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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
NNC0519-0130
Placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC0519-0130

Placebo

Arm Description

Escalating multiple doses of NNC0519-0130 administered subcutaneously.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period
Measured in nmol/L.
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as number of events.

Full Information

First Posted
May 12, 2023
Last Updated
September 27, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05870670
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
November 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NNC0519-0130
Arm Type
Experimental
Arm Description
Escalating multiple doses of NNC0519-0130 administered subcutaneously.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Escalating multiple doses of NNC0519-0130 matching placebo administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
NNC0519-0130
Intervention Description
Administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered subcutaneously.
Primary Outcome Measure Information:
Title
AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period
Description
Measured in h*nmol/L.
Time Frame
From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Secondary Outcome Measure Information:
Title
Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period
Description
Measured in nmol/L.
Time Frame
From pre-dose until 24 hours post-dose relative to last dose in each treatment period
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Description
Measured as number of events.
Time Frame
From time of dosing (day 1) until completion of the follow-up visit (day 105)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
130-0004
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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