New diabetes drug shows promise in first human tests
NCT ID NCT05363774
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested a new medicine, NNC0519-0130, in 161 people to see if it is safe and how it works in the body. The medicine aims to lower blood sugar and reduce appetite, which could help people with type 2 diabetes and overweight. Participants received either the medicine or a placebo as injections or tablets for up to 18 weeks. The study is complete, and results will guide further research.
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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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161 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Apr 2024
- 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
-
18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
Inclusion Criteria: * Single ascending dose (SAD) part: * Male aged 18-55 years (both inclusive) at screening * Body mass index between 18.5 kilogram per meter square (kg/m\^2) and 27.0 kg/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 * Multiple ascending dose (MAD) part (MAD QD and MAD QW): * Male aged 18-55 years (both inclusive) at screening * Body mass index between 25.0 kg/m\^2 and 39.9 kg/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 * Type 2 diabetes (T2D) part: * Female of non-childbearing potential or male aged 18-64 years (both inclusive) at screening * Body mass index between 25.0 kg/m\^2 and 39.9 kg/m\^2 (both inclusive) at screening * Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening * Treatment naive to antidiabetic drugs or on a stable daily dose(s) of metformin therapy (any metformin formulation any dose) greater than or equal to (\>=) 60 days before screening * Insulin naive. However, short-term insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes * HbA1c in the range of 6.5% (inclusive) and 9.5% (inclusive) Exclusion Criteria: * Single ascending dose (SAD) part: * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening * Any disorder, 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 greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening * Multiple ascending dose (MAD) part (MAD QD and MAD QW): * Any disorder, 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 greater than or equal to (≥) 6.5 % (48 mmol/mol) at screening * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening * Type 2 diabetes (T2D) part: * Any disorder, except for conditions associated with T2D, 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) * Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products * Current treatment with selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
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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.
Contacts and locations
Locations
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Novo Nordisk Investigational Site
Søborg, 2860, Denmark
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Profil GmbH & Co. KG
Mainz, 55116, Germany
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Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
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