New weekly shot aims to tackle weight and type 1 diabetes
NCT ID NCT07578584
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new drug called NNC0497-0040 in healthy people, those with overweight or obesity, and people with type 1 diabetes who are also overweight. The goal is to see if the drug is safe and tolerable when given as a weekly injection. About 146 participants will receive either the drug or a placebo for up to 29 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NNC0497-0040
- What this could lead to
- If successful, this could point toward a new weekly injection to help manage weight and blood sugar in people with type 1 diabetes.
- What could go wrong
- This is an early Phase 1 trial focused on safety, not effectiveness. It is small and may not lead to a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 146 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Profil Institut für Stoffwechselforschung GmbH
RECRUITINGNeuss, 41460, Germany
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