A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: NNC0519-0130; Drug: Placebo

• Registration Number: NCT05870670
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-12
• Study Start: 2023-05-15
• Study First Posted: 2023-05-23
• Primary Completion: 2023-10-07
• Study Completion: 2023-10-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0519-0130	NNC0519-0130	Escalating multiple doses of NNC0519-0130 administered subcutaneously.
Placebo	Placebo	Escalating multiple doses of NNC0519-0130 matching placebo administered subcutaneously.

Primary Outcome Measures

Name	Time	Method
AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period	From pre-dose until 24 hours post-dose relative to last dose in each treatment period	Measured in h\*nmol/L.

Secondary Outcome Measures

Name	Time	Method
Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period	From pre-dose until 24 hours post-dose relative to last dose in each treatment period	Measured in nmol/L.
Number of Treatment Emergent Adverse Events (TEAEs)	From time of dosing (day 1) until completion of the follow-up visit (day 105)	Measured as number of events.

Trial Locations

Locations (1)

SOUSEIKAI Sumida Hospital; 🇯🇵 Tokyo, Japan