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Healthy Volunteers - Liver DiseasesPhase 1NCT06133270

A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.

A Phase 1 study testing NNC0560-0004 in people with Healthy Volunteers - Liver Diseases, run by Novo Nordisk A/S at 1 site 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

In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers. Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance. 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 - Liver Diseases
What is being tested?
NNC0560-0004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteUnited Kingdom
Study dates
13 Nov 2023to 4 Jul 2024
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, both genders aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body Mass Index (BMI) between 18.5 and 29.9 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 including inflammatory markers performed during the screening visit, as judged by the investigator
  • CYP2D6 phenotype:
  • For Part A and Part B: ultra-rapid (from cohort A3 forward and B1 forward), normal or intermediate CYP2D6 function
  • For Part C: CYP2D6 Poor Metaboliser function

Who cannot join

  • Any disorder/condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Known history of histamine intolerance or severe anaphylactic reactions
  • Abnormal values at screening for any of the following laboratory parameters
  • Aspartate aminotransferase (AST) greater than Upper limit of normal (ULN)+10%.
  • Alanine aminotransferase (ALT) greater than ULN +10%.
  • Bilirubin (except if known Gilbert's syndrome) greater than ULN +10%.
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  • Creatinine greater than ULN.
  • a.eGFR below 90 ml/min/1.73m^2
  • Glycated haemoglobin (HbA1c) greater than or equal to 5.7% (39 mmol/mol).
  • CYP2D6 unknown phenotype

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Northwick Park Hosptial

    Watford, Middlesex, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Phase I, Randomised, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Once-daily Oral Doses of NNC0560-0004 in Healthy Humans, With an Additional Open Label Single Dose Cohort of CYP2D6 Poor Metabolizers.

In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers.

Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance.

This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans.

The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks.

Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.

Being tested
NNC0560-0004, Placebo (NNC0560-0004)

What participants receive

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

  • NNC0560-0004Drug

    NNC0560-0004, Oral administration (taken through the mouth)

  • Placebo (NNC0560-0004)Drug

    Placebo matching NNC0560-0004, Oral administration (taken through the mouth)

Study groups in NCT06133270
Study groupRoleWhat they receive
NNC0560-0004ExperimentalThe study will be conducted in 3 parts. Participants will be randomized to receive NNC0560-0004 in Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) No randomisation - only active treatment in Part C: Single dose
Receives: Drug: NNC0560-0004
Placebo (NNC0560-0004)Placebo comparatorParticipant will be randomized to receive placebo in: Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD)
Receives: Drug: Placebo (NNC0560-0004)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number of treatment-emergent adverse events (TEAE)

    Number of events

    Measured: From pre-dose (day 1) to end of study, Part A (up to day 13)

  2. Part B: Number of treatment-emergent adverse events (TEAE)

    Number of events

    Measured: From pre-dose (day 1) to end of study, Part B (up to day 26)

  3. Part C: Number of treatment-emergent adverse events (TEAE)

    Number of events

    Measured: From pre-dose (day 1) to end of study, Part C (up to day 84)

Secondary outcomes (12)

  1. Part A: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose

    h*nmol/L

    Measured: From pre-dose (day 1) to end of study, Part A (up to day 13)

  2. Part A: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose

    nmol/L

    Measured: From pre-dose (day 1) to end of study, Part A (up to day 13)

  3. Part A: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose

    hour

    Measured: From pre-dose (day 1) to end of study, Part A (up to day 13)

  4. Part A:t½, SD: the terminal half-life of NNC0560-0004 after a single dose

    hour

    Measured: From pre-dose (day 1) to end of study, Part A (up to day 13)

  5. Part B: AUC0-24h, MD: the area under the NNC0560-0004 plasma concentration-time curve in the dosing interval after last dosing

    h*nmol/L

    Measured: From pre-dose on day 14 until end of study, Part B (up to day 26) (24 hours post-dose)

  6. Part B: Cmax, MD: the maximum plasma concentration of NNC0560-0004 after last dosing

    nmol/L

    Measured: From pre-dose on day 14 to end of study, Part B (up to day 26)

  7. Part B:tmax, MD: the time to maximum concentration of NNC0560-0004 after last dosing

    hour

    Measured: From pre-dose on day 14 to end of study, Part B (up to day 26)

  8. Part B:t½, MD: the terminal half-life of NNC0560-0004 after last dosing

    hour

    Measured: From pre-dose on day 14 to end of study, Part B (up to day 26)

  9. Part C: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose

    h*nmol/L

    Measured: From pre-dose (day 1) to end of study, Part C (up to day 84)

  10. Part C: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose

    nmol/L

    Measured: From pre-dose (day 1) to end of study, Part C (up to day 84)

  11. Part C: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose

    hour

    Measured: From pre-dose (day 1) to end of study, Part C (up to day 84)

  12. Part C: t½, SD: the terminal half-life of NNC0560-0004 after a single dose

    hour

    Measured: From pre-dose (day 1) to end of study, Part C (up to day 84)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2023
  2. Study start13 Nov 2023
  3. Primary completion4 Jul 2024
  4. Study completion4 Jul 2024

Resources

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06133270
Sponsor's protocol ID
NN6561-7567
Other IDs
U1111-1285-1593
Status last verified
Aug 2025
First submitted
8 Nov 2023
Last updated
20 Aug 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0560-0004 in people with Healthy Volunteers - Liver Diseases, 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 6 inclusion and 10 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 20 Aug 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 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. 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?

Part A: Number of treatment-emergent adverse events (TEAE) (time frame: From pre-dose (day 1) to end of study, Part A (up to day 13)). 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?

On the ClinicalTrials.gov record for NCT06133270.

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 20 Aug 2025.

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