Type 1 Diabetes (T1D)Phase 1NCT07578584
A Research Study Investigating the Effect of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and Participants With Type 1 Diabetes With Overweight or Obesity
A Phase 1 study testing NNC0497-0040 in people with Type 1 Diabetes (T1D) and Overweight, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Overweight, Obesity
- What is being tested?
- NNC0497-0040
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteGermany
- Study dates
- 7 May 2026to 18 Feb 2028
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
- Body mass index between 18.5 kilogram per m^2 and 29.9 kilogram per m^2 (both inclusive) 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.
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
- Body mass index between 27.0 kilogram per m^2 and 39.9 kilogram per m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered eligible 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.
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- Male aged 18-55 years (both inclusive) at screening.
- Body mass index between 27.0 kilogram per m^2 and 34.9 kilogram per m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Diagnosed with type 1 diabetes mellitus above or equal to 1 year before screening.
- Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) more than 90 days prior to the day of screening.
- Use of continuous glucose monitoring (CGM) device more than 90 consecutive days prior to the day of screening.
- HbA1c in the range of 7.2percentage - 9.5percentage (both inclusive).
Who cannot join
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.
- Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
- For MAD1-3 cohorts
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
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- HbA1c above or equal to 6.5 percentage (48 millimoles per mole) at screening.
- Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
- For MAD4 cohorts
- Any disorder, unwillingness or inability, except for mild conditions under stable treatment associated with type 1 diabetes (T1D), which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).
- Use of any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening or in the period between screening and randomisation.
- Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers or growth hormone.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
- Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460
About this study
Official title: Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Weekly Doses of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and in Participants With Type 1 Diabetes With Overweight or Obesity
The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.
- Conditions
- Type 1 Diabetes (T1D), Overweight, Obesity, Healthy Volunteers
- Being tested
- NNC0497-0040, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0497-0040Drug
NNC0497-0040 will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| SAD | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. Receives: Drug: NNC0497-0040; Drug: Placebo |
| MAD1 | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. Receives: Drug: NNC0497-0040; Drug: Placebo |
| MAD2 | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. Receives: Drug: NNC0497-0040; Drug: Placebo |
| MAD3 | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. Receives: Drug: NNC0497-0040; Drug: Placebo |
| MAD4 | Experimental | Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. Receives: Drug: NNC0497-0040; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured in events
Measured: Day 1 up to Week 6
Number of adverse events
Measured in events
Measured: MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25
Number of adverse events
Measured in events
Measured: Day 1 up to Week 25
Secondary outcomes (7)
Area under the serum NNC0497-0040 concentration time curve
Measured in hours * nanomoles per litre (h*nmol/L)
Measured: Day 1
Cmax: Maximum observed serum NNC0497-0040 concentration
Measured in nanomoles per litre (nmol/L)
Measured: Day 1
Area under the serum NNC0497-0040 concentration time curve at steady state
Measured in hours * nanomoles per litre (h*nmol/L)
Measured: MAD1-2: Week 12; MAD3: Week 20
Cmax: Maximum observed serum NNC0497-0040 concentration at steady state
Measured in nanomoles per litre (nmol/L)
Measured: MAD1-2: Week 12; MAD3: Week 20
Number of severe hypoglycaemic episodes
Measured in events
Measured: Day 1 up to Week 25
AUC: Area under the serum NNC0497-0040 concentration time curve during at steady state
Measured in hours * nanomoles per litre (h*nmol/L)
Measured: MAD4: Week 20
Cmax: Maximum observed serum NNC0497-0040 concentration at steady state
Measured in nanomoles per litre (nmol/L)
Measured: MAD4: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start7 May 2026
- Primary completion18 Feb 2028 (estimated)
- Study completion18 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies 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
- 146 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
- NCT07578584
- Sponsor's protocol ID
- NN6497-8309
- Other IDs
- U1111-1325-4319, 2025-523978-16, 2025
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 4 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Weekly Doses of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and in Participants With Type 1 Diabetes With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07578584
- Acronym / sponsor ID
- NN6497-8309
- Conditions
- Type 1 Diabetes (T1D), Overweight, Obesity, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 18 Feb 2028 (estimated)
- Study completion
- 18 Feb 2028 (estimated)
- First posted
- 11 May 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.
The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SAD | Experimental | Drug: NNC0497-0040, Drug: PlaceboParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
| MAD1 | Experimental | Drug: NNC0497-0040, Drug: PlaceboParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
| MAD2 | Experimental | Drug: NNC0497-0040, Drug: PlaceboParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
| MAD3 | Experimental | Drug: NNC0497-0040, Drug: PlaceboParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
| MAD4 | Experimental | Drug: NNC0497-0040, Drug: PlaceboParticipants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
- Body mass index between 18.5 kilogram per m^2 and 29.9 kilogram per m^2 (both inclusive) 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.
- Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.
- Body mass index between 27.0 kilogram per m^2 and 39.9 kilogram per m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Key exclusion criteria (15 listed)
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.
- Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.
- For MAD1-3 cohorts
- Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
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 |
|---|---|---|
| NNC0497-0040NNC0497-0040 will be administered subcutaneously. | Drug | MAD1, MAD2, MAD3, MAD4, SAD |
| PlaceboPlacebo will be administered subcutaneously. | Drug | MAD1, MAD2, MAD3, MAD4, SAD |
Primary outcome
Number of adverse events
Time frame: Day 1 up to Week 6
Measured in events
Number of adverse events
Time frame: MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25
Measured in events
Number of adverse events
Time frame: Day 1 up to Week 25
Measured in events
7 secondary outcomes
Area under the serum NNC0497-0040 concentration time curve
Time frame: Day 1
Cmax: Maximum observed serum NNC0497-0040 concentration
Time frame: Day 1
Area under the serum NNC0497-0040 concentration time curve at steady state
Time frame: MAD1-2: Week 12; MAD3: Week 20
Cmax: Maximum observed serum NNC0497-0040 concentration at steady state
Time frame: MAD1-2: Week 12; MAD3: Week 20
Number of severe hypoglycaemic episodes
Time frame: Day 1 up to Week 25
AUC: Area under the serum NNC0497-0040 concentration time curve during at steady state
Time frame: MAD4: Week 20
Cmax: Maximum observed serum NNC0497-0040 concentration at steady state
Time frame: MAD4: Week 20
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 4 Jun 2026.
- 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.
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 NNC0497-0040 in people with Type 1 Diabetes (T1D) and Overweight, 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 12 inclusion and 15 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 4 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 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?
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 adverse events (time frame: Day 1 up to Week 6). 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 4 Jun 2026.