Status:
COMPLETED
A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers (Diabetes Mellitus, Type 2)
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes, as it is expected to lower elevated sugar levels in the blood. The medicine may also lower the appetite. This ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT05363774
Start Date
April 20 2022
End Date
April 2 2024
Last Update
December 31 2025
Active Locations (3)
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1
Novo Nordisk Investigational Site
Søborg, Denmark, 2860
2
Profil GmbH & Co. KG
Mainz, Germany, 55116
3
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460