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

Novo Nordisk A/S42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Non-alcoholic Steatohepatitis

Interventions

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of treatment emergent adverse events (TEAEs)

Count of events

Time frame: From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)

Secondary Outcomes

AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration

h·nmol/L