Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

NCT01515592 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and tolerability of the medication liraglutide in healthy Japanese men.

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

Timeline Started 2006-01 · est. completion 2006-04

Where 1 site · Japan

What this study is testing ClinicalTrials.gov NCT01515592 ↗

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 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.

Treatments tested

liraglutide Drug

One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg
liraglutide Drug

One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks
liraglutide Drug

One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks
placebo Drug

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

Main thing measured	Adverse events
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01515592 ↗