Impact of Liraglutide 3.0 on Body Fat Distribution

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Obesity has long been recognized as a risk factor for all-cause mortality and morbidity, including the development of cardiovascular and metabolic diseases such as coronary artery disease, hypertension, insulin resistance, diabetes, and dyslipidemia.

As a result, BMI alone is an insufficient marker of risk and may not accurately identify individuals at elevated risk for ASCVD.

Who Took Part

The registry lists 235 actual participants took part.

It was open to people of any sex aged from 35 years with no upper age limit.

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

Examples of who could join: Age ≥ 35 years. Able to provide informed consent. BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with metabolic syndrome. Metabolic syndrome is defined as at least three of the following:3. Waist circumference \> 102 cm (40 in) in men and 88 cm (35 in) in women.

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial; history of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes medication; history of chronic pancreatitis or idiopathic acute pancreatitis (current or prior history).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

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

It started in 2017-01 with completion listed for 2020-10-13.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 35 secondary outcomes, for example Change From Baseline in VAT/SAT Ratio, Change From Baseline in Total Fat/Fat-free Mass Ratio, Relative Percent Change in Fasting Blood Glucose, Relative Percent Change in Insulin, Relative Percent Change in HOMA-IR and Relative Percent Change in C-reactive Protein.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 235 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.