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Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections Versus Glucagon Like Peptide 1 Receptor Agonist in Weight Loss

Plain-language guide to NCT05268627: not phased randomized trial of Liraglutide, fat loss, obesity & body recomposition, 38 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05268627
Phase
not phased
Status
status unknown
Start
2022-01-27
Completion (planned or actual)
2023-01-27
Participants
38 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Liraglutide for fat loss, obesity & body recomposition.

Background: Obesity is an important public health concern.

It had two arms (groups): Endoscopic Ultrasound Guided Gastric Botulinum Toxin Injections (active comparator) and liraglutide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Introduction Obesity is an important public health concern.

Depth of injection in the gastric wall was largely unknown in these studies, as endoscopic ultrasound (EUS) was not used to guide injection into the muscularis propria or subserosal layers.

In a study by Topazian.

Also EUS guidance would help to assure injection of BTA in the gastric muscularis propria and subserosal layers of the gastric wall.

Who Took Part

38 planned participants were the target.

It was open to people of any sex aged from 20 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

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

The fat loss, obesity & body recomposition participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2022-01-27 with completion listed for 2023-01-27.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: weight loss (time frame: 1 year). Body mass index (time frame: 1 year). waist circumference (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 38 people with fat loss, obesity & body recomposition.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

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.