The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity

Exclusion Criteria

• •1. Pregnant or nursing, or plans to become pregnant in the next 12 months, or not using adequate contraceptive measures
• •2. Weight loss of more than 10 pounds in the past 6 months
• •3. Use in the past 6 months of medications or other substances known to induce weight gain or weight loss
• •4. Participation in any clinical study (weight-loss or non-weight loss study) within the past 3 months
• •5. Known history of endocrine disorders affecting weight, such as uncontrolled abnormal thyroid function, hypothalamic tumors, Cushing's syndrome, or other genetic syndromes
• •6. Currently receiving chronic steroid or immunosuppressive therapy
• •7. Subjects previously diagnosed with HIV, hepatitis B or C
• •8. Subjects diagnosed with bulimia, binge eating disorder, compulsive overeating, high liquid calorie intake, or similar eating related psychological disorders
• •9. Intent to undergo gastric surgery or gastric banding during the study period or within the 6-month period after completion of this study
• •10. Prior use of any weight loss gastric medical device such as gastric balloon or gastric aspiration device
• •11. Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including: Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus
• •12. Known history of any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
• •13. Known history of 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.
• •14. Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal (GI) tract
• •15. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
• •16. Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
• •17. Known history of GI surgeries that may have resulted in anatomical GI tract abnormalities such as a stoma, Nissen Fundoplication or narrowing of any portion of the digestive tract. Examples of these GI surgeries include, but are not limited to, gastric banding; however, uncomplicated appendectomies are acceptable. In addition, known history of any surgeries that may have resulted in anatomical GI tract abnormalities such intestinal adhesions, or any other condition that may inhibit passage through any portion of the GI tract must be excluded
• •18. Subjects with Type 1 diabetes or type 2 diabetes
• •19. Experienced a myocardial infarction, has a known history of angina, underwent coronary bypass, a known history of congestive heart failure, or is currently being medically treated for any other cardiac condition
• •20. Poorly controlled hypertension (≥ 160 mmHg systolic and ≥ 100mmHg diastolic)
• •21. End stage renal disease or requiring hemodialysis within the past 6 months
• •22. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
• •23. Subjects requiring the use of anti-platelet drugs (except for low dose Aspirin as mentioned above) or other agents affecting the normal clotting of blood
• •24. Study subjects must not have a history of substance use disorder (licit or illicit) drug or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).
• •25. Study subjects must not have a medical history of sensitivity, intolerance, or toxicity to the investigational product, or agents similar to the investigational product.
• •26. Study subjects must not have a history of anaphylaxis or anaphylactoid reaction to any prior drug or supplement of any kind.
• •27. Study subjects must not have a history of cancer with the exception of non-melanoma skin cancer and "in situ" cancer of the cervix.
• •28. Study subjects must not be anticipating a significant change in job, job duties, or job work hours, which might impair their ability and willingness to undergo study-related procedures under the timelines specified by protocol, and otherwise impede their completion of the study.
• •29. Study subjects must not anticipate a reasonable likelihood of moving away from the research site, wherein such a move might impair their ability and willingness to undergo study-related procedures within the timelines specified by protocol, or otherwise impede their completion of the study.
• •30. Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
• •31. Subjects who are habitual laxative users or using prescription medication for chronic constipation
• •32. Study subjects must not have change in medications treating hypertension and/or dyslipidemia within 1 month prior to Screening Visit (including change in dose)
• •33. Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition.
• •34. Subject is employed by the investigator, or is a close relative of the investigator, or the investigator's staff
• •35. Subject is a close relative of another subject already enrolled in the study or lives in the same home with another subject enrolled in the study.
• •36. Subjects on psychiatric medications with no lifetime history of suicidal behavior.
• •37. 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., psycho-social issues).