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

Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males

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.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: NNC0194-0499; Drug: NNC0194-0499; Drug: NC0194-0499

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250062
      • Jinan Central Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0194-0499 12 mg; Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1.	Drug: NNC0194-0499; Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.; Drug: NNC0194-0499; Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Experimental: NNC0194-0499 30 mg; Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.	Drug: NNC0194-0499; Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.; Drug: NNC0194-0499; Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Experimental: NNC0194-0499 96 mg; Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.	Drug: NC0194-0499; Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum	Measured in nmol/L.	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	Measured in hours.	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	Measured in hours.	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	Measured in liters per hour (L/h).	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase	Measured in liters (L).	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in triglycerides	Measured in Percent change.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in high-density lipoprotein (HDL) cholesterol	Measured in Percent change.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in low-density lipoprotein (LDL) cholesterol	Measured in Percent change.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose	Measured in nmol h/L.	From Day 1 (pre-dose) until Day 7 (168 hours)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

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: NN9500-4796; U1111-1267-4230 (Other Identifier: 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