A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Liraglutide.

It had two arms (groups): Liraglutide injection (RD12014)+ Victoza (experimental) and Victoza + Liraglutide injection (RD12014) (experimental).

Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.

Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: 2\. Aged between 18 and 45 years old of healthy male subjects ;. 3\. Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;. 4\. No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: 1\. have a history of fainting needles, fainting blood;; 2\. positive for hepatitis (including hepatitis b and c), hiv or syphilis at screening;; 4\. have a history of taken liraglutide or other human glucagon-like peptides-1 analogues before the trial;.

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.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2020-06-22 with completion listed for 2020-07-20.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximum (peak) plasma drug concentration(Cmax). Area under the plasma concentration-time curve from time zero to time t (AUC0-t).

It also tracked 6 secondary outcomes, for example Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞), Time to reach maximum plasma concentration following drug administration (Tmax), Elimination half-life (t1/2), Apparent total body clearance (CL/F), Apparent volume of distribution (Vd/F) and Adverse Event, Serious Adverse Event.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 50 people.

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.