Combining POSE2.0 procedure with Liraglutide for weight loss in 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

This study is testing whether combining a new stomach procedure with a weight loss medication can help people with obesity lose more weight and improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 22 Years to 60 Years
• Sex: All
• Sponsor: Emirates Health Services (EHS) (Government)
• Drugs / interventions: prednisone
• Locations: 1 site (Ras al-Khaimah)
• Trial ID: NCT05705388 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of the POSE2.0 endoscopic gastric remodeling procedure combined with the GLP-1 agonist Liraglutide on weight loss and obesity-related comorbidities. Participants will be randomly assigned to receive either the POSE2.0 procedure followed by Liraglutide or vice versa over a 6-month period. The study aims to determine which approach yields better weight loss outcomes and to evaluate the potential benefits of combining these two therapies. A total of 50 subjects will be recruited for this pilot trial, with crossover options for those who do not achieve target BMI goals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 60 with a BMI between 30 and 40 kg/m2 who are committed to dietary and exercise recommendations.

Not a fit: Patients with severe systemic diseases or those who have undergone other weight loss procedures recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients struggling with obesity and its related health issues.

How similar studies have performed: While individual therapies have shown promise, this combined approach has not been previously evaluated, making it a novel investigation.

Eligibility 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

Where this trial is running

Ras al-Khaimah

• Ibrahim Bin Hamad Obaidullah Hospital — Ras al-Khaimah, United Arab Emirates (Recruiting)

Study contacts

• Principal investigator: Maryam AlKhatry, MD — Ehs
• Study coordinator: Sana Al Qadi

Conditions Obesity