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

NCT04878406 | Completed Phase 1

• 2 other identifiers: NN9389-4680U1111-1263-7182
• 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 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.

Conditions

Healthy Volunteers Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (6)

1.7 mg NNC0480-0389 + 0.5 mg Semaglutide

EXPERIMENTAL

Participants will be co-administered single doses of 1.7 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Drug: NNC0480-0389; Drug: Semaglutide

Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide)

PLACEBO COMPARATOR

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Drug: Placebo (NNC0480-0389); Drug: Placebo (Semaglutide)

8.6 mg NNC0480-0389 + 0.5 mg Semaglutide

EXPERIMENTAL

Participants will be co-administered single doses of 8.6 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Drug: NNC0480-0389; Drug: Semaglutide

Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)

PLACEBO COMPARATOR

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Drug: Placebo (NNC0480-0389); Drug: Placebo (Semaglutide)

30 mg NNC0480-0389 + 0.5 mg Semaglutide

EXPERIMENTAL

Participants will be co-administered single doses of 30 mg NNC0480-0389 and 0.5 mg semaglutide as separate injections.

Drug: NNC0480-0389; Drug: Semaglutide

Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)

PLACEBO COMPARATOR

Participants will be co-administered single doses of placebo (NNC0480-0389) and placebo (semaglutide) as separate injection.

Drug: Placebo (NNC0480-0389); Drug: Placebo (Semaglutide)

Interventions

NNC0480-0389 DRUG

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

1.7 mg NNC0480-0389 + 0.5 mg Semaglutide; 30 mg NNC0480-0389 + 0.5 mg Semaglutide; 8.6 mg NNC0480-0389 + 0.5 mg Semaglutide

Placebo (NNC0480-0389) DRUG

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

Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide); Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide); Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)

Semaglutide DRUG

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

1.7 mg NNC0480-0389 + 0.5 mg Semaglutide; 30 mg NNC0480-0389 + 0.5 mg Semaglutide; 8.6 mg NNC0480-0389 + 0.5 mg Semaglutide

Placebo (Semaglutide) DRUG

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

Placebo (1.7 mg NNC0480-03899) + placebo (0.5 mg Semaglutide); Placebo (30 mg NNC0480-0389) + placebo (0.5 mg Semaglutide); Placebo (8.6 mg NNC0480-0389) + placebo (0.5 mg Semaglutide)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Interventions

semaglutide

Study Officials

• Clinical Transparency (Dept.1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 7, 2021
• Study Start: May 18, 2021
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)