NCT05705388

POSE2.0 With GLP-1 Agonist for Obesity Management

Comparison of Efficacy and Safety of POSE 2.0 Procedure Compared to GLP-1 Agonist in a Cohort of Patients for Management of Obesity: a Single-center Randomized Crossover-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Emirates Health Services (EHS) · Other Government
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The growing impact of obesity worldwide has consequences on patients' quality of life, numerous weight-related comorbidities, and global economic costs. Numerous therapies for obesity treatment involve lifestyle modifications, pharmacotherapy, and procedural intervention, though many limitations exist. Bariatric surgery has been shown to be the most durable and effective; however, the invasive nature and complications, such as micronutrient deficiencies, often damper enthusiasm for these procedures. Furthermore, it is often unavailable to those with class I or II obesity. Two emerging modalities have shown promising results for sustained weight loss: minimally invasive endoscopic bariatric therapies such as the POSE2.0 procedure and GLP-1 agonists, including Liraglutide. Recent data examining these methods individually have demonstrated weight loss of 5-10% percent total body weight for Liraglutide vs. 15-20% for POSE2.0. 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. The investigators will recruit 25 subjects in each of the two intervention groups for a 6-month treatment period with each therapy. At 6 months, if the subject has not attained a BMI less than or equal to 30 kg/m2 in the Liraglutide arm or 28 kg/m2 in the POSE2.0 arm, they will cross over to the other intervention to utilize the combination of POSE2.0 and Liraglutide for additional 6 months. As per clinical guidelines, The cross-over criteria are congruent with accepted clinical guidelines for the use of these interventions. If the patient does not achieve greater than 5% total body weight loss on Lirglutide alone by 3 months as per accepted clinical criteria, the Liraglutide will not be continued as per clinical recommendation and the subject will cross over to the POSE2.0 procedure at 6 months.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	POSE2.0 Endoscopic Gastric Remodeling	The POSE2.0 is a per-oral endoscopic gastroplasty procedure performed by the USGI Medical Incisionless Operating Platform (USGI Medical, San Clemente, CA) to deploy preloaded snowshoe suture anchors, and cinch create gastric endoscopic plications. In the POSE2.0 procedure a series of 15-20 pairs of snowshoes anchors are deployed along the greater curvature of the stomach from the proximal antrum to the proximal gastric body along narrowing the anteroposterior diameter of the stomach and decreasing its vertical length to improve satiety and satiation for weight loss. This device is registered and approved for obesity management in the United Arab Emirates, where the study is performed.
DRUG	Liraglutide injection	Liraglutide is a GLP-1 agonists approved for the management of obesity. In the study, it will be Initiated at 0.6 mg subcutaneously daily for 1 week; increase by 0.6 mg/day in weekly intervals until a dose of 3 mg/day achieved. If patients do not tolerate an increased dose during dose escalation, dose escalation will be delayed for an additional week. The patient will continue at the maximal tolerated does up to 3mg per day. If the patient has not lost at least 4% of baseline body weight at 16 weeks from medication initiation, the medication will be discontinued.

Timeline

• Start date: 2023-01-16
• Primary completion: 2025-01-03
• Completion: 2026-01-03
• First posted: 2023-01-30
• Last updated: 2023-01-30

Locations

1 site across 1 country: United Arab Emirates

Regulatory

• FDA-regulated device study