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

Sponsor
Novo Nordisk A/S
Study ID
NCT05498610
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Aug 11, 2022
Status verified
Dec 2023
Primary completion
Oct 12, 2022
Completion
Oct 12, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1.7 mg NNC0408-0389 plus 0.5 mg semaglutide
    Participants will receive a single subcutanous dose of 1.7 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections
  • Experimental: 8.6 mg NNC0480-0389 plus 0.5 mg semaglutide
    Participants will receive a single subcutanous dose of 8.6 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections
  • Experimental: 30 mg NNC0480 0389 plus 0.5 mg semaglutide
    Participants will receive a single subcutanous dose of 30 mg of NNC0408-0389 in combination with a fixed dose of 0.5 mg semaglutide administered as separate injections

Primary Outcome Measure

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) ]

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