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

Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects

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 Overview

• Status: Completed
• Conditions: Non-alcoholic Steatohepatitis
• Intervention / Treatment: Drug: NNC0194-0499; Drug: Placebo (NNC0194-0499 )

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 130-0004
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: NNC0194-0499; 1 single dose administered subcutaneously (s.c. - under the skin)
PLACEBO_COMPARATOR: Placebo; Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo.	Drug: Placebo (NNC0194-0499 ); 1 single dose administered subcutaneously (s.c. - under the skin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs)	Count of events	From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-tz, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time of the last quantifiable sample after a single s.c. administration	h·nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-168h, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration	h·nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration	nmol/L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration	Hours	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
t½, SD: Terminal half-life of NNC0194-0499	Hours	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
CL/FSD: Apparent total serum clearance of NNC0194-0499	L/h	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Vz/FSD: Apparent volume of distribution of NNC0194-0499 in the terminal phase	L	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration	Hours	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2021
• Primary Completion (ACTUAL): April 27, 2021
• Study Completion (ACTUAL): April 27, 2021

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (ACTUAL): January 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NN9500-4663; U1111-1255-1392 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No