Test of NNC0497-0040 in healthy adults, people with overweight/obesity, and adults with type 1 diabetes with overweight
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
Run by Novo Nordisk A/S · NCT07578584 · Data updated 2026-11-12
This study tests whether NNC0497-0040 is safe and tolerable and can help people who are healthy, those with overweight or obesity, and those with type 1 diabetes and overweight or obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 146 (estimated) |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Neuss) |
| Status | Recruiting |
| Started | May 7, 2026 |
| Main results expected | February 18, 2028 |
| Study ends | February 18, 2028 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07578584 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–55 with BMI 18.5–29.9 kg/m2, generally healthy by screening, including those with overweight/obesity and a subset with type 1 diabetes and overweight/obesity.
✕Probably not a fit
Participants with significant medical conditions or HbA1c ≥ 6.5% at screening or those unable to adhere to safety restrictions may not benefit from the treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional trial evaluates the safety, tolerability, and potential signals of efficacy for NNC0497-0040 versus placebo over up to 29 weeks in adults who are healthy or have overweight/obesity, including a subgroup with type 1 diabetes and overweight/obesity. Participants are randomized to receive either the investigational drug or placebo and will undergo routine safety assessments, biomarker measurements, and follow-up visits. The study includes male and female adults aged 18–55 with BMI 18.5–29.9 kg/m2 and excludes individuals with conditions or therapies that may affect safety or compliance. Lead sponsor is Novo Nordisk A/S, with recruitment at Profil Institut für Stoffwechselforschung GmbH in Neuss, Germany.
Why it matters
Potential benefit: If successful, participants could experience insights into the safety and potential benefits of NNC0497-0040 for weight- and diabetes-related metabolic health.
How similar studies have gone: Prior Phase 1/early studies of related agents have shown safety signals with tolerability acceptable for progression to later phases, but this specific compound is being tested in a broader population.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany Recruiting
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.