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Completed

NCT Number: NCT04878406

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

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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Key information

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0480-0389

Drug

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

Placebo (NNC0480-0389)

Drug

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

semaglutide

Drug

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

Placebo (semaglutide)

Drug

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

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 43)

    Count of events

Secondary outcomes

  1. AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose

    Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

    Measured in nmol*h/L

  2. Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose

    Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

    Measured in nmol/L

  3. AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose

    Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

    Measured in nmol*h/L

  4. Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose

    Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

    Measured in nmol/L

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 7, 2021
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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