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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2023-10-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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NNC0519-0130

Escalating multiple doses of NNC0519-0130 administered subcutaneously.

Group Type EXPERIMENTAL

NNC0519-0130

Intervention Type DRUG

Administered subcutaneously.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered subcutaneously.

Interventions

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NNC0519-0130

Administered subcutaneously.

Intervention Type DRUG

Placebo

Administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes