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

Conditions

• Healthy Volunteers Type 2 Diabetes

Eligibility Criteria

Sex

MALE

Age

20 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

May 18, 2021

Status verified

May 2023

Primary completion

Jul 20, 2021

Completion

Jul 20, 2021

Study Design

Enrollment

24 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1.7 mg NNC0480-0389 + 0.5 mg Semaglutide
  Participants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
• Placebo Comparator: Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide)
  Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
• Experimental: 8.6 mg NNC0480-0389 + 0.5 mg Semaglutide
  Participants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
• Placebo Comparator: Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)
  Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
• Experimental: 30 mg NNC0480-0389 + 0.5 mg Semaglutide
  Participants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
• Placebo Comparator: Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)
  Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Primary Outcome Measure

Number of treatment emergent adverse events (TEAEs) [ Time Frame: From time of dosing (day 1) until completion of the follow-up visit (day 43) ]