ObesityNCT05705388
POSE2.0 With GLP-1 Agonist for Obesity Management
A study testing POSE2.0 Endoscopic Gastric Remodeling and Liraglutide injection in people with Obesity, run by Emirates Health Services (EHS) at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- POSE2.0 Endoscopic Gastric Remodeling and Liraglutide injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 16 Jan 2023to 3 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Ibrahim Bin Hamad Obaidullah Hospital
Ras al-Khaimah
Sana Al Qadi, +971 7 2465900, SanaHasan.AlQadi@ehs.gov.ae
About this study
Official title: 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
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.
Read the detailed description
The growing impact of obesity worldwide has consequences on patients' quality of life, numerous weight-related comorbidities, and global economic costs. Numerous therapies for obesity treatment involve lifestyle modifications, pharmacotherapy, and procedural intervention, though many limitations exist. Bariatric surgery has been shown to be the most durable and effective; however, the invasive nature and complications, such as micronutrient deficiencies, often damper enthusiasm for these procedures. Furthermore, it is often unavailable to those with class I or II obesity. Two emerging modalities have shown promising results for sustained weight loss: minimally invasive endoscopic bariatric therapies such as the POSE2.0 procedure and GLP-1 agonists, including Liraglutide. Recent data examining these methods individually have demonstrated weight loss of 5-10% percent total body weight for Liraglutide vs. 15-20% for POSE2.0. No studies have evaluated these therapies head-to-head and in combination. This pilot randomized crossover trial aims to investigate the weight loss outcomes between Liraglutide and POSE2.0 procedure. The investigators will recruit 25 subjects in each of the two intervention groups for a 6-month treatment period with each therapy. At 6 months, if the subject has not attained a BMI less than or equal to 30 kg/m2 in the Liraglutide arm or 28 kg/m2 in the POSE2.0 arm, they will cross over to the other intervention to utilize the combination of POSE2.0 and Liraglutide for additional 6 months. As per clinical guidelines, The cross-over criteria are congruent with accepted clinical guidelines for the use of these interventions. If the patient does not achieve greater than 5% total body weight loss on Lirglutide alone by 3 months as per accepted clinical criteria, the Liraglutide will not be continued as per clinical recommendation and the subject will cross over to the POSE2.0 procedure at 6 months.
- Conditions
- Obesity
- Being tested
- POSE2.0 Endoscopic Gastric Remodeling, Liraglutide injection
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSE2.0 Endoscopic Gastric RemodelingDevice
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 injectionDrug
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 group | Role | What they receive |
|---|---|---|
| POSE2.0 Procedure | Active comparator | 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. Receives: Device: POSE2.0 Endoscopic Gastric Remodeling; Drug: Liraglutide injection |
| Liraglutide | Active comparator | 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. Receives: Device: POSE2.0 Endoscopic Gastric Remodeling; Drug: Liraglutide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent total body weight loss at 6 months in each arm of the study
Percent total body weight loss
Measured: 6 months
Percentage of subjects with ≥5 percent total body weight loss at 6 months in each arm at 6 months
Percentage of subjects with ≥5 percent total body weight loss
Measured: 6 months
The incidence, frequency, and severity of adverse events related to treatment with the device and procedure as well as medication will be reported.
Adverse events
Measured: at 6 months
Secondary outcomes (5)
Mean percent TBWL in each arm of the study at 12 months.
Mean percent total body weight loss in each arm at 12 months.
Measured: 12 months
Percentage of subjects with ≥10 percent TBWL at 6 months in each arm.
Percentage of subjects with ≥10 percent TBWL at 6 months.
Measured: 6 months
Percentage of subjects with ≥10 percent TBWL at 12 months in each arm.
Percentage of subjects with ≥10 percent TBWL at 12 months in each arm.
Measured: 12 months
Change from baseline of the Controlled Attenuation Parameter (CAP) dB/m measured by Fibroscan at 6 months in each arm
Controlled Attenuation Parameter (CAP) each arm (dB/m)
Measured: 6 months
Change from baseline of the Controlled Attenuation Parameter (CAP) dB/m measured by Fibroscan at 12 months in each arm.
