Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

NCT01620476 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and tolerability of the drug liraglutide in healthy Japanese volunteers.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 24 people

Who can join Ages 20–45 · male only Healthy volunteers accepted.

Timeline Started 2003-09 · est. completion 2004-03

Where 1 site · Japan

What this study is testing ClinicalTrials.gov NCT01620476 ↗

Description as written by the study sponsor.

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of liraglutide in healthy Japanese male subjects.

liraglutide Drug

5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
liraglutide Drug

5 mcg/kg for 7 days followed by 10 mcg/kg for 14 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
liraglutide Drug

5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days followed by 15 mcg/kg for 7 days. Injected subcutaneously once daily
placebo Drug

Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Main thing measured	Area under the plasma liraglutide curve
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Healthy
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01620476 ↗