Healthy VolunteersPhase 1NCT06625307
A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the Skin
A Phase 1 study testing NNC0537-1482 in people with Healthy Volunteers and Heart Failure, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial summary
The study is testing a new medicine to potentially treat people with heart failure. The main purpose of the study is to see if the new study medicine is safe and how it works in the body. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, 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
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Oct 2024to 4 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or postmenopausal female.
- Age 22-55 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) between 18.5 and 30.0 kilogram/meter per square (kg/m^2) (both inclusive) at screening.
- Considered eligible and generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Use of prescription or non-prescription medicinal products, including herbal medications, within 14 days before screening. Occasional use of over-the-counter vitamins, or paracetamol or Non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain is permitted.
- Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than or equal to 20 millimetres of mercury (mmHg) or a decrease in diastolic blood pressure greater than or equal to 10 (mmHg) from supine to standing after 3 minutes, at the screening visit.
- Any laboratory safety parameters at screening outside the below laboratory ranges for:
- Alanine Aminotransferase (ALT) greater than (>) Upper normal limits (UNL) plus (+) 10 Percentage (%)
Show all 9Show fewer
- Aspartate Aminotransferase (AST) > Upper limit normal (ULN) +20%
- Bilirubin > ULN + 20%
- Creatinine > ULN + 10%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human Randomised, Placebo-controlled and Double-blinded Single Ascending Dose Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administrations of NNC0537-1482 in Healthy Participants.
The study is testing a new medicine to potentially treat people with heart failure. The main purpose of the study is to see if the new study medicine is safe and how it works in the body. It is the first time NNC0537-1482 (the new study medicine) is tested in humans and will be tested in healthy individuals (men and postmenopausal women). Participant will either get NNC0537-1482 or placebo (a "dummy medicine" without any active ingredients). Which treatment the participant get is decided by chance and the participant will only get either the study medicine or placebo on one occasion. It will be injected under the skin of the stomach by the study staff and the number of injections will depend on the cohort participant is assigned to. NNC0537-1482 cannot be prescribed by doctors. The study consists of 6 cohorts (groups) with 6 different dosing levels. The study will last for about 9 months. Participation in the study will last up to 42 days (depending on the cohort participant are assigned to) with an additional screening period that can be up to 28 days. Participant will have up to 10 visits to the clinic during the study period. However, the total number of visits depend on which cohort participant is assigned to.
- Conditions
- Healthy Volunteers, 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
Administered via subcutaneous route
PlaceboDrug
Administered via subcutaneous route
| Study group | Role | What they receive |
|---|---|---|
| NNC0537-1482 Dose level 1 | Experimental | Participants will be administered a single dose of dose level 1 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482; Drug: Placebo |
| NNC0537-1482 Dose level 2 | Experimental | Participants will be administered a single dose of dose level 2 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482; Drug: Placebo |
| NNC0537-1482 Dose level 3 | Experimental | Participants will be administered a single dose of dose level 3 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482; Drug: Placebo |
| NNC0537-1482 Dose level 4 | Experimental | Participants will be administered a single dose of dose level 4 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482; Drug: Placebo |
| NNC0537-1482 Dose level 5 | Experimental | Participants will be administered a single dose of dose level 5 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482; Drug: Placebo |
| NNC0537-1482 Dose level 6 | Experimental | Participants will be administered a single dose of dose level 6 of NNC0537-1482 subcutaneously. Receives: Drug: NNC0537-1482; Drug: Placebo |
| Placebo | Placebo comparator | Participants will be administered a single dose of 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) in cohorts 1 and 2
Number of events.
Measured: From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 15
Number of treatment emergent adverse events (TEAE) in cohort 3
Number of events.
Measured: From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 22
Number of treatment emergent adverse events (TEAE) in cohorts 4, 5 and 6
Number of events.
Measured: From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start3 Oct 2024
- Primary completion4 May 2025
- Study completion4 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 31 participants (actual)
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
- NCT06625307
- Sponsor's protocol ID
- NN6537-7650
- Other IDs
- U1111-1298-6922, 2024-514431-18
- Status last verified
- Jun 2026
- First submitted
- 2 Oct 2024
- Last updated
- 22 Jun 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Randomised, Placebo-controlled and Double-blinded Single Ascending Dose Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administrations of NNC0537-1482 in Healthy Participants.
