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

Investigation of Pharmacokinetic Properties of Subcutaneously co Administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Chinese Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: NNC0480 0389; Drug: Semaglutide

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

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Chinese male participants aged 18-55 years (both inclusive) at the time of signing informed consent.
• 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:

• Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: 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; Drug: 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
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	Drug: 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; Drug: 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
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	Drug: 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; Drug: 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

What is the study measuring?

Primary 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 after a single dose (SD)	measured in hnmol^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 after a single dose	measured in nmol/L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-∞,sema,SD Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose	measured in hnmol^L	From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Cmax,sema,SD The maximum plasma concentration of semaglutide after 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. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9389-4774; U1111-1264-4516 (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