POSE2.0 With GLP-1 Agonist for Obesity Management

• Status: Recruiting
• Trial end date: 2026-01-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emirates Health Services (EHS)
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• 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.

• Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).

• Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.

• Have not taken any prescription or over the counterweight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).

• Subjects must be willing to possibly forego any future weight loss procedures (i.e. Vertical Sleeve Gastrectomy) following the study given the unknown long-term effects.

• Residing within a reasonable distance from the Investigator's treating office (~50 miles) and willing and able to travel to the Investigator's office to complete all routine follow-up visits

Exclusion Criteria:

• Prior bariatric, gastric or esophageal surgery.

• Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments or procedure execution.

• Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with drug therapy.

• Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.

• Pancreatic insufficiency/disease.

• History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g. esophago-gastric motility issues and lower esophageal sphincter abnormalities).

• Pregnancy or plans of pregnancy in the next 12 months.

• History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.

• Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit 1. Intranasal/inhaled steroids are acceptable.

• Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.

• History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis.

• Active gastric erosion, lesion, or gastric/duodenal ulcer.

• History of or current platelet or coagulation dysfunction, such as hemophilia.

• History or present use of insulin or insulin derivatives for treatment of diabetes.

• Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment.

• If smoker, plans to quit smoking in the year after enrollment.

• Portal hypertension and/or varices.

• Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse. - Patient is currently using marijuana/cannabis for either medicinal or recreational use, or has plans to start using over the next 12 months.

• Present or history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.

• Uncontrolled depression after pre-enrollment psychological and medical assessment.

• If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution's standard procedure.

• Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).

• Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).

• Participating in another clinical study.

• Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.

• Physician's assessment that the subject is not an appropriate candidate.

• Breastfeeding

• Personal or family history of medullary thyroid cancer or MEN2

• Suicidal ideation and behavior.

• Injection site reaction