Healthy VolunteersPhase 1NCT05599945

First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

A Phase 1 study testing NNC0581-0001 in people with Healthy Volunteers and Hepatic Steatosis, run by Novo Nordisk A/S at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). 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, Hepatic Steatosis
What is being tested?: NNC0581-0001
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 2 sitesUnited Kingdom
Study dates: 23 Nov 2022to 29 Aug 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 18.5 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.
Inclusion criteria for participants with hepatic steatosis in Part B:
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 25.0 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
Hepatic steatosis identified by a score above 248 dB/m by Fibroscan® (Controlled Attenuated Parameter, CAP) at screening.

Who cannot join

Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
For Part A: Any laboratory safety parameters at screening outside the below laboratory ranges, 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) greater than upper normal limit (UNL) plus 10 percent
Aspartate aminotransferase (AST) greater than UNL plus 10 percent
Bilirubin greater than UNL plus 10 percent
Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m^2)
Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole [mmol/mol]) at screening.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Parexel CPRU, Level 7
Harrow, Middlesex, HA1 3UJ
Parexel Research Unit
Harrow, Middlesex, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis

Conditions: Healthy Volunteers, Hepatic Steatosis
Being tested: NNC0581-0001, Placebo (NNC0581-0001)
Medical subject headings: Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NNC0581-0001Drug
Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.
Placebo (NNC0581-0001)Drug
Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Study groups in NCT05599945
Study group	Role	What they receive
Single Dose 1: NNC0581-0001 10 milligram (mg)	Experimental	Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)
Single Dose 2: NNC0581-0001 30 mg	Experimental	Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)
Single Dose 3: NNC0581-0001 90 mg	Experimental	Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)
Single Dose 4: NNC0581-0001 250 mg	Experimental	Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)
Single Dose 5: NNC0581-001 600 mg	Experimental	Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)
Single Dose 6: NNC0581-001 1000 mg	Experimental	Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 1000 mg or matching placebo injection subcutaneously. Receives: Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001)

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 completion of the End of Study Visit at week 52

Secondary outcomes (3)

AUC0-∞: The area under the NNC0581-0001 plasma concentration-time curve from time zero to infinity after a single dose
Measured in nanogram hour per mililiter (ng*h/mL).
Measured: From dosing (Day 1) to 168 hours after dosing
Cmax: The maximum concentration of NNC0581-0001 in plasma after a single dose
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 NNC0581-0001 after a single dose
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.

23 Nov 202229 Aug 2025

First posted31 Oct 2022
Study start23 Nov 2022
Primary completion29 Aug 2025
Study completion29 Aug 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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05599945
Sponsor's protocol ID: NN6581-4860
Other IDs: U1111-1274-4577, 2022-001359-18
Status last verified: Oct 2025
First submitted: 26 Oct 2022
Last updated: 9 Oct 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis
ClinicalTrials.gov ID: NCT05599945
Acronym / sponsor ID: NN6581-4860
Conditions: Healthy Volunteers, Hepatic Steatosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 23 Nov 2022 (actual)
Primary completion: 29 Aug 2025 (actual)
Study completion: 29 Aug 2025 (actual)
First posted: 31 Oct 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.

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: NNC0581-0001 10 milligram (mg)	Experimental	Drug: NNC0581-0001, Drug: Placebo (NNC0581-0001)Part A: Healthy participants will receive a single dose of NNC0581-0001 10 mg or matching placebo injection subcutaneously.
Single Dose 2: NNC0581-0001 30 mg	Experimental	Drug: NNC0581-0001, Drug: Placebo (NNC0581-0001)Part A: Healthy participants will receive a single dose of NNC0581-0001 30 mg or matching placebo injection subcutaneously.
Single Dose 3: NNC0581-0001 90 mg	Experimental	Drug: NNC0581-0001, Drug: Placebo (NNC0581-0001)Part A: Healthy participants will receive a single dose of NNC0581-0001 90 mg or matching placebo injection subcutaneously.
Single Dose 4: NNC0581-0001 250 mg	Experimental	Drug: NNC0581-0001, Drug: Placebo (NNC0581-0001)Part A: Healthy participants will receive a single dose of NNC0581-0001 250 mg or matching placebo injection subcutaneously.
Single Dose 5: NNC0581-001 600 mg	Experimental	Drug: NNC0581-0001, Drug: Placebo (NNC0581-0001)Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 600 mg or matching placebo injection subcutaneously.
Single Dose 6: NNC0581-001 1000 mg	Experimental	Drug: NNC0581-0001, Drug: Placebo (NNC0581-0001)Part B: Participants with hepatic steatosis will receive a single dose of NNC0581-0001 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 (7 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 18.5 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.
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 25.0 to 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.

Key exclusion criteria (7 listed)

Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
For Part A: Any laboratory safety parameters at screening outside the below laboratory ranges, 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) greater than upper normal limit (UNL) plus 10 percent
Aspartate aminotransferase (AST) greater than UNL plus 10 percent
Bilirubin greater than UNL plus 10 percent

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
NNC0581-0001Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.	Drug	Single Dose 1: NNC0581-0001 10 milligram (mg), Single Dose 2: NNC0581-0001 30 mg, Single Dose 3: NNC0581-0001 90 mg, Single Dose 4: NNC0581-0001 250 mg, Single Dose 5: NNC0581-001 600 mg, Single Dose 6: NNC0581-001 1000 mg
Placebo (NNC0581-0001)Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.	Drug	Single Dose 1: NNC0581-0001 10 milligram (mg), Single Dose 2: NNC0581-0001 30 mg, Single Dose 3: NNC0581-0001 90 mg, Single Dose 4: NNC0581-0001 250 mg, Single Dose 5: NNC0581-001 600 mg, Single Dose 6: NNC0581-001 1000 mg

Primary outcome

Number of treatment emergent adverse events (TEAEs)
Time frame: From dosing (Day 1) until completion of the End of Study Visit at week 52
Measured as number of events.

3 secondary outcomes

AUC0-∞: The area under the NNC0581-0001 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 NNC0581-0001 in plasma after a single dose
Time frame: From dosing (Day 1) to 168 hours after dosing
tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after a single dose
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 9 Oct 2025.
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. This study is not recruiting at the moment.

Clinical Transparency dept. 2834 study director

Novo Nordisk A/S

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0581-0001 in people with Healthy Volunteers and Hepatic Steatosis, run by Novo Nordisk A/S at 2 sites 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 7 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 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 completion of the End of Study Visit at week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599945.

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 9 Oct 2025.