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Influence of Appetite Related Hormones in Binge Eating Behaviour Among the Overweight and Obese

Plain-language guide to NCT01739049: phase 4 randomized trial of Liraglutide, 42 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01739049
Phase
phase 4
Status
completed
Start
2012-11
Completion (planned or actual)
2013-10
Participants
42 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Binge Eating Behaviour
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

Binge eating is a symptom described in various eating disorders.

It had two arms (groups): Liraglutide and lifestyle counselling (experimental) and Lifestyle counselling (active comparator).

Diet and Exercise.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 42 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: Subjects who are willing to participate and sign informed consent form. Subjects who are able to answer the questionnaire. Subjects who are between 18-65 years old. Subjects with BMI 30-45. Subjects who are willing to administer injection.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: pregnant subjects; subjects on medication that may influence appetite, satiety and weight; subjects that plan to move out of state/country.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-11 with completion listed for 2013-10.

It ran at 1 site in Malaysia.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 42 people.

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

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

Our Notes on the Compound

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.