Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2025
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT06567041
Start Date
August 7 2024
End Date
December 10 2025
Last Update
December 31 2025
Active Locations (1)
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1
Parexel International GmbH
Berlin, Germany, 14050