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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers Type 2 Diabetes
• Intervention / Treatment: Drug: NNC0480-0389; Drug: Semaglutide; Drug: Placebo (NNC0480-0389); Drug: Placebo (Semaglutide)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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/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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment emergent adverse events (TEAEs)	Count of events	From time of dosing (day 1) until completion of the follow-up visit (day 43)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose	Measured in nmol/L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
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	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose	Measured in nmol/L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NN9389-4680; U1111-1263-7182 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No