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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Investigation of Pharmacokinetic Properties of Subcutaneously co Administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Chinese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498610
• Other study ID #: NN9389-4774
• Secondary ID: U1111-1264-4516
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2022
• Est. completion date: October 12, 2022

Study information

• Verified date: December 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• NNC0480 0389
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
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

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-8,NNC0480-0389,SD Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity after a single dose (SD)	measured in hnmol^L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Primary	Cmax,NNC0480-0389,SD Maximum plasma concentration of NNC0480-0389 after a single dose	measured in nmol/L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Secondary	AUC0-8,sema,SD Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose	measured in hnmol^L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Secondary	Cmax,sema,SD The maximum plasma concentration of semaglutide after a single dose	measured in nmol^L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)