Healthy ParticipantsPhase 1NCT06069895
Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants
A Phase 1 study testing NNC0113-6856 in people with Healthy Participants, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- NNC0113-6856
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- 4 Oct 2023to 23 Apr 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
- Male or female.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.
- Additional for healthy Japanese participants:
- First generation Japanese (Japanese born participants).
Who cannot join
- HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
- Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values:
- Alanine Aminotransferase (ALT) greater than (>) upper normal limit (UNL) +10%
- Aspartate aminotransferase (AST) > UNL+20%
- Total bilirubin > UNL+20%
- Creatinine > UNL+10%
- International normalised ratio (INR) > UNL
Trial locations and contacts
1 site in 1 country.
About this study
NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.
- Conditions
- Healthy Participants
- Being tested
- NNC0113-6856, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0113-6856Drug
NNC0113-6856 will be administered as oral tablets.
PlaceboDrug
NNC0113-6856 matching placebo will be administered as oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| NNC0113-6856 | Experimental | Participants will receive NNC0113-6856 oral tablets. Receives: Drug: NNC0113-6856 |
| Placebo | Experimental | Participants will receive NNC0113-6856 matching placebo oral tablets. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs)
Measured as number of events.
Measured: From time of first dosing (day 1) until completion of the follow-up visit (day 148)
Secondary outcomes (18)
Part 1 Multiple ascending dose (MAD): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Measured in hours*nanomoles per liter (h*nmol/L).
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Measured in nanomoles per liter(nmol/L).
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Measured in h*nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Measured in nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Measured in h*nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Measured in nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Measured in h*nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Measured in nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Measured in h*nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Measured in nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Measured in h*nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Measured in nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Measured in h*nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Measured in nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Measured in h*nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Measured in nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Measured in h*nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Measured in nmol/L.
Measured: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start4 Oct 2023
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 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
- NCT06069895
- Sponsor's protocol ID
- NN9904-5008
- Other IDs
- U1111-1284-5743
- Status last verified
- Jun 2025
- First submitted
- 29 Sep 2023
- Last updated
- 18 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants
- ClinicalTrials.gov ID
- NCT06069895
- Acronym / sponsor ID
- NN9904-5008
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 6 Oct 2023 (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.
NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC0113-6856 | Experimental | Drug: NNC0113-6856Participants will receive NNC0113-6856 oral tablets. |
| Placebo | Experimental | Drug: PlaceboParticipants will receive NNC0113-6856 matching placebo oral tablets. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.
- First generation Japanese (Japanese born participants).
Key exclusion criteria (7 listed)
- HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
- Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values:
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 |
|---|---|---|
| NNC0113-6856NNC0113-6856 will be administered as oral tablets. | Drug | NNC0113-6856 |
| PlaceboNNC0113-6856 matching placebo will be administered as oral tablets. | Drug | Placebo |
Primary outcome
Number of adverse events (AEs)
Time frame: From time of first dosing (day 1) until completion of the follow-up visit (day 148)
Measured as number of events.
18 secondary outcomes
Part 1 Multiple ascending dose (MAD): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106
Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state
Time frame: From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106
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 18 Jun 2025.
- 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. 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 NNC0113-6856 in people with Healthy Participants, run by Novo Nordisk A/S at 1 site in Germany.
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 7 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 18 Jun 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 Germany. 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?
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 adverse events (AEs) (time frame: From time of first dosing (day 1) until completion of the follow-up visit (day 148)). 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 18 Jun 2025.