A Research Study of How Safe a New Medicine Called NNC0519 0130 is and to Test Its Effect in People Living With Excess Body Weight With or Without Type 2 Diabetes

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

Inclusion Criteria: - Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities 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 the results of vital signs, electrocardiogram and clinical laboratory tests performed during 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, as judged 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 before screening. - Glycated haemoglobin (HbA1c) in the range of 6.5 percentage (%) (inclusive) and 9.5% (inclusive). Exclusion Criteria: - Any condition, except T2D and hypertension, 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 diabetes mellitus and hypertension). - Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction 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. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. - Recurrent severe hypoglycaemia within the last year as judged by the investigator. - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of adverse events

Secondary Outcome Measures

Name	Time	Method
Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI);Change in 12-lead electrocardiogram, Fridericia heart rate corrected QT interval (QTcF);Area under the NNC0519-0130 plasma concentration-time curve in steady state;Maximum plasma concentration of NNC0519-0130 in steady state