POSE2.0 With GLP-1 Agonist for Obesity Management

Inclusion Criteria:

• Participants will be adult patients (22 years of age or above and less than 60 yearsof 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 birthcontrol during year of study and have negative serum HCG at screening/baseline.
• Absence of current severe systemic disease (including, but not limited to: coronaryartery disease, chronic obstructive pulmonary disease, congestive heart failure,cancer, and chronic renal disease).
• Agrees not to undergo any additional weight loss interventional procedures orliposuction for 12 months following study enrollment.
• Have not taken any prescription or over the counterweight loss medications OR thosethat can suppress appetite/induce weight loss for at least 6 months and agrees not toutilize 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 (~50miles) and willing and able to travel to the Investigator's office to complete allroutine follow-up visits

Exclusion Criteria:

• Prior bariatric, gastric or esophageal surgery.
• Esophageal stricture or other anatomy and/or condition that could preclude passage ofendoluminal instruments or procedure execution.
• Moderate gastro-esophageal reflux disease (GERD), defined as symptoms that causesubject severe discomfort, compromise performance of daily activities, and/orcondition 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 orgeneralized dysmotility (e.g. esophago-gastric motility issues and lower esophagealsphincter 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 6months of Visit 1. Intranasal/inhaled steroids are acceptable.
• Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatorydrugs (NSAIDs), or other medications known to be gastric irritants beginning two weeksprior to enrollment and throughout the entire study.
• History of inflammatory disease of the GI tract; coagulation disorders; hepaticinsufficiency 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 atthe 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 ofabuse. - Patient is currently using marijuana/cannabis for either medicinal orrecreational use, or has plans to start using over the next 12 months.
• Present or history of psychosis, bipolar disease, or obsessive-compulsive disorderafter 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, thepsychologist(s) assigned to the study will be contacted and arrangement will be madefor immediate intervention according to the Institution's standard procedure.
• Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30minutes).
• 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 includinghypersensitivity to the drugs or materials that will be utilized in the studyprocedure.
• 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