POSE2.0 With GLP-1 Agonist for Obesity Management

NCT05705388 | Unknown FDA Device

• 1 other identifier: UAE_V1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

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

  Percent total body weight loss

  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

  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

  at 6 months

Secondary Outcomes (5)

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

  12 months

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

  6 months

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

  12 months

• Change from baseline of the Controlled Attenuation Parameter (CAP) dB/m measured by Fibroscan at 6 months in each arm

  6 months

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

  12 months

Other Outcomes (1)

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

  12 months

Study Arms (2)

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.

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.

Device: POSE2.0 Endoscopic Gastric Remodeling; Drug: Liraglutide injection

Interventions

POSE2.0 Endoscopic Gastric Remodeling DEVICE

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; POSE2.0 Procedure

Liraglutide injection DRUG

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.

Liraglutide; POSE2.0 Procedure

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emirates Health Services (EHS): lead

Study Sites (1)

Ibrahim Bin Hamad Obaidullah Hospital

Ras al-Khaimah, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Maryam AlKhatry, MD

  EHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sana Al Qadi

CONTACT

+971 7 2465900; SanaHasan.AlQadi@ehs.gov.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopy, Division of Gastroenterology, Ibrahim Bin Hamad Obaidullah Hospital, Ras Al Khaimah, United Arab Emirates

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 30, 2023
• Study Start: January 16, 2023
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2026
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)