Controlled Attenuation Parameter (CAP) each arm (dB/m)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start16 Jan 2023
- Primary completion3 Jan 2025 (estimated)
- Study completion3 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 6 months of liraglutide (titrated to 3mg daily or maximal tolerated dose) or 6 months of POSE 2.0 with both groups receiving combination of both therapies for 6 months if they did not reach a BMI less than 30kg/m2 at the time of cross-over at 6 months.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emirates Health Services (EHS)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mariam Salem Alkhatry, Emirates Health Services (EHS)
- Investigators
- Maryam AlKhatry, MD, Principal investigator, EHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705388
- Sponsor's protocol ID
- UAE_V1
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05705388
- Acronym / sponsor ID
- UAE_V1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Emirates Health Services (EHS)Other government
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 3 Jan 2025 (estimated)
- Study completion
- 3 Jan 2026 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The growing impact of obesity worldwide has consequences on patients' quality of life, numerous weight-related comorbidities, and global economic costs. Numerous therapies for obesity treatment involve lifestyle modifications, pharmacotherapy, and procedural intervention, though many limitations exist. Bariatric surgery has been shown to be the most durable and effective; however, the invasive nature and complications, such as micronutrient deficiencies, often damper enthusiasm for these procedures. Furthermore, it is often unavailable to those with class I or II obesity. Two emerging modalities have shown promising results for sustained weight loss: minimally invasive endoscopic bariatric therapies such as the POSE2.0 procedure and GLP-1 agonists, including Liraglutide. Recent data examining these methods individually have demonstrated weight loss of 5-10% percent total body weight for Liraglutide vs. 15-20% for POSE2.0. No studies have evaluated these therapies head-to-head and in combination. This pilot randomized crossover trial aims to investigate the weight loss outcomes between Liraglutide and POSE2.0 procedure. The investigators will recruit 25 subjects in each of the two intervention groups for a 6-month treatment period with each therapy. At 6 months, if the subject has not attained a BMI less than or equal to 30 kg/m2 in the Liraglutide arm or 28 kg/m2 in the POSE2.0 arm, they will cross over to the other intervention to utilize the combination of POSE2.0 and Liraglutide for additional 6 months. As per clinical guidelines, The cross-over criteria are congruent with accepted clinical guidelines for the use of these interventions. If the patient does not achieve greater than 5% total body weight loss on Lirglutide alone by 3 months as per accepted clinical criteria, the Liraglutide will not be continued as per clinical recommendation and the subject will cross over to the POSE2.0 procedure at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 6 months of liraglutide (titrated to 3mg daily or maximal tolerated dose) or 6 months of POSE 2.0 with both groups receiving combination of both therapies for 6 months if they did not reach a BMI less than 30kg/m2 at the time of cross-over at 6 months.
| Arm | Type | Receives |
|---|---|---|
| POSE2.0 Procedure | Active comparator | Device: POSE2.0 Endoscopic Gastric Remodeling, Drug: Liraglutide injectionThe 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 | Active comparator | Device: POSE2.0 Endoscopic Gastric Remodeling, Drug: Liraglutide injectionLiraglutide 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. |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POSE2.0 Endoscopic Gastric RemodelingThe 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. | Device | Liraglutide, POSE2.0 Procedure |
| Liraglutide injectionLiraglutide 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. | Drug | Liraglutide, POSE2.0 Procedure |
Primary outcome
Mean percent total body weight loss at 6 months in each arm of the study
Time frame: 6 months
Percent total body weight loss
Percentage of subjects with ≥5 percent total body weight loss at 6 months in each arm at 6 months
Time frame: 6 months
Percentage of subjects with ≥5 percent total body weight loss
The incidence, frequency, and severity of adverse events related to treatment with the device and procedure as well as medication will be reported.
Time frame: at 6 months
Adverse events
5 secondary outcomes
Mean percent TBWL in each arm of the study at 12 months.
Time frame: 12 months
Percentage of subjects with ≥10 percent TBWL at 6 months in each arm.
Time frame: 6 months
Percentage of subjects with ≥10 percent TBWL at 12 months in each arm.
Time frame: 12 months
Change from baseline of the Controlled Attenuation Parameter (CAP) dB/m measured by Fibroscan at 6 months in each arm
Time frame: 6 months
Change from baseline of the Controlled Attenuation Parameter (CAP) dB/m measured by Fibroscan at 12 months in each arm.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam AlKhatry, MD principal investigator
EHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POSE2.0 Endoscopic Gastric Remodeling and Liraglutide injection in people with Obesity, run by Emirates Health Services (EHS) at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sana Al Qadi (+971 7 2465900, SanaHasan.AlQadi@ehs.gov.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent total body weight loss at 6 months in each arm of the study (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.