Pilot Study of the Effect of Liraglutide [amount hidden] on Weight Loss and Gastric Functions in Obesity

What Was Tested

This registered phase 2 trial tested Liraglutide for fat loss, obesity & body recomposition.

Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.

It had two arms (groups): Liraglutide (experimental) and Placebo (experimental).

The registry classes the interventions as drug.

Who Took Part

136 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 residing within 125 miles of Mayo Clinic in Rochester, Minnesota. The investigators plan to recruit equal proportions of men and women. Subjects must have the ability to provide informed consent before any trial-related activities.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes); abdominal surgery other than appendectomy, cholecystectomy, 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.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2017-11-29 with completion listed for 2021-08-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 8 secondary outcomes, for example Change in Weight at 5 Weeks, Change in Weight at 16 Weeks, Satiety, Satiation Volume to Fullness, Maximum Satiation and Fasting Gastric Volume Prior to Meal.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 136 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.