Healthy VolunteersPhase 1NCT07029568
A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy People
A Phase 1 study testing NNC0705-0001 in people with Healthy Volunteers and Chronic Kidney Disease, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial summary
The study is testing a new study medicine (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases. 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, Chronic Kidney Disease
- What is being tested?
- NNC0705-0001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jun 2025to 10 Dec 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 kilogram per meter square (kg/m^2) (both inclusive) at screening.
- Body weight: greater than or equal to (≥) 50 kilogram (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 (BIL) > ULN; Creatinine > ULN; International normalized ratio (INR) > ULN; High-Sensitivity C-Reactive Protein (hsCRP) > 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 paracetamol 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 in Human Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Target Engagement of Single and Multiple Oral Administrations of NNC0705-0001 in Healthy Adults
The study is testing a new study medicine (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in our body, and what our body does to the study medicine. The participant will either get NNC0705-0001 or placebo (a "dummy medicine" without the active ingredient). Which treatment the participant gets is decided by chance. The study consists of 3 parts: PART A - single ascending dose (SAD); PART B - multiple ascending doses (MAD) and PART C - food effect (FE) on the pharmacokinetic (PK) properties of NNC0705-0001 and will last about 35 days (PART A) and 41 days (PART B and C).
- Conditions
- Healthy Volunteers, Chronic Kidney Disease
- Being tested
- NNC0705-0001, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0705-0001Drug
NNC0705-0001 will be administered orally.
PlaceboDrug
Placebo matching NNC0705-0001 will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: NNC0705-0001 | Experimental | Participants will receive 6 different single ascending doses of NNC0705-0001 via oral administration. Receives: Drug: NNC0705-0001 |
| Part A: Placebo | Placebo comparator | Participants will receive single ascending dose of placebo matching NNC0705-0001 via oral administration. Receives: Drug: Placebo |
| Part B: NNC0705-0001 | Experimental | Participants will receive 4 different multiple ascending doses of NNC0705-0001 via oral administration. Receives: Drug: NNC0705-0001 |
| Part B: Placebo | Placebo comparator | Participants will receive multiple ascending doses of placebo matching NNC0705-0001 via oral administration. Receives: Drug: Placebo |
| Part C: NNC0705-0001 | Experimental | Participants will receive 2 separate single doses of NNC0705-0001 at a previously safety-cleared dose level in PART A, either in a fed or fasted state. Receives: Drug: NNC0705-0001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PART A: Number of treatment emergent adverse events (TEAE)
Measured in number of events.
Measured: From time of dosing (day 1) to end of study (day 7)
PART B: Number of TEAEs
Measured in number of events.
Measured: From time of dosing (day 1) to end of study (day 13)
AUC, SD; the area under the NNC0705-0001 plasma concentration-time curve after a single dose
Measured in Hour x Micromole (hr×μM).
Measured: From pre-dose (day 1 or day 8) to day 2 or day 9
Secondary outcomes (7)
PART A: AUC0-t, SD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
Measured in hr×μM.
Measured: From pre-dose (day 1) to day 5
PART A: AUC0-∞, SD; the area under the NNC0705-0001 plasma concentration-time curve from time 0 to infinity after a single dose
Measured in hr×μM.
Measured: From pre-dose (day 1) to day 5
PART A: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose
Measured in micromole (μM).
Measured: From pre-dose (day 1) to day 5
PART B: AUCtau, MD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to tau after the last dose
Measured in hr×μM.
Measured: From pre-dose (day 7) to end of study (day 13)
PART B: Cmax, MD; the maximum plasma concentration of NNC0705-0001 after last dose
Measured in μM.
Measured: From pre-dose (day 7) to end of study (day 13)
PART C: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose
Measured in μM.
Measured: From pre-dose (day 1 or day 8) to day 2 or day 9
PART C: Number of TEAEs
Measured in number of events.
