A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men

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

2021-05-18

Study Completion Date

2021-07-20

Brief Summary

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This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment participants get is decided by chance. NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities. Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in patients with type 2 diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants will have 10 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.

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Detailed Description

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Conditions

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Healthy Volunteers Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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1.7 mg NNC0480-0389 + 0.5 mg Semaglutide

Participants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Group Type EXPERIMENTAL

NNC0480-0389

Intervention Type DRUG

A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.

Semaglutide

Intervention Type DRUG

A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.

Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide)

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0480-0389)

Intervention Type DRUG

A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.

Placebo (Semaglutide)

Intervention Type DRUG

A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

8.6 mg NNC0480-0389 + 0.5 mg Semaglutide

Participants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Group Type EXPERIMENTAL

NNC0480-0389

Intervention Type DRUG

A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.

Semaglutide

Intervention Type DRUG

A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.

Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0480-0389)

Intervention Type DRUG

A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.

Placebo (Semaglutide)

Intervention Type DRUG

A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

30 mg NNC0480-0389 + 0.5 mg Semaglutide

Participants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Group Type EXPERIMENTAL

NNC0480-0389

Intervention Type DRUG

A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.

Semaglutide

Intervention Type DRUG

A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.

Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0480-0389)

Intervention Type DRUG

A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.

Placebo (Semaglutide)

Intervention Type DRUG

A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

Interventions

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NNC0480-0389

A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.

Intervention Type DRUG

Placebo (NNC0480-0389)

A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.

Intervention Type DRUG

Semaglutide

A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.

Intervention Type DRUG

Placebo (Semaglutide)

A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male aged 20-55 years (both inclusive) at the time of signing the informed consent.
* Both parents of Japanese descent.
* Body mass index between 20.0 kg/m\^2 and 24.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy 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

* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
* Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes