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

NCT04722653 | Completed Phase 1

• 2 other identifiers: NN9500-4663U1111-1255-1392
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

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

  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

  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

  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

  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

  From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Study Arms (2)

NN0194-0499

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (NNC0194-0499 )

Interventions

NNC0194-0499 DRUG

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

NN0194-0499

Placebo (NNC0194-0499 ) DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 130-0004, Japan

Location

Related Publications (1)

• Dahl K, Friedrichsen MH, Ribel-Madsen R, Hansen JS, Clausen JO, Axelsen M, Palle MS, Lippert SL, Bjorkdahl O, Toubro S, Key C, Andersen B. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Long-Acting FGF21 Analog Zalfermin. Clin Transl Sci. 2025 Dec;18(12):e70435. doi: 10.1111/cts.70435.

  PMID: 41351276 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: February 2, 2021
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)