Recent Updates
Recently added Catalysts

NNC0537-1482

Phase 1

Healthy Volunteers | Small molecule | Cardiovascular |Novo Nordisk A/S|Last Updated: Sep 1, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

NNC0537-1482 · 2 trials · 2 indications

Phase 1 2
NCT07218627A Research Study on the Effects of NNC0537-1482 in Participants With Heart FailureHeart Failure
RECRUITING36 Analytics
NCT06625307A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the SkinHealthy Volunteers
COMPLETED31 Analytics
PHASE1RECRUITING
A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure
Heart FailureUnlock trial analytics
PHASE1COMPLETED
A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the Skin
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treatment emergent adverse events (TEAE)
From pre-dose on day 1 until completion of the end of study (day 64)

Measured as number of events.

Number of treatment emergent adverse events (TEAE) in cohorts 1 and 2
From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 15

Number of events.

Number of treatment emergent adverse events (TEAE) in cohort 3
From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 22

Number of events.

Number of treatment emergent adverse events (TEAE) in cohorts 4, 5 and 6
From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 40

Number of events.

Secondary Endpoints

Cmax,MD; the maximum plasma concentration of NNC0537-1482 after last dose
From pre-dose on day 22 until completion of the end of study (day 64)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1AEXPERIMENTALParticipants will be administered once weekly dose level 1 of NNC0537-1482 subcutaneously.
Cohort 2AEXPERIMENTALParticipants will be administered once weekly dose level 2 of NNC0537-1482 subcutaneously.
Cohort 3AEXPERIMENTALParticipants will be administered once weekly dose level 3 of NNC0537-1482 subcutaneously.
Cohort 4AEXPERIMENTALParticipants will be administered once weekly dose level 4 of NNC0537-1482 subcutaneously.
Cohort 5AEXPERIMENTALParticipants will be administered once weekly dose level 5 of NNC0537-1482 subcutaneously.
Cohort BEXPERIMENTALParticipants will be administered a selected safe and tolerable dose level of NNC0537-1482 subcutaneously.
PlaceboPLACEBO_COMPARATORParticipants will be administered Placebo matched to NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 1EXPERIMENTALParticipants will be administered a single dose of dose level 1 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 2EXPERIMENTALParticipants will be administered a single dose of dose level 2 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 3EXPERIMENTALParticipants will be administered a single dose of dose level 3 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 4EXPERIMENTALParticipants will be administered a single dose of dose level 4 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 5EXPERIMENTALParticipants will be administered a single dose of dose level 5 of NNC0537-1482 subcutaneously.
NNC0537-1482 Dose level 6EXPERIMENTALParticipants will be administered a single dose of dose level 6 of NNC0537-1482 subcutaneously.

Interventions

NameTypeDescription
NNC0537-1482DRUGNNC0537-1482 will be administered subcutaneously.
PlaceboDRUGPlacebo will be administered subcutaneously.
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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...

Countries:United KingdomNetherlands
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT07218627Completion: 2027-01-15 → 2027-04-06
LOWSep 1, 2026NCT07218627Completion: 2027-01-15 → 2027-04-06
LOWAug 19, 2026NCT07218627lastUpdatePostDate: changed
LOWAug 19, 2026NCT07218627lastUpdatePostDate: changed
LOWAug 19, 2026NCT07218627lastUpdatePostDate: changed
MEDIUMJul 23, 2026NCT06625307TRIAL_REMOVED: changed
MEDIUMJul 23, 2026NCT06625307TRIAL_REMOVED: changed
MEDIUMJul 23, 2026NCT06625307TRIAL_REMOVED: changed

Frequently asked questions about NNC0537-1482

What is NNC0537-1482 used for?

NNC0537-1482 is an investigational small molecule being developed by Novo Nordisk A/S for the treatment of heart failure. It is currently in Phase 1 clinical development, with studies evaluating its effects in healthy volunteers and in participants with heart failure.

Who makes NNC0537-1482?

NNC0537-1482 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The drug is currently in Phase 1 clinical trials.

What phase is NNC0537-1482 in?

NNC0537-1482 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and effects in healthy volunteers and in participants with heart failure.

What clinical trials is NNC0537-1482 in?

NNC0537-1482 is being studied in two Phase 1 trials. NCT06625307, a completed study in healthy volunteers in the Netherlands, and NCT07218627, a recruiting study in participants with heart failure in the United Kingdom. Both trials are randomized, double-blind, and placebo-controlled.

How is NNC0537-1482 administered?

NNC0537-1482 is administered by injection under the skin. This route of administration is being evaluated in clinical trials, including a completed study in healthy volunteers and an ongoing study in participants with heart failure.