Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide for fat loss, obesity & body recomposition.

It had two arms (groups): Liraglutide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The objective of this study was to compare effects of liraglutide and placebo over 16 weeks on gastric motor functions, satiation, satiety and weight in obese patients.

Subjects were randomized to liraglutide or placebo.

At baseline and after 16 weeks' treatment, the investigators measured weight, gastric emptying of solids (GES), gastric volumes, satiation (maximum tolerated volume of liquid nutrient drink), and satiety.

GES was also measured at 5 weeks.

Who Took Part

Enrollment: 40 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: Overweight and obese adults (≥30 kg/m\^2 or ≥27 kg/m\^2 with an obesity-related co-morbidity). Subjects must have the ability to provide informed consent before any trial-related activities.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes); abdominal surgery other than appendectomy, caesarian section or tubal ligation; patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia-type 2.

How the Study Was Run

It was run as a randomized, factorial and double-blind study.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

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 and investigator.

It started in 2015-12-18 with completion listed for 2016-12-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks (time frame: 5 weeks). Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks (time frame: 16 weeks).

It also tracked 8 secondary outcomes, for example Weight Change at 5 Weeks, Weight Change at 16 Weeks, Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks, Satiation Volume to Fullness at 16 Weeks, Satiation Maximum Tolerated Volume at 16 Weeks and Gastric Fasting Volume at 16 Weeks.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 40 people with fat loss, obesity & body recomposition.

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

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