Clinical trial NCT04878406: A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men
Official title: Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of dosing (day 1) until completion of the follow-up visit (day 43)
Secondary outcomes:
measure: AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose
timeFrame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
measure: Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose
timeFrame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
measure: AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose
timeFrame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
measure: Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose
timeFrame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (Dept.1452)
role: STUDY_DIRECTOR
References: