A research study of how the medicine NNC0480-0389 taken with semaglutide works in the body of healthy Japanese men

JRCT ID: jRCT2071210021

Registered date:11/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 18/05/2021
• Target sample size: 24
• Study type: Interventional

Intervention(s)

Single dose of subcutaneous NNC0480-0389 (1.7 mg, 8.6 mg or 30 mg) and semaglutide (0.5 mg only) or a single dose of subcutaneous NNC0480-0389 placebo and semaglutide placebo as separate injections
Screening visit, in-house treatment (5 nights) and follow-up visit
Follow-up period afrer dosing is 42 days.
Trial duration is 45 - 72 days for each subject (depending on time of screening relative to dosing)

Outcome(s)

• Primary Outcome: Number of treatment emergent adverse events

Secondary Outcome

- Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose
- Maximum plasma concentration of NNC0480-0389 upon a single-dose
- Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose
- Maximum plasma concentration of semaglutide upon a single-dose

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Male

Include 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/m2 and 24.9 kg/m2 (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.

Exclude criteria

-Any disorder which in the investigators opinion might jeopardise subjects safety or compliance with the protocol.
- HbA1c >= 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.

Related Information

• Primary Sponsor: Hashida Masahiro
• Secondary ID(s): NCT04878406