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NCT Number: NCT05498610

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

This study looks at how the new medicine called NNC0480-0389 works in the body of Chinese men when it is given at different doses together with a fixed dose of semaglutide. Participants will get one injection of NNC0480-0389 and one injection of semaglutide - which dose of NNC0480-0389 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 people 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 in people with type 2 diabetes.

Participants will get 2 injections of the study medicine (one of each). It will be injected with a needle into a skin fold on participants abdomen.

The study will last for a maximum of 72 days. Partcicipants 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

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Chinese male participants aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 20.0 kg/m^2 and 27.9 kg/m^2 (both inclusive).
  • Body weight equal to or greather than 54.0 kg.
  • 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 participant's safety or compliance with the protocol.
  • Glycated haemoglobin (HbA1c) geather han or equal to 6.5 % (48 mmol/mol) at screening.
  • Use of prescription medicinal products or non-prescription drugs (including Chinese traditional medicine or local medicine), except routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening.
  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Treatment and study plan

NNC0480 0389

Drug

Participants will get 1 injections of NNC04800389. It will be injected with a needle into a skin fold on the abdomen.

The study will last for a maximum of 72 days

semaglutide

Drug

Participants will get 1 injections of semaglutide. It will be injected with a needle into a skin fold on the abdomen.

The study will last for a maximum of 72 days

Primary outcomes

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

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

    measured in hnmol^L

  2. Cmax,NNC0480-0389,SD Maximum plasma concentration of NNC0480-0389 after 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

Secondary outcomes

  1. AUC0-∞,sema,SD Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose

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

    measured in hnmol^L

  2. Cmax,sema,SD The maximum plasma concentration of semaglutide after 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 Pharmacokinetic Properties of Subcutaneously co Administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Chinese Male Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2022
Registry last updated
Dec 26, 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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