POSE2.0 With GLP-1 Agonist for Obesity Management

What Was Tested

The trial (not phased) is built around Liraglutide.

Determine the effect on weight loss and obesity-related comorbidities in patients receiving the POSE 2.0 procedure with sequential use of Liraglutide at 6 months compared to those receiving Liraglutide and then undergoing the POSE 2.0 procedure at 6 months.

It had two arms (groups): POSE2.0 Procedure (active comparator) and Liraglutide (active comparator).

The registry classes the interventions as device and drug.

More on the Plan

The growing impact of obesity worldwide has consequences on patients' quality of life, numerous weight-related comorbidities, and global economic costs.

Furthermore, it is often unavailable to those with class I or II obesity.

No studies have evaluated these therapies head-to-head and in combination.

This pilot randomized crossover trial aims to investigate the weight loss outcomes between Liraglutide and POSE2.0 procedure.

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to people of any sex aged from 22 years up to 60 years.

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

Examples of who could join: Participants will be adult patients (22 years of age or above and less than 60 years of age). Body mass index (BMI) ≥30 and \<40 kg/m2. Provision of signed and dated informed consent form. Subject agrees to be compliant with study requirements and adhere to dietary \& exercise recommendations for the duration of the study. If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum HCG at screening/baseline.

The full record lists 10 inclusion and 30 exclusion criteria; among the exclusions: prior bariatric, gastric or esophageal surgery; esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution; large hiatal hernia (\>3 cm) by history or as determined by pre-enrollment endoscopy.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2023-01-16 with completion listed for 2025-01-03.

It ran at 1 site in United Arab Emirates.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean percent total body weight loss at 6 months in each arm of the study (time frame: 6 months). Percentage of subjects with ≥5 percent total body weight loss at 6 months in each arm at 6 months (time frame: 6 months). The incidence, frequency, and severity of adverse events related to treatment with the device and procedure as well as medication will be reported (time frame: at 6 months).

It also tracked 5 secondary outcomes, for example Mean percent TBWL in each arm of the study at 12 months, Percentage of subjects with ≥10 percent TBWL at 6 months in each arm, Percentage of subjects with ≥10 percent TBWL at 12 months in each arm, Change from baseline of the Controlled Attenuation Parameter (CAP) dB/m measured by Fibroscan at 6 months in each arm and Change from baseline of the Controlled Attenuation Parameter (CAP) dB/m measured by Fibroscan at 12 months in each arm.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 50 people.

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

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