Effect and Safety of Liraglutide [amount hidden] as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted in the United States of America (USA).

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

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 282 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. BMI above or equal to 30 kg/m\^2. Male or female, age 18 years or older at the time of signing informed consent.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: personal or family history of medullary thyroid carcinoma (mtc), or multiple endocrine neoplasia type 2 (men2); history of pancreatitis (acute or chronic); history of major depressive disorder within the past 2 years.

How the Study Was Run

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

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.

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 and investigator.

It started in 2017-02-06 with completion listed for 2018-05-23.

It ran at 10 sites in United States (10).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Body Weight (%) (time frame: Week 0, week 56).

It also tracked 49 secondary outcomes, for example Change in Waist Circumference (cm), Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score, Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score, Change in Six Minutes Walking Distance Test (6MWT), Change From Baseline in HbA1c (%) and Change From Baseline in FPG (mg/dL).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 282 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.