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

NCT05498610 | Completed Phase 1

• 2 other identifiers: NN9389-4774U1111-1264-4516
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• AUC0-∞,sema,SD Area under the semaglutide plasma concentration-time curve from time 0 to infinity after a single dose

  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

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

Study Arms (3)

1.7 mg NNC0408-0389 plus 0.5 mg semaglutide

EXPERIMENTAL

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; Drug: Semaglutide

8.6 mg NNC0480-0389 plus 0.5 mg semaglutide

EXPERIMENTAL

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; Drug: Semaglutide

30 mg NNC0480 0389 plus 0.5 mg semaglutide

EXPERIMENTAL

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; Drug: Semaglutide

Interventions

NNC0480 0389 DRUG

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

1.7 mg NNC0408-0389 plus 0.5 mg semaglutide; 30 mg NNC0480 0389 plus 0.5 mg semaglutide; 8.6 mg NNC0480-0389 plus 0.5 mg semaglutide

Semaglutide DRUG

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

1.7 mg NNC0408-0389 plus 0.5 mg semaglutide; 30 mg NNC0480 0389 plus 0.5 mg semaglutide; 8.6 mg NNC0480-0389 plus 0.5 mg semaglutide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: August 11, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)