Binge Eating Liraglutide Intervention

What Was Tested

This registered phase 3 trial tested Liraglutide.

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

The registry classes the interventions as drug.

More on the Plan

All applicants will be initially screened by phone and/or electronically to determine whether they potentially meet eligibility criteria.

Those who appear to meet eligibility criteria and remain interested in the trial will be scheduled for an in-person interview.

Subjects who remain interested and pass this portion of the assessment will proceed to meet with the study physician or nurse practitioner, who will obtain a medical history and conduct a physical examination to determine medical eligibility.

Subjects will also have an electrocardiogram (EKG), fasting blood test, and a urine pregnancy test (for females of child bearing age) to confirm eligibility.

Who Took Part

36 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

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

Examples of who could join: Age ≥ 21 years and ≤ 70 years. Meet full DSM 5 criteria for BED. These episodes feature at least 3 of the following:. All races and ethnicities are included. Eligible female subjects will be:.

The full record lists 16 inclusion and 24 exclusion criteria; among the exclusions: pregnant or nursing, or plans to become pregnant in the next 6 months, or not using adequate contraceptive measures; personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2; uncontrolled hypertension (systolic blood pressure ≥ 160 mm hg or diastolic blood pressure ≥ 100 mm hg).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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

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

It started in 2017-09-29 with completion listed for 2019-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Binge Episodes (time frame: baseline and 17 weeks (or last observation carried forward)).

It also tracked 3 secondary outcomes, for example Remission From Binge-eating and Change in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 36 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.