Phase
Condition
Diabetes And Hypertension
Diabetes Prevention
Obesity
Treatment
NNC0519-0130
Placebo
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.
Male or female of non-childbearing potential.
Age 18-55 years (both inclusive) at the time of signing the informed consent.
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.
Participants with obesity only:
- Body mass index between 30.0 kilogram per meter square (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, asjudged by the investigator.
Participants with type 2 diabetes with either overweight or obesity:
Body mass index between 27.0 kg/m^2 and 39.9kg/m^2 (both inclusive) at screening.Overweight should be due to excess adipose tissue, as judged by the investigator.
Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days beforescreening.
Glycated haemoglobin (HbA1c) in the range of 6.5 percentage (%) (inclusive) and 9.5% (inclusive).
Exclusion
Exclusion Criteria:
Any condition, except T2D and hypertension, which in the investigator's opinionmight jeopardise participant's safety or compliance with the protocol.
Presence or history of any clinically relevant respiratory, metabolic, renal,hepatic, gastrointestinal, endocrinological conditions (except diabetes mellitus andhypertension).
Presence or history of cardiovascular disease including stable and unstable anginapectoris, myocardial infarction, transient ischaemic attack, stroke, cardiacdecompensation, clinically significant arrhythmias or clinically significantconduction disorders.
Participant is breastfeeding.
Participants with obesity only:
- HbA1c ≥ 6.5 % (48 millimoles per mol [mmol/mol]) at screening.
Participants with type 2 diabetes with either overweight or obesity:
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination.
Recurrent severe hypoglycaemia within the last year as judged by the investigator.
Known hypoglycaemic unawareness as indicated by the investigator according toClarke's questionnaire question 8.
Study Design
Connect with a study center
Parexel International GmbH
Berlin, 14050
GermanySite Not Available
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