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POSE2.0 With GLP-1 Agonist for Obesity Management

NCT05705388 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-01-30

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Emirates Health Services (EHS)

    lead OTHER_GOV

Principal Investigators

  • Maryam AlKhatry, MD · EHS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2025-01-03
Completion
2026-01-03
FDA Device
Yes

Countries

  • United Arab Emirates

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705388 on ClinicalTrials.gov