Healthy VolunteersPhase 1NCT06336005
A Study to See How Safe a New Medicine (NNC6022-0001) is in Healthy People
A Phase 1 study testing NNC6022-0001 in people with Healthy Volunteers and Cardiometabolic Diseases, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial summary
The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine. 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, Cardiometabolic Diseases
- What is being tested?
- NNC6022-0001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2024to 17 Feb 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
- Men or women of non-childbearing potential.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 to 29.9 kg/m^2 (both inclusive) at screening.
- Body Weight: Greater than or equal to 50 kg 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
- Known or suspected hypersensitivity to study intervention(s) or similar products.
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:.
- Alanine Aminotransferase (ALT) above upper normal limit (UNL)
- Aspartate aminotransferase (AST) above UNL
- Total Bilirubin (BL) above UNL
Show all 12Show fewer
- Creatinine above UNL
- International normalized ratio (INR) above UNL
- Fibrinogen outside normal range of 1.6 - 4.2 gram pr. Liter (g/L)
- C-reactive protein (CRP) above 5 milligram pr. Liter (mg/L) (males) and above 8 mg/L (females)
- Use of prescription medicinal products or vaccines within 14 days before dosing and/or non prescription medicinal products within 7 days before dosing.
- Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Doses of NNC6022-0001 in Healthy Adults.
The study is testing a new study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.
The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.
Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
The study will last for about 10 months in total.
- Conditions
- Healthy Volunteers, Cardiometabolic Diseases
- Being tested
- NNC6022-0001, Placebo (NNC6022-0001)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC6022-0001Drug
Participants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to seven cohorts.
Placebo (NNC6022-0001)Drug
Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to seven cohorts
| Study group | Role | What they receive |
|---|---|---|
| NNC6022-0001 | Experimental | Participants will be randomised to NNC6022-0001. Receives: Drug: NNC6022-0001 |
| Placebo (NNC6022-0001) | Placebo comparator | Participants will be randomised to placebo. Receives: Drug: Placebo (NNC6022-0001) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAE)
Number of events
Measured: From time of dosing (Day 1) to end of study (Day 14)
Secondary outcomes (4)
AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
Hours*micrometer (hr×µM)
Measured: From pre-dose (Day 1) to end of exposure (Day 7)
AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose
Hours*micrometer (hr×µM)
Measured: From pre-dose (Day 1) to end of exposure (Day 7)
Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose
Micrometer (µM)
Measured: From pre-dose (Day 1) to end of exposure (Day 7)
IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline
Percentage (%)
Measured: From pre-dose (Day 1) to estimated tmax (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start28 Mar 2024
- Primary completion10 Feb 2025
- Study completion17 Feb 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
- Parallel groups
- 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
- NCT06336005
- Sponsor's protocol ID
- NN6022-7683
- Other IDs
- U1111-1290-1002, 2023-505026-34, 2023
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Target Engagement of Single Doses of NNC6022-0001 in Healthy Adults.
- ClinicalTrials.gov ID
- NCT06336005
- Acronym / sponsor ID
- NN6022-7683
- Conditions
- Healthy Volunteers, Cardiometabolic Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 28 Mar 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 study medicine, which is being tested as a potential medicine to treat cardiometabolic diseases.
The aim of this study is to see if the study medicine is safe, how it works in participants body, and what the body does to the study medicine.
Participants will either get NNC6022-0001 (the new study medicine) or placebo (a "dummy medicine" without the active ingredient). Which treatment participants get is decided by chance. The study medicine is a potential new medicine which cannot be prescribed by doctors.
The study will last for about 10 months in total.
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 |
|---|---|---|
| NNC6022-0001 | Experimental | Drug: NNC6022-0001Participants will be randomised to NNC6022-0001. |
| Placebo (NNC6022-0001) | Placebo comparator | Drug: Placebo (NNC6022-0001)Participants will be randomised to placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men or women of non-childbearing potential.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 to 29.9 kg/m^2 (both inclusive) at screening.
- Body Weight: Greater than or equal to 50 kg 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 (12 listed)
- Known or suspected hypersensitivity to study intervention(s) or similar products.
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values:.
- Use of prescription medicinal products or vaccines within 14 days before dosing and/or non prescription medicinal products within 7 days before dosing.
- Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
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 |
|---|---|---|
| NNC6022-0001Participants will recieve single ascending dose (SAD) of NNC6022-0001. Dose is given in escalating manner for up to seven cohorts. | Drug | NNC6022-0001 |
| Placebo (NNC6022-0001)Participants will recieve single ascending dose (SAD) of placebo. Placebo is given in escalating manner for up to seven cohorts | Drug | Placebo (NNC6022-0001) |
Primary outcome
Number of treatment emergent adverse events (TEAE)
Time frame: From time of dosing (Day 1) to end of study (Day 14)
Number of events
4 secondary outcomes
AUC0-t, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
Time frame: From pre-dose (Day 1) to end of exposure (Day 7)
AUC0-∞, SD; the area under the NNC6022 0001 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (Day 1) to end of exposure (Day 7)
Cmax, SD; the maximum plasma concentration of NNC6022 0001 after a single dose
Time frame: From pre-dose (Day 1) to end of exposure (Day 7)
IL-1β, SD; ratio of <Timepoint> (time of the maximal plasma concentration of NNC6022 0001) to baseline
Time frame: From pre-dose (Day 1) to estimated tmax (Day 1)
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 30 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 NNC6022-0001 in people with Healthy Volunteers and Cardiometabolic Diseases, 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 5 inclusion and 12 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 30 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) (time frame: From time of dosing (Day 1) to end of study (Day 14)). 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 30 Jun 2026.