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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
NNC0480 0389
Semaglutide
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1.7 mg NNC0408-0389 plus 0.5 mg semaglutide

8.6 mg NNC0480-0389 plus 0.5 mg semaglutide

30 mg NNC0480 0389 plus 0.5 mg semaglutide

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
Cmax,NNC0480-0389,SD Maximum plasma concentration of NNC0480-0389 after a single dose
measured in nmol/L

Secondary Outcome Measures

AUC0-∞,sema,SD Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose
measured in hnmol^L
Cmax,sema,SD The maximum plasma concentration of semaglutide after a single dose
measured in nmol^L

Full Information

First Posted
August 9, 2022
Last Updated
December 19, 2022
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05498610
Brief Title
A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men
Official Title
Investigation of Pharmacokinetic Properties of Subcutaneously co Administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Chinese Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
October 12, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.7 mg NNC0408-0389 plus 0.5 mg semaglutide
Arm Type
Experimental
Arm Description
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
Arm Title
8.6 mg NNC0480-0389 plus 0.5 mg semaglutide
Arm Type
Experimental
Arm Description
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
Arm Title
30 mg NNC0480 0389 plus 0.5 mg semaglutide
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
NNC0480 0389
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
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
Primary Outcome Measure Information:
Title
AUC0-∞,NNC0480-0389,SD Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity after a single dose (SD)
Description
measured in hnmol^L
Time Frame
From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Title
Cmax,NNC0480-0389,SD Maximum plasma concentration of NNC0480-0389 after a single dose
Description
measured in nmol/L
Time Frame
From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Secondary Outcome Measure Information:
Title
AUC0-∞,sema,SD Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose
Description
measured in hnmol^L
Time Frame
From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Title
Cmax,sema,SD The maximum plasma concentration of semaglutide after a single dose
Description
measured in nmol^L
Time Frame
From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
IPD Sharing URL
http://novonordisk-trials.com

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

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