A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects

What Was Tested

The trial (phase 4) is built around Sincalide.

Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and approved for the treatment of type 2 diabetes mellitus.

It had 1 arm (groups): Albiglutide / Placebo or Placebo / Albiglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Between 18 and 65 years of age. Have venous access sufficient to allow for intravenous (IV) infusion and blood sampling as per protocol. Subject's body mass index (BMI) is \>=18 kilogram (kg)/meter(m)\^2 and \<=30 kg/m\^2. Capable of giving signed informed consent.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Sincalide group and the comparison group should start out alike.

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

As a double-blind Sincalide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-06-11 with completion listed for 2015-10-13.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect (time frame: Day 4 in each treatment period). Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF) (time frame: Day 4 in each treatment period). Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion (time frame: Day 4 in each treatment period).

It also tracked 6 secondary outcomes, for example Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Change From Baseline in Heart Rate, Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance, Change From Baseline in Electrocardiogram (ECG) Parameters, Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event and Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Sincalide in 20 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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