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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT04878406
Collaborator
(none)
24
1
6
2.1
11.6

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose:
Treatment
Official Title:
Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects
Actual Study Start Date :
May 18, 2021
Actual Primary Completion Date :
Jul 20, 2021
Actual Study Completion Date :
Jul 20, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: NNC0480-0389
A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.

Drug: Semaglutide
A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.

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.

Drug: Placebo (NNC0480-0389)
A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.

Drug: Placebo (Semaglutide)
A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

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.

Drug: NNC0480-0389
A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.

Drug: Semaglutide
A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.

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.

Drug: Placebo (NNC0480-0389)
A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.

Drug: Placebo (Semaglutide)
A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

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.

Drug: NNC0480-0389
A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.

Drug: Semaglutide
A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.

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.

Drug: Placebo (NNC0480-0389)
A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.

Drug: Placebo (Semaglutide)
A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.

Outcome Measures

Primary Outcome Measures

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

    Count of events

Secondary Outcome Measures

  1. AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose [From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)]

    Measured in nmol*h/L

  2. Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose [From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)]

    Measured in nmol/L

  3. AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose [From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)]

    Measured in nmol*h/L

  4. Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose [From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)]

    Measured in nmol/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Fukuoka Japan 812-0025

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (Dept.1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04878406
Other Study ID Numbers:
  • NN9389-4680
  • U1111-1263-7182
First Posted:
May 7, 2021
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 14, 2021