A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian 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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2021-04-27

Brief Summary

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This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men.

Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499.

Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach.

The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).

The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.

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Detailed Description

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Conditions

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Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The present trial is split into two parts reflecting the two trial populations: Japanese subjects and non-Asian subjects. For the Japanese part, it is designed as a randomised, placebo-controlled, double-blinded within cohorts, parallel group, single-dose trial. The non-Asian part is run in parallel to the Japanese part in an open design

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The non-Asian part is run in parallel to the Japanese part in an open design. The Japanese part is double-blinded. Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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NN0194-0499

Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo, Asian participants will only receive NNC0194-0499. There will be 3 cohorts with escalating dose levels. There should be at least 4 days between dose administration of the last participant in a dose level cohort and dose administration of the first participant in the following dose level cohort.

Group Type EXPERIMENTAL

NNC0194-0499

Intervention Type DRUG

1 single dose administered subcutaneously (s.c. - under the skin)

Placebo

Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0194-0499 )

Intervention Type DRUG

1 single dose administered subcutaneously (s.c. - under the skin).

Interventions

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NNC0194-0499

1 single dose administered subcutaneously (s.c. - under the skin)

Intervention Type DRUG

Placebo (NNC0194-0499 )

1 single dose administered subcutaneously (s.c. - under the skin).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male, aged 20-55 years (both inclusive) at the time of signing informed consent
* For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent
* Body mass index (BMI) between 23.0 and 34.9 kg/m\^2 (both inclusive)
* Body weight greater than or equal to 60 kg

Exclusion Criteria

* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes