A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects

NCT05225974 · Completed

Last updated 2026-05-28

This clinical trial tested the safety and how the body processes Liralutide injection in healthy Chinese adults.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) study

Participants 32 people

Who can join Ages 18+ · male only Healthy volunteers accepted.

Timeline Started 2021-07 · est. completion 2021-08

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT05225974 ↗

Description as written by the study sponsor.

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.

Treatments tested

Liraglutide injection Drug

At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection
Liraglutide injection(Victoza®) Drug

At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection

Main thing measured	Peak Plasma Concentration (Cmax)
Sponsor	The Affiliated Hospital of Qingdao University
Conditions studied	Therapeutic Equivalency
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05225974 ↗