Healthy VolunteersPhase 1NCT06891365
Multiple Dose Study 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 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- 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
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2025to 15 Nov 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Considered eligible 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.
- Male or female (of non-childbearing potential) aged 18-69 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) greater than or equal to (>=) 25.0 at screening.
- Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) >= 10 percent at screening.
- Additional inclusion criteria for participants in the open-label liver biopsy cohort apply:
- Alanine aminotransferase (ALT) in men greater than (>) 30 units per liter (U/L), women > 19 U/L
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- Liverstiffness, measured by FibroScan® (VCTE) > 8 kPa and less than (<) 12 kPa
- Informed consent obtained at screening for a liver biopsy to be performed at baseline and post-treatment.
- Note: Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH), based on a prior liver biopsy, can be included in the open-label cohort.
Who cannot join
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any laboratory safety parameter, at screening, outside the extended laboratory ranges, and considered clinically significant per the principal investigator (see laboratory provided reference ranges for specific values). Of note, re-screening or re-sampling is NOT allowed if the individual has failed one of the exclusion criteria related to the following laboratory parameters:
- ALT >= 3 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >= 3 × ULN
- Bilirubin > 1.5 × ULN
- Estimated glomerular filtration rate (eGFR) < 50 milliliter per minute per 1.73 square meters (mL/min/1.73 m^2) at screening.
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- Additional exclusion criteria for participants in the open-label liver biopsy group apply:
- Medical history of abnormal bleeding
- BMI > 34.9 kilograms per square meters (kg/m^2)
- Presence of ascites
- Cirrhosis based on screening tests or historical biopsy
- Lab abnormalities of platelets count < 150 × 10^9 per liter or International Normalized Ratio (INR) > 1.2
- Concomitant use of medication:
- anticoagulants or herbal supplements with an anticoagulative effect (as judged by the principal investigator)
- antiplatelet medications
- exception for aspirin that must be stopped 5 days prior to procedure and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that must not be taken within 3 days of the procedure.
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
Parexel Research Unit
Harrow, HA1 3UJ
About this study
Official title: Investigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of NNC0581-0001 in Participants With Hepatic Steatosis and Suspected Steatohepatitis
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance. NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.
- 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
NNC0581-0001 will be administered subcutaneously.
Placebo (NNC0581-0001)Drug
Placebo matched to NNC0581-0001 will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: NNC0581-0001 (Dose 1) | Experimental | Participants will receive a subcutaneous (s.c) injection of either NNC0581-0001 Dose 1 or a matching placebo once monthly. Receives: Drug: NNC0581-0001; Drug: Placebo (NNC0581-0001) |
| Cohort 2: NNC0581-0001 (Dose 2) | Experimental | Participants will receive a s.c injection of either NNC0581-0001 Dose 2 or a matching placebo once monthly. 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 count of events.
Measured: From 1st dose (day 1) until completion of the end of study visit at week 52
Secondary outcomes (3)
AUC0-32h: The area under the NNC0581-0001 plasma concentration-time curve from time zero to 32 hours after each of the three doses
Measured in nanogram hour per mililitre (ng*h/mL).
Measured: From dosing (day 1 in each treatment period) to 32 hours post dose
Cmax: The maximum concentration of NNC0581-0001 in plasma after each dose of three doses
Measured in nanogram per mililitre(ng/mL).
Measured: From dosing (day 1 in each treatment period) to 32 hours post dose
Tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after each dose of three doses
Measured in hours.
Measured: From dosing (day 1 in each treatment period) to 32 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start12 Mar 2025
- Primary completion11 Oct 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT06891365
- Sponsor's protocol ID
- NN6581-4981
- Other IDs
- U1111-1298-9628
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2025
- Last updated
- 7 Apr 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of NNC0581-0001 in Participants With Hepatic Steatosis and Suspected Steatohepatitis
- ClinicalTrials.gov ID
- NCT06891365
- Acronym / sponsor ID
- NN6581-4981
- Conditions
- Healthy Volunteers, Hepatic Steatosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 11 Oct 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 24 Mar 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 purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance. NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: NNC0581-0001 (Dose 1) | Experimental | Drug: NNC0581-0001, Drug: Placebo (NNC0581-0001)Participants will receive a subcutaneous (s.c) injection of either NNC0581-0001 Dose 1 or a matching placebo once monthly. |
| Cohort 2: NNC0581-0001 (Dose 2) | Experimental | Drug: NNC0581-0001, Drug: Placebo (NNC0581-0001)Participants will receive a s.c injection of either NNC0581-0001 Dose 2 or a matching placebo once monthly. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Considered eligible 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.
- Male or female (of non-childbearing potential) aged 18-69 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) greater than or equal to (>=) 25.0 at screening.
- Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) >= 10 percent at screening.
- Additional inclusion criteria for participants in the open-label liver biopsy cohort apply:
Key exclusion criteria (16 listed)
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any laboratory safety parameter, at screening, outside the extended laboratory ranges, and considered clinically significant per the principal investigator (see laboratory provided reference ranges for specific values). Of note, re-screening or re-sampling is NOT allowed if the individual has failed one of the exclusion criteria related to the following laboratory parameters:
- ALT >= 3 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >= 3 × ULN
- Bilirubin > 1.5 × ULN
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 |
|---|---|---|
| NNC0581-0001NNC0581-0001 will be administered subcutaneously. | Drug | Cohort 1: NNC0581-0001 (Dose 1), Cohort 2: NNC0581-0001 (Dose 2) |
| Placebo (NNC0581-0001)Placebo matched to NNC0581-0001 will be administered subcutaneously. | Drug | Cohort 1: NNC0581-0001 (Dose 1), Cohort 2: NNC0581-0001 (Dose 2) |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From 1st dose (day 1) until completion of the end of study visit at week 52
Measured as count of events.
3 secondary outcomes
AUC0-32h: The area under the NNC0581-0001 plasma concentration-time curve from time zero to 32 hours after each of the three doses
Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose
Cmax: The maximum concentration of NNC0581-0001 in plasma after each dose of three doses
Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose
Tmax: The time from dose administration to maximum plasma concentration of NNC0581-0001 after each dose of three doses
Time frame: From dosing (day 1 in each treatment period) to 32 hours post dose
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 7 Apr 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 NNC0581-0001 in people with Healthy Volunteers and Hepatic Steatosis, 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 9 inclusion and 16 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 7 Apr 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. 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 (TEAEs) (time frame: From 1st dose (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?
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 7 Apr 2026.