completion of the end of study (day 64)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start23 Oct 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion6 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218627
- Sponsor's protocol ID
- NN6537-7866
- Other IDs
- U1111-1313-9985
- Status last verified
- Aug 2026
- First submitted
- 16 Oct 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07218627
- Acronym / sponsor ID
- NN6537-7866
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 6 Apr 2027 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Drug: NNC0537-1482Participants will be administered once weekly dose level 1 of NNC0537-1482 subcutaneously. |
| Cohort 2A | Experimental | Drug: NNC0537-1482Participants will be administered once weekly dose level 2 of NNC0537-1482 subcutaneously. |
| Cohort 3A | Experimental | Drug: NNC0537-1482Participants will be administered once weekly dose level 3 of NNC0537-1482 subcutaneously. |
| Cohort 4A | Experimental | Drug: NNC0537-1482Participants will be administered once weekly dose level 4 of NNC0537-1482 subcutaneously. |
| Cohort 5A | Experimental | Drug: NNC0537-1482Participants will be administered once weekly dose level 5 of NNC0537-1482 subcutaneously. |
| Cohort B | Experimental | Drug: NNC0537-1482Participants will be administered a selected safe and tolerable dose level of NNC0537-1482 subcutaneously. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered Placebo matched to NNC0537-1482 subcutaneously. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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/m^2).
- Symptomatic heart failure (New York Heart Association class II-III).
Key exclusion criteria (24 listed)
- 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.
- Current acute decompensated HF requiring augmented therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0537-1482NNC0537-1482 will be administered subcutaneously. | Drug | Cohort 1A, Cohort 2A, Cohort 3A, Cohort 4A, Cohort 5A, Cohort B |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAE)
Time frame: From pre-dose on day 1 until completion of the end of study (day 64)
Measured as number of events.
1 secondary outcome
Cmax,MD; the maximum plasma concentration of NNC0537-1482 after last dose
Time frame: From pre-dose on day 22 until completion of the end of study (day 64)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0537-1482 in people with Heart Failure, run by Novo Nordisk A/S at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (TEAE) (time frame: From pre-dose on day 1 until completion of the end of study (day 64)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.