Healthy VolunteersPhase 1NCT05624580
A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy Adults
A Phase 1 study testing NNC0582-0001 in people with Healthy Volunteers, run by Novo Nordisk A/S at 1 site in Austria.
Trial summary
This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NNC0582-0001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteAustria
- Study dates
- 15 Nov 2022to 16 Oct 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- Considered to be 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
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole [mmol/mol]) at screening.
- Any of the below laboratory safety parameters at screening outside normal range, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase (AST)
- Bilirubin
- Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73m^2 (mL/min/1.73m^2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injections of NNC0582-0001 in Healthy Adults
This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.
- Conditions
- Healthy Volunteers
- Being tested
- NNC0582-0001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0582-0001Drug
Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts.
PlaceboDrug
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose 1: NNC0582-0001 10 milligram (mg) | Experimental | Participants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0582-0001; Drug: Placebo |
| Single Dose 2: NNC0582-0001 30 mg | Experimental | Participants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0582-0001; Drug: Placebo |
| Single Dose 3: NNC0582-0001 90 mg | Experimental | Participants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0582-0001; Drug: Placebo |
| Single Dose 4: NNC0582-0001 250 mg | Experimental | Participants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0582-0001; Drug: Placebo |
| Single Dose 5: NNC0582-0001 600 mg | Experimental | Participants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0582-0001; Drug: Placebo |
| Single Dose 6: NNC0582-0001 1000 mg | Experimental | Participants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0582-0001; 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 (TEAEs)
Measured as number of events.
Measured: From dosing (Day 1) until End of Study visit (Week 52)
Secondary outcomes (3)
AUC0-∞: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose.
Measured in hours * nanogram per mililiter (h*ng/mL).
Measured: From dosing (Day 1) to 168 hours after dosing
Cmax: The maximum concentration of NNC0582-0001 in plasma
Measured in nanogram per mililiter (ng/mL).
Measured: From dosing (Day 1) to 168 hours after dosing
tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001
Measured in hours.
Measured: From dosing (Day 1) to 168 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start15 Nov 2022
- Primary completion16 Oct 2025
- Study completion16 Oct 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
- 56 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
- NCT05624580
- Sponsor's protocol ID
- NN6582-4838
- Other IDs
- U1111-1274-4316, 2022-001813-38, 2023-506928-83, 2023
- Status last verified
- Dec 2025
- First submitted
- 8 Nov 2022
- Last updated
- 24 Dec 2025
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injections of NNC0582-0001 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05624580
- Acronym / sponsor ID
- NN6582-4838
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 22 Nov 2022 (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.
This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single Dose 1: NNC0582-0001 10 milligram (mg) | Experimental | Drug: NNC0582-0001, Drug: PlaceboParticipants will receive a single dose of NNC0582-0001 10 mg or matching placebo injection subcutaneously. |
| Single Dose 2: NNC0582-0001 30 mg | Experimental | Drug: NNC0582-0001, Drug: PlaceboParticipants will receive a single dose of NNC0582-0001 30 mg or matching placebo injection subcutaneously. |
| Single Dose 3: NNC0582-0001 90 mg | Experimental | Drug: NNC0582-0001, Drug: PlaceboParticipants will receive a single dose of NNC0582-0001 90 mg or matching placebo injection subcutaneously. |
| Single Dose 4: NNC0582-0001 250 mg | Experimental | Drug: NNC0582-0001, Drug: PlaceboParticipants will receive a single dose of NNC0582-0001 250 mg or matching placebo injection subcutaneously. |
| Single Dose 5: NNC0582-0001 600 mg | Experimental | Drug: NNC0582-0001, Drug: PlaceboParticipants will receive a single dose of NNC0582-0001 600 mg or matching placebo injection subcutaneously. |
| Single Dose 6: NNC0582-0001 1000 mg | Experimental | Drug: NNC0582-0001, Drug: PlaceboParticipants will receive a single dose of NNC0582-0001 1000 mg or matching placebo injection subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- Considered to be 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 (7 listed)
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole [mmol/mol]) at screening.
- Any of the below laboratory safety parameters at screening outside normal range, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase (AST)
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 |
|---|---|---|
| NNC0582-0001Participants will receive single dose of any of the six dose levels of subcutaneous NNC0582-0001 in a sequential manner with the dose increasing between cohorts. | Drug | Single Dose 1: NNC0582-0001 10 milligram (mg), Single Dose 2: NNC0582-0001 30 mg, Single Dose 3: NNC0582-0001 90 mg, Single Dose 4: NNC0582-0001 250 mg, Single Dose 5: NNC0582-0001 600 mg, Single Dose 6: NNC0582-0001 1000 mg |
| PlaceboParticipants will receive single dose of subcutaneous injection of placebo matched to NNC0582-0001. | Drug | Single Dose 1: NNC0582-0001 10 milligram (mg), Single Dose 2: NNC0582-0001 30 mg, Single Dose 3: NNC0582-0001 90 mg, Single Dose 4: NNC0582-0001 250 mg, Single Dose 5: NNC0582-0001 600 mg, Single Dose 6: NNC0582-0001 1000 mg |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From dosing (Day 1) until End of Study visit (Week 52)
Measured as number of events.
3 secondary outcomes
AUC0-∞: The area under the NNC0582-0001 plasma concentration-time curve from time zero to infinity after a single dose.
Time frame: From dosing (Day 1) to 168 hours after dosing
Cmax: The maximum concentration of NNC0582-0001 in plasma
Time frame: From dosing (Day 1) to 168 hours after dosing
tmax: The time from dose administration to maximum plasma concentration of NNC0582-0001
Time frame: From dosing (Day 1) to 168 hours after dosing
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 24 Dec 2025.
- 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 NNC0582-0001 in people with Healthy Volunteers, run by Novo Nordisk A/S at 1 site in Austria.
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 3 inclusion and 7 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 24 Dec 2025. 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 Austria. 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. 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 (TEAEs) (time frame: From dosing (Day 1) until End of Study visit (Week 52)). 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 24 Dec 2025.