Healthy VolunteersPhase 1NCT07797855
A Study to See How Safe a New Medicine (NNC0705-0002) is in Healthy People
A Phase 1 study testing NNC0705-0002 in people with Healthy Volunteers and Cardiometabolic Diseases, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial summary
This study is testing NNC0705-0002, a new medicine that is being developed for conditions where inflammation may contribute to heart and metabolic health problems. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and… 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?
- NNC0705-0002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Sep 2026to 1 Aug 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 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 kilogram per square metre (kg/m^2) (both inclusive) at screening.
- Body weight: greater than or equal to (≥) 50.0 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 related products.
- Any condition, 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) greater than (>) upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >ULN
- Total bilirubin (TBL) >ULN
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- Creatinine >ULN
- International normalised ratio (INR) >ULN
- High-sensitivity C-reactive protein (hsCRP) greater than (>)5 milligram per liter (mg/L) (males) and >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 acetaminophen/paracetamol and/or nonsteroidal anti-inflammatory drugs at their labelled doses for mild pain; vitamins at their labelled doses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
ICON - location Groningen
Groningen, 9728 NZ
About this study
Official title: A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Target Engagement, and Absorption, Metabolism and Excretion of NNC0705-0002 Following Single and Multiple Oral Administrations of NNC0705-0002 in Healthy Adults
This study is testing NNC0705-0002, a new medicine that is being developed for conditions where inflammation may contribute to heart and metabolic health problems. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and multiple doses in healthy adults. NNC0705-0002 or a placebo (a substance that looks like the study medicine but contains no active medicine), and the treatment they receive may be chosen by chance. NNC0705-0002 is a new medicine that is not yet approved for doctors to prescribe. Depending on the part of the study, participation may last for up to about 7 weeks, including screening, treatment, and follow-up visits.
- Conditions
- Healthy Volunteers, Cardiometabolic Diseases
- Being tested
- NNC0705-0002, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0705-0002Drug
Participants will receive oral capsule of NNC0705-0002.
PlaceboDrug
Participants will receive oral capsule of placebo matched to NNC0705-0002.
| Study group | Role | What they receive |
|---|---|---|
| NNC0705-0002 | Experimental | Participants will receive NNC0705-0002 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed/fasted conditions. Receives: Drug: NNC0705-0002 |
| Placebo | Placebo comparator | Participants will receive placebo matched to NNC0705-0002 administered orally as a SAD, MAD, or under fed/fasted conditions. Receives: 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 time of dosing (day 1) to day 7
Number of TEAEs
Measured as number of events.
Measured: From time of dosing (day 1) to day 13
AUC0-t, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
Measured as hour micromolar (h*μM).
Measured: From pre-dose (day 1 or day 10) to day 6 or day 15
Total recovery of administered radiolabelled NNC0705- 0002-related material (sum urine and faeces)
Measured as percentage (%) of dose.
Measured: From time of dosing (day 1) to no later than day 21
Secondary outcomes (16)
AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as h*μM.
Measured: From pre-dose (day 1) to day 7
Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose
Measured as micromolar (μM).
Measured: From pre-dose (day 1) to day 7
AUCtau, MD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to tau after the last dose
Measured as h*μM.
Measured: From pre-dose (day 7) to tau after last dose (day 8)
Cmax, MD; the maximum observed plasma concentration of NNC0705-0002 after last dose
Measured as μM.
Measured: From pre-dose (day 7) to day 13
AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as h*μM.
Measured: From pre-dose (day 1 or day 10) to day 6 or day 15
Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose
Measured as μM.
Measured: From pre-dose (day 1 or day 10) to day 6 or day 15
Dose-normalised AUC0-∞, SD; the area under the NNC0705-0002 or radiolabelled NNC0705-0002-related material total radioactivity (TRA) plasma concentration-time curve from time 0 to infinity after a single dose divided by dose
Measured as hour micromolar per milligram (h*μM/mg).
Measured: From pre-dose (day 1) to day 17
Total amount of radiolabelled NNC0705-0002- related material excreted in urine
Measured as % of dose.
Measured: From pre-dose (day 1) to day 6
Total amount of radiolabelled NNC0705-0002- related material excreted in faeces
Measured as % of dose.
Measured: From pre-dose (day 1) to day 6
AUC0-∞,14C,SD; area under the plasma concentration-time curve of radiolabelled NNC0705-0002-related material (TRA) from time 0 to infinity after a single dose
Measured as hundreds of nanomoles per litre (h*nmol/L).
Measured: From pre-dose (day 1) to day 9
Number of TEAEs
Measured as number of events.
Measured: From time of dosing (day 1) to day 17
AUC0-∞,14C,SD; area under the plasma concentration-time curve of radiolabelled NNC0705-0002-related material (TRA) from time 0 to infinity after a single dose
Measured as h*nmol/L.
Measured: From pre-dose (day 1) to no later than day 21
Cmax,14C,SD: maximum observed plasma concentration of radiolabelled NNC0705-0002- related material (TRA) after a single dose
Measured as nanomole per litre (nmol/L).
