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

NCT05870670 | Completed Phase 1

• 2 other identifiers: NN9541-4921U1111-1283-0710
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period

  Measured in h\*nmol/L.

  From pre-dose until 24 hours post-dose relative to last dose in each treatment period

Secondary Outcomes (2)

• 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

• Number of Treatment Emergent Adverse Events (TEAEs)

  From time of dosing (day 1) until completion of the follow-up visit (day 105)

Study Arms (2)

NNC0519-0130

EXPERIMENTAL

Escalating multiple doses of NNC0519-0130 administered subcutaneously.

Drug: NNC0519-0130

Placebo

PLACEBO COMPARATOR

Escalating multiple doses of NNC0519-0130 matching placebo administered subcutaneously.

Drug: Placebo

Interventions

NNC0519-0130 DRUG

Administered subcutaneously.

NNC0519-0130

Placebo DRUG

Administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

SOUSEIKAI Sumida Hospital

Tokyo, 130-0004, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: May 15, 2023
• Primary Completion: October 7, 2023
• Study Completion: October 16, 2023
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)