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Healthy Volunteers Type 2 DiabetesPhase 1NCT04878406

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

A Phase 1 study testing NNC0480-0389 and Semaglutide in people with Healthy Volunteers Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers Type 2 Diabetes
What is being tested?
NNC0480-0389 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteJapan
Study dates
18 May 2021to 20 Jul 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Novo Nordisk Investigational Site

    Fukuoka, 812-0025

Other trials in Japan

About this study

Official title: Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects

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.

Being tested
NNC0480-0389, Placebo (NNC0480-0389), Semaglutide, Placebo (Semaglutide)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0480-0389Drug

    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.

  • SemaglutideDrug

    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 groups in NCT04878406
Study groupRoleWhat they receive
1.7 mg NNC0480-0389 + 0.5 mg SemaglutideExperimentalParticipants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
Receives: Drug: NNC0480-0389; Drug: Semaglutide
Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide)Placebo comparatorParticipants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
Receives: Drug: Placebo (NNC0480-0389); Drug: Placebo (Semaglutide)
8.6 mg NNC0480-0389 + 0.5 mg SemaglutideExperimentalParticipants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
Receives: Drug: NNC0480-0389; Drug: Semaglutide
Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)Placebo comparatorParticipants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
Receives: Drug: Placebo (NNC0480-0389); Drug: Placebo (Semaglutide)
30 mg NNC0480-0389 + 0.5 mg SemaglutideExperimentalParticipants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.
Receives: Drug: NNC0480-0389; Drug: Semaglutide
Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)Placebo comparatorParticipants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.
Receives: Drug: Placebo (NNC0480-0389); Drug: Placebo (Semaglutide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment emergent adverse events (TEAEs)

    Count of events

    Measured: From time of dosing (day 1) until completion of the follow-up visit (day 43)

Secondary outcomes (4)

  1. AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose

    Measured in nmol*h/L

    Measured: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

  2. Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose

    Measured in nmol/L

    Measured: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

  3. AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose

    Measured in nmol*h/L

    Measured: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

  4. Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose

    Measured in nmol/L

    Measured: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start18 May 2021
  3. Primary completion20 Jul 2021
  4. Study completion20 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878406
Sponsor's protocol ID
NN9389-4680
Other IDs
U1111-1263-7182
Status last verified
May 2023
First submitted
5 May 2021
Last updated
17 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0480-0389 and Semaglutide in people with Healthy Volunteers Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.

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