Phase
Condition
Diabetes And Hypertension
Diabetes Prevention
Diabetes Mellitus, Type 2
Treatment
NNC0519-0130
Placebo (NNC0519-0130)
Clinical Study ID
Ages 18-64 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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, physicalexamination, and the results of vital signs, electrocardiogram and clinicallaboratory 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 theresults of vital signs, electrocardiogram and clinical laboratory tests performedduring 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) atscreening
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 beforescreening
Treatment naive to antidiabetic drugs or on a stable daily dose(s) of metformintherapy (any metformin formulation any dose) greater than or equal to (>=) 60 daysbefore screening
Insulin naive. However, short-term insulin treatment for a maximum of 14 days beforescreening is allowed, as is prior insulin treatment for gestational diabetes
HbA1c in the range of 6.5% (inclusive) and 9.5% (inclusive)
Exclusion
Exclusion Criteria:
Single ascending dose (SAD) part:
Any disorder, which in the investigator's opinion might jeopardise participant'ssafety or compliance with the protocol
Glycosylated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimolesper mole (mmol/mol)) at screening
Use of prescription medicinal products or non-prescription drugs, except routinevitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, anddomperidon, or topical medication not reaching systemic circulation, within 14 daysbefore screening
Any disorder, which in the investigator's opinion might jeopardise participant'ssafety 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 routinevitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, anddomperidon, or topical medication not reaching systemic circulation, within 14 daysbefore screening
Multiple ascending dose (MAD) part (MAD QD and MAD QW):
Any disorder, which in the investigator's opinion might jeopardise participant'ssafety 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 routinevitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid, anddomperidon, or topical medication not reaching systemic circulation, within 14 daysbefore screening
Type 2 diabetes (T2D) part:
Any disorder, except for conditions associated with T2D, which in the investigator'sopinion 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 associatedwith diabetes mellitus)
Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers, growth hormone, non-routinevitamins 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
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Søborg, 2860
DenmarkSite Not Available
Novo Nordisk Investigational Site
Neuss, 41460
GermanyActive - Recruiting
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460
GermanySite Not Available
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