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

What Was Tested

The trial (phase 1) is built around Liraglutide.

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions.

Safety profile and immunogenicity data were collected from each subject.

It had two arms (groups): Liraglutide injection (experimental) and Liraglutide injection(Victoza®) (active comparator).

The registry classes the interventions as drug.

More on the Plan

Following 7 days washout period, all subjects received the alternate formulation during the second period.

Who Took Part

32 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male vulunteers aged 18 and above. The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment; participation in another clinical trial within 3 months; smoking more than 5 cigarettes per day during the 3 months prior to screening.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-07-16 with completion listed for 2021-07-30.

It ran at 1 site in China.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Peak Plasma Concentration (Cmax) (time frame: 40 days). Area under the plasma concentration versus time curve (AUC)0-t (time frame: 40 days). Area under the plasma concentration versus time curve (AUC)0-∞ (time frame: 40 days).

It also tracked 1 secondary outcome, for example Incidence of Treatment-Emergent Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 32 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.