Comparison of Three Liraglutide Formulations in Healthy Volunteers

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Oceania.

The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7.

It had three arms (groups): pH 7.7 (experimental), pH 7.9 (experimental) and pH 8.15 (experimental).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments. Body Mass Index (BMI) of 18-27 kg/m\^2, both inclusive.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders; that may interfere with the objectives of the study, as judged by the investigator; family or personal history of primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia.

How the Study Was Run

Design: randomized, crossover and double-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2005-01-13 with completion listed for 2005-03-30.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the Curve (0-t). Cmax, maximum concentration.

It also tracked 5 secondary outcomes, for example Area under the curve (0-infinity), tmax, time to reach Cmax, t½, terminal half-life, Terminal elimination rate constant and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 24 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.