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

NCT ID: NCT05742919

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-16

Study Completion Date

2023-06-13

Brief Summary

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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.

Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NNC0194-0499 12 mg

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

Group Type EXPERIMENTAL

NNC0194-0499

Intervention Type DRUG

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

NNC0194-0499 30 mg

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

Group Type EXPERIMENTAL

NNC0194-0499

Intervention Type DRUG

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

NNC0194-0499 96 mg

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

Group Type EXPERIMENTAL

NC0194-0499

Intervention Type DRUG

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

Interventions

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NNC0194-0499

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

Intervention Type DRUG

NNC0194-0499

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

Intervention Type DRUG

NC0194-0499

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Jinan Central Hospital

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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U1111-1267-4230

Identifier Type: OTHER

Identifier Source: secondary_id

NN9500-4796

Identifier Type: -

Identifier Source: org_study_id

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