The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity With and Without Prediabetes
The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity With and Without Prediabetes
The effect of Epitomee Capsule on body weight in patients with overweight and obesity with
 and without Prediabetes
This is a Prospective, Randomized, Double-blind, Placebo controlled, Multi-center, Pivotal,
 Adaptive trial designed to demonstrate that the use of Epitomee Capsule, in combination with
 lifestyle modification, is superior to the placebo device in reducing body weight at 24-weeks
Inclusion Criteria:

 1. Men or women >= 18 years

 2. Current BMI of 25.0-40.0 kg/m2 inclusive

 3. Eligible female subjects will be:

 Non-pregnant, evidenced by a negative urine dipstick pregnancy test Non-lactating
 Females will be either surgically sterile or postmenopausal or agree to continue using
 an accepted method of birth control during the study.

 4. Normoglycemic subjects with both:

 1. Fasting plasma glucose <100 mg/dL

 2. HbA1c <5.7% or:

 Prediabetic subjects with either one or both of the following criteria:

 1. FPG≥100 mg/dL and <126 mg/dL

 2. 5.7% ≤ HbA1c ≤6.4% Naive Prediabetes or treated with metformin (up to 2000mg/dL
 inclusive)

 5. Ability to provide informed consent before any trial-related activities

 6. Ability and willingness to complete the physical activity in accordance to the study's
 exercise program

 7. Willingness to maintain a diet in accordance with study requirement for the duration
 of the study

 8. Subjects must have:

 -  A primary care provider who is responsible for providing routine care

 -  A reliable telephone or internet service to communicate with study staff

 9. Understand and be willing to comply with all study-related procedures and agree to
 participate in the study by giving written informed consent

 10. 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 trial.

 11. Previously attempted to lose weight unsuccessfully using a medically supervised or
 self-directed diet.

 12. Willingness to avoid medications or other substances known to affect weight changes
 during the study

 13. Willingness to avoid non-steroidal anti-inflammatory drugs (NSAIDs) other than low
 dose aspirin including Diclofenac, Ibuprofen, Naproxen, or other medications known to
 be gastric irritants during the study.

 14. Subjects on psychiatric medications are clinically well-controlled with a stable
 psychiatric medication dose for at least 3 months prior to study entry.

 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).