Clinical trial NCT05870670: A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men
Official title: Investigation of Pharmacokinetics, Safety, and Tolerability of Multiple Subcutaneous Doses of NNC0519-0130 in Japanese and Non-Japanese Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 23.0 kilogram per meter square (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). 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 (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* For Japanese participants: Both parents of Japanese descent.
* For non-Japanese participants: Both parents of Caucasian descent.

Exclusion Criteria:

* 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.
* Glycosylated haemglobin (HbA1c) greater than or equal to 6.5 percent (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 (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.

Primary outcomes:
measure: AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period
timeFrame: From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Secondary outcomes:
measure: Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period
timeFrame: From pre-dose until 24 hours post-dose relative to last dose in each treatment period
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From time of dosing (day 1) until completion of the follow-up visit (day 105)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: SOUSEIKAI Sumida Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: