Evaluation of Liraglutide [amount hidden] in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide for fat loss, obesity & body recomposition.

It had two arms (groups): Treatment (experimental) and Control (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The screening assessment will be undertaken only upon patients providing informed consent to undergo such procedure.

Information regarding medical history and concomitant medications will be gathered.

In addition, full physical examination, blood test and a meal test will be performed.

All female participants of childbearing potential will be tested for pregnancy.

Who Took Part

The registry lists 70 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Adults, 18-64 years inclusive. Fluent in English and able to understand and complete questionnaires. Willing and able to provide written informed consent and comply with the trial protocol.

The full record lists 8 inclusion and 20 exclusion criteria; among the exclusions: had a surgical procedure other than gastric bypass and sleeve gastrectomy; pregnant or lactating mothers; participation in other clinical intervention trial.

How the Study Was Run

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

The fat loss, obesity & body recomposition participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Neither the fat loss, obesity & body recomposition 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 2018-08-22 with completion listed for 2019-11-28.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: %WL (time frame: 24 weeks).

It also tracked 17 secondary outcomes, for example %fat, Skeletal muscle mass, Bone mineral density, Glucose level, Insulin and HbA1c.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 70 people with fat loss, obesity & body recomposition.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, Fat loss, obesity & body recomposition research.