Healthy ParticipantsPhase 1NCT06284798
A Research Study of a New Medicine (NNC0650-0013) in Healthy Men
A Phase 1 study testing NNC0650-0013 A in people with Healthy Participants, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Healthy Participants
- What is being tested?
- NNC0650-0013 A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jan 2024to 25 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
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
- Considered to be otherwise 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
- Any disorder, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants
This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.
- Conditions
- Healthy Participants
- Being tested
- NNC0650-0013 A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0650-0013 ADrug
NNC0650-0013 will be administered subcutaneously or intravenously.
PlaceboDrug
Subcutaneous administration.
| Study group | Role | What they receive |
|---|---|---|
| NNC0650-0013: Subcutaneous dose | Experimental | Participants will receive NNC0650-0013 subcutaneously in an ascending dose manner. Receives: Drug: NNC0650-0013 A |
| Placebo | Placebo comparator | Participants will receive matching placebo to NNC0650-0013 subcutaneously. Receives: Drug: Placebo |
| NNC0650-0013: Intravenous dose | Experimental | Participants will receive NNC0650-0013 in an ascending dose manner intravenously. Receives: Drug: NNC0650-0013 A |
What is being measured
The primary outcome is the main question the study is designed to answer.
S.C. Cohort: Number of treatment emergent adverse events (TEAEs)
Measured as number of events.
Measured: From time of dosing (day 1) until completion of the follow-up visit (day 75)
Secondary outcomes (10)
S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose
Measured as hours nanomoles per liter (h*nmol/L).
Measured: From pre-dose (day 1) until completion of the follow up visit (day 75)
S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose
Measured as nanomoles per liter (nmol/L).
Measured: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as h*nmol/L.
Measured: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose
Measured as nanomoles per liter (nmol/L).
Measured: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose
Measured as h*nmol/L.
Measured: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose
Measured as nanomoles per liter (nmol/L).
Measured: From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as h*nmol/L.
Measured: From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as h*nmol/L.
Measured: From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as h*nmol/L.
Measured: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered
Measured as hours nanomoles per milligram (h*nmol/mg).
Measured: From pre-dose (day1) until completion of the follow-up visit (day 75)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start29 Jan 2024
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
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
- 11 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
- NCT06284798
- Sponsor's protocol ID
- NN9650-5027
- Other IDs
- 2023-506134-79, U1111-1291-7535, 2023
- Status last verified
- Nov 2025
- First submitted
- 22 Feb 2024
- Last updated
- 5 Dec 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Subcutaneous Single Ascending Doses of NNC0650-0013 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06284798
- Acronym / sponsor ID
- NN9650-5027
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 29 Feb 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.
This study is testing a new study medicine which may be used to treat people with type 2 diabetes. NNC0650-0013 is a new medicine, which cannot be prescribed by doctors. The purpose of the study is to see if the new study medicine is safe, and how it works in participants body. Participants will get a single dose of the study medicine either as injection(s) under the skin or into a vein. The injection will be given by the study staff. If participants are chosen to get the study medicine as injections under the skin, participants will either get NNC0650-0013 or placebo (a "dummy medicine" without any active ingredients). Which treatment participants get is decided by chance. Participants will be required to fast overnight 3 times during the study. The study will last between 11 and 17 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NNC0650-0013: Subcutaneous dose | Experimental | Drug: NNC0650-0013 AParticipants will receive NNC0650-0013 subcutaneously in an ascending dose manner. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to NNC0650-0013 subcutaneously. |
| NNC0650-0013: Intravenous dose | Experimental | Drug: NNC0650-0013 AParticipants will receive NNC0650-0013 in an ascending dose manner intravenously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Body mass index between 24.0 and 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
- Considered to be otherwise 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 (2 listed)
- Any disorder, unwillingness or inability, which, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole (mmol/mol)) at screening.
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 |
|---|---|---|
| NNC0650-0013 ANNC0650-0013 will be administered subcutaneously or intravenously. | Drug | NNC0650-0013: Intravenous dose, NNC0650-0013: Subcutaneous dose |
| PlaceboSubcutaneous administration. | Drug | Placebo |
Primary outcome
S.C. Cohort: Number of treatment emergent adverse events (TEAEs)
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 75)
Measured as number of events.
10 secondary outcomes
S.C. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) until completion of the follow up visit (day 75)
S.C. Cohort: Cmax,0188,SD: Maximum plasma concentration of NNC0519-0188 after a single dose
Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: Cmax,0013,SD: Maximum observed plasma concentration of NNC0650-0013 after a single dose
Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031plasma concentration time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. Cohort: Cmax,0031,SD: Maximum observed plasma concentration of NNC0650-0031 after a single dose
Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0188,SD: Area under the NNC0519-0188 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0013,SD: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
I.V. Cohort: AUC0-∞,0031,SD: Area under the NNC0650-0031 plasma concentration-time curve from time 0 to infinity after a single dose
Time frame: From pre-dose (day 1) until completion of the follow-up visit (day 75)
S.C. and I.V. Cohort: AUC0-∞,0013,SD/dose: Area under the NNC0650-0013 plasma concentration-time curve from time 0 to infinity after a single dose divided by the dose administered
Time frame: From pre-dose (day1) until completion of the follow-up visit (day 75)
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 5 Dec 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 NNC0650-0013 A 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 4 inclusion and 2 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 5 Dec 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. 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?
S.C. Cohort: Number of treatment emergent adverse events (TEAEs) (time frame: From time of dosing (day 1) until completion of the follow-up visit (day 75)). 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 5 Dec 2025.