The Effect of Extended Use of the EPITOMEE CAPSULE

Study Overview
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Brief Summary
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The Effect of Extended Use of the Epitomee Capsule on BodyWeight in subjects with Overweight and Obesity with and without Prediabetes

Detailed Description
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This is an interventional, open label, single arm extension study to assess the long-term safety and efficacy of the Epitomee Capsule in subjects who completed a 24-week treatment period with the Epitomee-Capsule and experienced at least 3% weight loss during that period. All participating subjects will receive the Epitomee capsule arm in combination with lifestyle intervention.

Official Title
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The Effect of Extended Use of the Epitomee Capsule on Body Weight in Subjects With Overweight and Obesity With and Without Prediabetes

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Device: Epitomee Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signing an informed consent form prior to any study activity Completed 24 weeks of the core study with maximum of two unattended visits Had at least 3% weight loss in week 24 visit of the core study Non-pregnant, evidenced by a negative urine dipstick pregnancy test by visit 24 week of the core study Females will be either surgically sterile or postmenopausal or agree to continue using an accepted method of birth control during the study Subjects with prediabetes could be untreated or treated with a stable dose of metformin up to 2000 mg/dL inclusive, for at least 1 month prior to entry into the study Currently not using and willingness to avoid non-steroidal anti-inflammatory drugs (NSAIDs) including Diclofenac, Ibuprofen, Naproxen excluding the use of low dose aspirin (75-100 mg) or Celebrex 200-400 mg. Able and willing to continue the lifestyle intervention program as required in the core study including diet and physical activity Subjects must have a primary care physician (PCP) who is responsible for providing routine care Subjects must have cellphone and internet service to communicate with study staff Study subjects must be willing to notify the staff of any change in their medical health (including surgeries) or change in drug treatments (addition of drugs, stopping of drugs, or change in drug dose) during the course of the study Subjects must be willing to avoid medications or other substances known to affect weight changes during the study Subjects on psychiatric medications are clinically well-controlled with a stable psychiatric medication dose for 3 months prior to entry into the extension study Exclusion Criteria: Currently receiving chronic steroid or immunosuppressive therapy Intending to undergo gastric surgery or gastric banding during the study period. Currently suffering from structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including: Barrett's esophagus, esophagus motility disorder, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, esophageal motility disorder, esophageal chest pain disorders or any other disorder of the esophagus Currently suffering from swallowing disorder, or drug refractory esophageal reflux symptoms Currently suffering from structural or functional disorders of the stomach including, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach or any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety. Currently suffering from duodenal ulcer, small bowel diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal (GI) tract Currently having ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting Currently having irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease Subjects with Fasting Plasma Glucose ≥126 mg/dL or HbA1c ≥ 6.5% based on blood test results at 24 week visit of the core study Any medications known to be gastric irritants for 4 weeks prior to study start Subjects with congestive heart failure (New York Heart Association (NYHA) Class II, III or IV; myocardial infarction (MI) and/or revascularization (e.g. coronary bypass graft/stent) within 12 months of study start Currently having poorly controlled hypertension (≥ 160 mmHg systolic or ≥ 100 mmHg diastolic) Subjects for whom any anti-platelet drugs beside low dose of Aspirin, have been initiated within 6 months prior to study start Subjects for whom any medications for hypertension or hyperlipidemia have been initiated within 1 month prior to study start Subjects for whom any anti-seizure or anti-arrhythmic medications have been initiated within 6 months prior to study start Subjects who are habitual laxative users or using prescription medication for chronic constipation Any other condition that, in the opinion of the investigator, would interfere with subject participation, may confound the study results, or interfere with compliance with the study (e.g., psychosocial issues, renal disease, hepatic disease, pulmonary disease or cancer disease). Subjects presenting poor abilities and inconsistencies in using the study app during the core study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epitomee Capsule<br>Epitomee Capsule combined with lifestyle counseling | Device: Epitomee Capsule<br>* Epitomee Capsule combined with lifestyle counseling.<br>* Other names: The MODEL IBT Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule | Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule during the course of the study | 24 weeks | 
| Change in percent weight loss | Change in percent weight loss between baseline weight of the Epitomee core study and week 24 of the extension study | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall incidence, causality and severity of adverse events, potentially related to Epitomee capsule. | Overall incidence, causality and severity of adverse events, potentially related to Epitomee capsule during the course of the study | 24 weeks | 
| Proportion of subjects who maintain loss of 3% or more of their body weight | Proportion of subjects who maintain loss of 3% or more of their body weight from baseline of the Epitomee core study to week 24 of the extension study | 24 weeks | 
| Proportion of subjects who lose or maintain loss of 5 % or more of their body weight | Proportion of subjects who lose or maintain loss of 5 % or more of their body weight from baseline of the Epitomee core study to week 24 of the extension study | 24 weeks | 
| Change in plasma fasting glucose | Change in plasma fasting glucose from baseline of the Epitomee core study to week 24 of the extension study | 24 weeks | 
| Change in glycemic status (Normoglycemia, Prediabetes and Diabetes) | Change in glycemic status (Normoglycemia, Prediabetes and Diabetes) between the Epitomee core study baseline and week 24 of the extension study | 24 weeks | 
| Changes in BMI reduction | Changes in BMI reduction between baseline BMI in the Epitomee core study and week 24 of the extension study. | 24 weeks |