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NCT07578584RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
146 (estimated)
First submitted
5 May 2026
Start date
7 May 2026
Primary completion date
18 Feb 2028
Lead sponsor
Novo Nordisk A/S
NCT number
NCT07578584
EudraCT number
2025-523978-16

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 146
  • From 7 May 2026 to the primary completion date, 18 Feb 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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
  • 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.
  • 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.

Other illness

  • Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • 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.
  • 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).

Lab values

  • Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.
  • HbA1c above or equal to 6.5 percentage (48 millimoles per mole) at screening.
  • 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).

Who the study is looking for

  • 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.
  • 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).

Criteria the registry did not label

  • For SAD cohorts

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Profil Institut für Stoffwechselforschung GmbH
Coordinator of this site? Confirm its status
NeussGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.