Cardiovascular Effects of GLP-1 Receptor Activation

What Was Tested

The trial (phase 4) is built around Liraglutide.

It had three arms (groups): liraglutide (experimental), sitagliptin (active comparator) and hypocaloric diet (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

329 actual participants took part.

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

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

Examples of who could join: Men and women,. Age 18 to 65 years, and. The ability to provide informed consent before any trial-related activities.

The full record lists 5 inclusion and 27 exclusion criteria; among the exclusions: resistant hypertension, defined as hypertension requiring the administration of more than three anti-hypertensive agents including a diuretic to achieve control; use of spironolactone; known or suspected allergy to trial medications, excipients, or related products.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Liraglutide 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 2017-05-01 with completion listed for 2021-06-24.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change in Flow-mediated Dilation (time frame: Baseline to 2 and 14 weeks). Urine Albumin-to-creatinine Ratio (time frame: Baseline to 13 weeks). Change in Plasminogen Activator Inhibitor-1 (time frame: Baseline to 2 and 14 weeks).

It also tracked 4 secondary outcomes, for example Blood Pressure, Fasting Glucose and Fasting Insulin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 329 people.

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

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