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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Drug: NNC0194-0499; Drug: NC0194-0499

Study type: Interventional

Funder types: Industry

Identifiers

NCT05742919

U1111-1267-4230 (Other Identifier)

NN9500-4796

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

NNC0194-0499 12 mg

Experimental group

Description:

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

Treatment:

Drug: NNC0194-0499

Drug: NNC0194-0499

NNC0194-0499 30 mg

Experimental group

Description:

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

Treatment:

Drug: NNC0194-0499

Drug: NNC0194-0499

NNC0194-0499 96 mg

Experimental group

Description:

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

Treatment:

Drug: NC0194-0499