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

NCT04878406 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-17

No results posted yet for this study

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

Interventions

DRUG

NNC0480-0389

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

DRUG

Placebo (NNC0480-0389)

A single dose of subcutaneous placebo (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.

DRUG

Placebo (Semaglutide)

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (Dept.1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2021-07-20
Completion
2021-07-20

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878406 on ClinicalTrials.gov