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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Non-alcoholic Steatohepatitis

Treatments: Drug: NNC0194-0499; Drug: Placebo (NNC0194-0499 )

Study type: Interventional

Funder types: Industry

Identifiers

NCT04722653

NN9500-4663

U1111-1255-1392 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

NN0194-0499

Experimental group

Description:

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.

Treatment:

Drug: NNC0194-0499

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (NNC0194-0499 )