CClinicalTrials.gg
RecruitingNCT07578584Updated Jun 4, 2026

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 interventional study of NNC0497-0040 and Placebo in Type 1 Diabetes (T1D), Overweight and Obesity, sponsored by Novo Nordisk A/S. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Type 1 Diabetes (T1D)
  • Overweight
  • Obesity
  • Healthy Volunteers
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 146 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

For SAD cohorts

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
146 participants (estimated)

Study arms

  • Experimental
    SAD

    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

    Drug: NNC0497-0040 · Drug: Placebo

  • Experimental
    MAD1

    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

    Drug: NNC0497-0040 · Drug: Placebo

  • Experimental
    MAD2

    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

    Drug: NNC0497-0040 · Drug: Placebo

  • Experimental
    MAD3

    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

    Drug: NNC0497-0040 · Drug: Placebo

  • Experimental
    MAD4

    Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.

    Drug: NNC0497-0040 · Drug: Placebo

Interventions

  • DrugNNC0497-0040

    NNC0497-0040 will be administered subcutaneously.

  • DrugPlacebo

    Placebo will be administered subcutaneously.

06

What researchers measure

Primary outcomes

  1. Number of adverse events

    Measured in events

    Time frame: Day 1 up to Week 6

  2. Number of adverse events

    Measured in events

    Time frame: MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25

  3. Number of adverse events

    Measured in events

    Time frame: Day 1 up to Week 25

Secondary outcomes

  1. Area under the serum NNC0497-0040 concentration time curve

    Measured in hours \* nanomoles per litre (h\*nmol/L)

    Time frame: Day 1

  2. Cmax: Maximum observed serum NNC0497-0040 concentration

    Measured in nanomoles per litre (nmol/L)

    Time frame: Day 1

  3. Area under the serum NNC0497-0040 concentration time curve at steady state

    Measured in hours \* nanomoles per litre (h\*nmol/L)

    Time frame: MAD1-2: Week 12; MAD3: Week 20

  4. Cmax: Maximum observed serum NNC0497-0040 concentration at steady state

    Measured in nanomoles per litre (nmol/L)

    Time frame: MAD1-2: Week 12; MAD3: Week 20

  5. Number of severe hypoglycaemic episodes

    Measured in events

    Time frame: Day 1 up to Week 25

  6. AUC: Area under the serum NNC0497-0040 concentration time curve during at steady state

    Measured in hours \* nanomoles per litre (h\*nmol/L)

    Time frame: MAD4: Week 20

  7. Cmax: Maximum observed serum NNC0497-0040 concentration at steady state

    Measured in nanomoles per litre (nmol/L)

    Time frame: MAD4: Week 20

07

Study locations

1 of 1 sites recruiting
  • Profil Institut für Stoffwechselforschung GmbH
    Neuss, 41460, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07578584
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
May 11, 2026
Start date
May 7, 2026
Primary completion
Feb 18, 2028 (estimated)
Completion
Feb 18, 2028 (estimated)
Last update
Jun 4, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency dept. 2834
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion