A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men
NCT ID: NCT05498610
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2022-08-11
2022-10-12
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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U1111-1264-4516
Identifier Type: OTHER
Identifier Source: secondary_id
NN9389-4774
Identifier Type: -
Identifier Source: org_study_id