- ClinicalTrials.gov ID
- NCT06625307
- Acronym / sponsor ID
- NN6537-7650
- Conditions
- Healthy Volunteers, Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 4 May 2025 (actual)
- Study completion
- 4 May 2025 (actual)
- First posted
- 3 Oct 2024 (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 medicine to potentially treat people with heart failure. The main purpose of the study is to see if the new study medicine is safe and how it works in the body. It is the first time NNC0537-1482 (the new study medicine) is tested in humans and will be tested in healthy individuals (men and postmenopausal women). Participant will either get NNC0537-1482 or placebo (a "dummy medicine" without any active ingredients). Which treatment the participant get is decided by chance and the participant will only get either the study medicine or placebo on one occasion. It will be injected under the skin of the stomach by the study staff and the number of injections will depend on the cohort participant is assigned to. NNC0537-1482 cannot be prescribed by doctors. The study consists of 6 cohorts (groups) with 6 different dosing levels. The study will last for about 9 months. Participation in the study will last up to 42 days (depending on the cohort participant are assigned to) with an additional screening period that can be up to 28 days. Participant will have up to 10 visits to the clinic during the study period. However, the total number of visits depend on which cohort participant is assigned to.
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 |
|---|---|---|
| NNC0537-1482 Dose level 1 | Experimental | Drug: NNC0537-1482, Drug: PlaceboParticipants will be administered a single dose of dose level 1 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 2 | Experimental | Drug: NNC0537-1482, Drug: PlaceboParticipants will be administered a single dose of dose level 2 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 3 | Experimental | Drug: NNC0537-1482, Drug: PlaceboParticipants will be administered a single dose of dose level 3 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 4 | Experimental | Drug: NNC0537-1482, Drug: PlaceboParticipants will be administered a single dose of dose level 4 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 5 | Experimental | Drug: NNC0537-1482, Drug: PlaceboParticipants will be administered a single dose of dose level 5 of NNC0537-1482 subcutaneously. |
| NNC0537-1482 Dose level 6 | Experimental | Drug: NNC0537-1482, Drug: PlaceboParticipants will be administered a single dose of dose level 6 of NNC0537-1482 subcutaneously. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered a single dose of Placebo matched to NNC0537-1482 subcutaneously |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or postmenopausal female.
- Age 22-55 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) between 18.5 and 30.0 kilogram/meter per square (kg/m^2) (both inclusive) at screening.
- Considered eligible and generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (9 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Use of prescription or non-prescription medicinal products, including herbal medications, within 14 days before screening. Occasional use of over-the-counter vitamins, or paracetamol or Non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain is permitted.
- Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than or equal to 20 millimetres of mercury (mmHg) or a decrease in diastolic blood pressure greater than or equal to 10 (mmHg) from supine to standing after 3 minutes, at the screening visit.
- Any laboratory safety parameters at screening outside the below laboratory ranges for:
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 |
|---|---|---|
| NNC0537-1482Administered via subcutaneous route | Drug | NNC0537-1482 Dose level 1, NNC0537-1482 Dose level 2, NNC0537-1482 Dose level 3, NNC0537-1482 Dose level 4, NNC0537-1482 Dose level 5, NNC0537-1482 Dose level 6 |
| PlaceboAdministered via subcutaneous route | Drug | NNC0537-1482 Dose level 1, NNC0537-1482 Dose level 2, NNC0537-1482 Dose level 3, NNC0537-1482 Dose level 4, NNC0537-1482 Dose level 5, NNC0537-1482 Dose level 6, Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAE) in cohorts 1 and 2
Time frame: 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
Time frame: 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
Time frame: From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 40
Number of events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Screening Protocol
Pain
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. This study is not recruiting at the moment.
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 Healthy Volunteers and Heart Failure, run by Novo Nordisk A/S at 1 site in Netherlands.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 22 Jun 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment emergent adverse events (TEAE) in cohorts 1 and 2 (time frame: From pre-dose on Day 1 until completion of the End of study visit (V10) at Day 15). The study lists 3 primary outcomes in all. 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 22 Jun 2026.