A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men

NCT05742919 | Completed Phase 1

• 2 other identifiers: NN9500-4796U1111-1267-4230
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose

  Measured in nanomoles\*hours per liter (nmol h/L).

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

Secondary Outcomes (9)

• AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose

  From Day 1 (pre-dose) until Day 7 (168 hours)

• Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum

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

• tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499

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

• t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499

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

• CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499

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

Study Arms (3)

NNC0194-0499 12 mg

EXPERIMENTAL

Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1.

Drug: NNC0194-0499

NNC0194-0499 30 mg

EXPERIMENTAL

Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.

Drug: NNC0194-0499

NNC0194-0499 96 mg

EXPERIMENTAL

Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.

Drug: NC0194-0499

Interventions

NNC0194-0499 DRUG

Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.

NNC0194-0499 12 mg

NC0194-0499 DRUG

Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.

NNC0194-0499 96 mg

Eligibility Criteria

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

You may qualify if:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m\^2) (both inclusive).
• Body weight greater than or equal to 60 kg.
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

You may not qualify if:

• Known or suspected hypersensitivity to study intervention or related products.
• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250062, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: February 16, 2023
• Primary Completion: June 13, 2023
• Study Completion: June 13, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)