Measured: From time of dosing (day 1) to end of study (day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start13 Jun 2025
- Primary completion4 Nov 2025
- Study completion10 Dec 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 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
- NCT07029568
- Sponsor's protocol ID
- NN6705-8141
- Other IDs
- U1111-1315-6842, 2024-519478-38
- Status last verified
- Mar 2026
- First submitted
- 11 Jun 2025
- Last updated
- 11 Mar 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 11 Mar 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, and Target Engagement of Single and Multiple Oral Administrations of NNC0705-0001 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07029568
- Acronym / sponsor ID
- NN6705-8141
- Conditions
- Healthy Volunteers, Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 19 Jun 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 study is testing a new study medicine (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases. The aim of this study is to see if the study medicine is safe, how it works in our body, and what our body does to the study medicine. The participant will either get NNC0705-0001 or placebo (a "dummy medicine" without the active ingredient). Which treatment the participant gets is decided by chance. The study consists of 3 parts: PART A - single ascending dose (SAD); PART B - multiple ascending doses (MAD) and PART C - food effect (FE) on the pharmacokinetic (PK) properties of NNC0705-0001 and will last about 35 days (PART A) and 41 days (PART B and C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: NNC0705-0001 | Experimental | Drug: NNC0705-0001Participants will receive 6 different single ascending doses of NNC0705-0001 via oral administration. |
| Part A: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive single ascending dose of placebo matching NNC0705-0001 via oral administration. |
| Part B: NNC0705-0001 | Experimental | Drug: NNC0705-0001Participants will receive 4 different multiple ascending doses of NNC0705-0001 via oral administration. |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive multiple ascending doses of placebo matching NNC0705-0001 via oral administration. |
| Part C: NNC0705-0001 | Experimental | Drug: NNC0705-0001Participants will receive 2 separate single doses of NNC0705-0001 at a previously safety-cleared dose level in PART A, either in a fed or fasted state. |
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 meter square (kg/m^2) (both inclusive) at screening.
- Body weight: greater than or equal to (≥) 50 kilogram (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 (4 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; Alanine Aminotransferase (ALT) greater than (>) Upper limit of normal (ULN); Aspartate aminotransferase (AST) > ULN; Total Bilirubin (BIL) > ULN; Creatinine > ULN; International normalized ratio (INR) > ULN; High-Sensitivity C-Reactive Protein (hsCRP) > 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 paracetamol 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 |
|---|---|---|
| NNC0705-0001NNC0705-0001 will be administered orally. | Drug | Part A: NNC0705-0001, Part B: NNC0705-0001, Part C: NNC0705-0001 |
| PlaceboPlacebo matching NNC0705-0001 will be administered orally. | Drug | Part A: Placebo, Part B: Placebo |
Primary outcome
PART A: Number of treatment emergent adverse events (TEAE)
Time frame: From time of dosing (day 1) to end of study (day 7)
Measured in number of events.
PART B: Number of TEAEs
Time frame: From time of dosing (day 1) to end of study (day 13)
Measured in number of events.
AUC, SD; the area under the NNC0705-0001 plasma concentration-time curve after a single dose
Time frame: From pre-dose (day 1 or day 8) to day 2 or day 9
Measured in Hour x Micromole (hr×μM).
7 secondary outcomes
PART A: AUC0-t, SD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration after a single dose
Time frame: From pre-dose (day 1) to day 5
PART A: AUC0-∞, SD; the area under the NNC0705-0001 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) to day 5
PART A: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose
Time frame: From pre-dose (day 1) to day 5
PART B: AUCtau, MD; the area under the NN0705-0001 plasma concentration-time curve from time 0 to tau after the last dose
Time frame: From pre-dose (day 7) to end of study (day 13)
PART B: Cmax, MD; the maximum plasma concentration of NNC0705-0001 after last dose
Time frame: From pre-dose (day 7) to end of study (day 13)
PART C: Cmax, SD; the maximum plasma concentration of NNC0705-0001 after a single dose
Time frame: From pre-dose (day 1 or day 8) to day 2 or day 9
PART C: Number of TEAEs
Time frame: From time of dosing (day 1) to end of study (day 12)
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 11 Mar 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Screening Protocol
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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
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 NNC0705-0001 in people with Healthy Volunteers and Chronic Kidney Disease, 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 4 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 11 Mar 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?
PART A: Number of treatment emergent adverse events (TEAE) (time frame: From time of dosing (day 1) to end of study (day 7)). 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?
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 11 Mar 2026.