POSE2.0 With GLP-1 Agonist for Obesity Management

Sponsor
Emirates Health Services (EHS)
Study ID
NCT05705388
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • POSE2.0 Endoscopic Gastric Remodeling — DEVICE
    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.
  • Liraglutide injection — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 16, 2023
Status verified
Jan 2023
Primary completion
Jan 3, 2025
Completion
Jan 3, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: POSE2.0 Procedure
    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.
  • Active Comparator: Liraglutide
    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.

Primary Outcome Measure

Mean percent total body weight loss at 6 months in each arm of the study [ Time Frame: 6 months ]

Central Contacts

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