Measured: From pre-dose (day 1) to no later than day 21
AUC0-∞,SD; area under the plasma concentration-time curve of NNC0705- 0002 from time 0 to infinity after a single dose
Measured as h*nmol/L.
Measured: From pre-dose (day 1) to day 5
Cmax,SD: maximum observed plasma concentration of NNC0705-0002 after a single dose
Measured as nmol/L.
Measured: From pre-dose (day 1) to day 5
Number of TEAEs
Measured as number of events.
Measured: From time of dosing (day 1) to day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start2 Sep 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 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
- 112 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
- NCT07797855
- Sponsor's protocol ID
- NN6708-8540
- Other IDs
- U1111-1329-6970, 2026-526205-15
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 30 Sep 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 novonordisktrials.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Target Engagement, and Absorption, Metabolism and Excretion of NNC0705-0002 Following Single and Multiple Oral Administrations of NNC0705-0002 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07797855
- Acronym / sponsor ID
- NN6708-8540
- Conditions
- Healthy Volunteers, Cardiometabolic Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 1 Sep 2026 (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 study is testing NNC0705-0002, a new medicine that is being developed for conditions where inflammation may contribute to heart and metabolic health problems. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, target engagement, and metabolism of NNC0705-0002 after single and multiple doses in healthy adults. NNC0705-0002 or a placebo (a substance that looks like the study medicine but contains no active medicine), and the treatment they receive may be chosen by chance. NNC0705-0002 is a new medicine that is not yet approved for doctors to prescribe. Depending on the part of the study, participation may last for up to about 7 weeks, including screening, treatment, and follow-up visits.
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 |
|---|---|---|
| NNC0705-0002 | Experimental | Drug: NNC0705-0002Participants will receive NNC0705-0002 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed/fasted conditions. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to NNC0705-0002 administered orally as a SAD, MAD, or under fed/fasted conditions. |
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 kilogram per square metre (kg/m^2) (both inclusive) at screening.
- Body weight: greater than or equal to (≥) 50.0 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 (10 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any condition, 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 acetaminophen/paracetamol and/or nonsteroidal anti-inflammatory drugs 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 |
|---|---|---|
| NNC0705-0002Participants will receive oral capsule of NNC0705-0002. | Drug | NNC0705-0002 |
| PlaceboParticipants will receive oral capsule of placebo matched to NNC0705-0002. | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From time of dosing (day 1) to day 7
Measured as number of events.
Number of TEAEs
Time frame: From time of dosing (day 1) to day 13
Measured as number of events.
AUC0-t, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
Time frame: From pre-dose (day 1 or day 10) to day 6 or day 15
Measured as hour micromolar (h*μM).
Total recovery of administered radiolabelled NNC0705- 0002-related material (sum urine and faeces)
Time frame: From time of dosing (day 1) to no later than day 21
Measured as percentage (%) of dose.
16 secondary outcomes
AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) to day 7
Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose
Time frame: From pre-dose (day 1) to day 7
AUCtau, MD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to tau after the last dose
Time frame: From pre-dose (day 7) to tau after last dose (day 8)
Cmax, MD; the maximum observed plasma concentration of NNC0705-0002 after last dose
Time frame: From pre-dose (day 7) to day 13
AUC0-∞, SD; the area under the NNC0705- 0002 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1 or day 10) to day 6 or day 15
Cmax, SD; the maximum observed plasma concentration of NNC0705-0002 after a single dose
Time frame: From pre-dose (day 1 or day 10) to day 6 or day 15
Dose-normalised AUC0-∞, SD; the area under the NNC0705-0002 or radiolabelled NNC0705-0002-related material total radioactivity (TRA) plasma concentration-time curve from time 0 to infinity after a single dose divided by dose
Time frame: From pre-dose (day 1) to day 17
Total amount of radiolabelled NNC0705-0002- related material excreted in urine
Time frame: From pre-dose (day 1) to day 6
Total amount of radiolabelled NNC0705-0002- related material excreted in faeces
Time frame: From pre-dose (day 1) to day 6
AUC0-∞,14C,SD; area under the plasma concentration-time curve of radiolabelled NNC0705-0002-related material (TRA) from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) to day 9
Number of TEAEs
Time frame: From time of dosing (day 1) to day 17
AUC0-∞,14C,SD; area under the plasma concentration-time curve of radiolabelled NNC0705-0002-related material (TRA) from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) to no later than day 21
Cmax,14C,SD: maximum observed plasma concentration of radiolabelled NNC0705-0002- related material (TRA) after a single dose
Time frame: From pre-dose (day 1) to no later than day 21
AUC0-∞,SD; area under the plasma concentration-time curve of NNC0705- 0002 from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) to day 5
Cmax,SD: maximum observed plasma concentration of NNC0705-0002 after a single dose
Time frame: From pre-dose (day 1) to day 5
Number of TEAEs
Time frame: From time of dosing (day 1) to day 23
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.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 NNC0705-0002 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 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: looking for participants now, as of the sponsor's last update on 30 Sep 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?
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 time of dosing (day 1) to day 7). The study lists 4 primary outcomes in all. 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 Sep 2026.