GLP-1 Peptide Atlas, by Delfa

UnknownPhase NA

POSE2.0 With GLP-1 Agonist for 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

Lead sponsor

Emirates Health Services (EHS)

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-40

Primary endpoints

•Body weight, % change•≥5% weight-loss responders•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05705388

Org study IDUAE_V1

Timeline

Milestones

Study start2023-01-16actual

Study first posted2023-01-30actual

Last update posted2023-01-30actual

Primary completion2025-01-03estimated

Study completion2026-01-03estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age22 Years

Maximum age60 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

MASH / liver

Safety / tolerability / PK

Weight & body composition

5 endpoints

Primary/protocol endpoint

Mean percent total body weight loss at 6 months in each arm of the study

Time frame:6 months

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of subjects with ≥5 percent total body weight loss at 6 months in each arm at 6 months

Time frame:6 months

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Mean percent TBWL in each arm of the study at 12 months.

Time frame:12 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of subjects with ≥10 percent TBWL at 6 months in each arm.

Time frame:6 months

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of subjects with ≥10 percent TBWL at 12 months in each arm.

Time frame:12 months

≥10% weight-loss responders

threshold achievement, improvement

MASH / liver

3 endpoints

Secondary/protocol endpoint

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, improvement

Secondary/protocol endpoint

Change from baseline of the Controlled Attenuation Parameter (CAP) dB/m measured by Fibroscan at 12 months in each arm.

Time frame:12 months

change from baseline, improvement

Other/protocol endpoint

Change from baseline of liver fibrosis score (kilopascal) measured by Fibroscan at 12 months.

Time frame:12 months

Liver stiffness (VCTE), change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

Treatment-emergent AEs (any)

descriptive, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.