The Effect of Extended Use of the EPITOMEE CAPSULE
Primary Purpose
Overweight and Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epitomee Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
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.
Sites / Locations
- University of Alabama Department of Nutrition Sciences
- Wake Forest School of Medicine, Wake Forest Baptist Health - 525 Vine Street, 5th Floor, Suite 5119
- Center for Weight and Eating Disorders at Perelman School of Medicine University of Pennsylvania - 3400 Civic Center Boulevard, Building 421,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epitomee Capsule
Arm Description
Epitomee Capsule combined with lifestyle counseling
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
Change in plasma fasting glucose
Change in plasma fasting glucose from baseline of the Epitomee core study to week 24 of the extension study
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
Changes in BMI reduction
Changes in BMI reduction between baseline BMI in the Epitomee core study and week 24 of the extension study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04994769
Brief Title
The Effect of Extended Use of the EPITOMEE CAPSULE
Official Title
The Effect of Extended Use of the Epitomee Capsule on Body Weight in Subjects With Overweight and Obesity With and Without Prediabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epitomee medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Effect of Extended Use of the Epitomee Capsule on BodyWeight in subjects with Overweight and Obesity with and without Prediabetes
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epitomee Capsule
Arm Type
Experimental
Arm Description
Epitomee Capsule combined with lifestyle counseling
Intervention Type
Device
Intervention Name(s)
Epitomee Capsule
Other Intervention Name(s)
The MODEL IBT Program
Intervention Description
Epitomee Capsule combined with lifestyle counseling.
Primary Outcome Measure Information:
Title
Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule
Description
Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule during the course of the study
Time Frame
24 weeks
Title
Change in percent weight loss
Description
Change in percent weight loss between baseline weight of the Epitomee core study and week 24 of the extension study
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Overall incidence, causality and severity of adverse events, potentially related to Epitomee capsule.
Description
Overall incidence, causality and severity of adverse events, potentially related to Epitomee capsule during the course of the study
Time Frame
24 weeks
Title
Proportion of subjects who maintain loss of 3% or more of their body weight
Description
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
Time Frame
24 weeks
Title
Proportion of subjects who lose or maintain loss of 5 % or more of their body weight
Description
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
Time Frame
24 weeks
Title
Change in plasma fasting glucose
Description
Change in plasma fasting glucose from baseline of the Epitomee core study to week 24 of the extension study
Time Frame
24 weeks
Title
Change in glycemic status (Normoglycemia, Prediabetes and Diabetes)
Description
Change in glycemic status (Normoglycemia, Prediabetes and Diabetes) between the Epitomee core study baseline and week 24 of the extension study
Time Frame
24 weeks
Title
Changes in BMI reduction
Description
Changes in BMI reduction between baseline BMI in the Epitomee core study and week 24 of the extension study.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Kenan, Dr
Organizational Affiliation
VP Clinical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Department of Nutrition Sciences
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Wake Forest School of Medicine, Wake Forest Baptist Health - 525 Vine Street, 5th Floor, Suite 5119
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Center for Weight and Eating Disorders at Perelman School of Medicine University of Pennsylvania - 3400 Civic Center Boulevard, Building 421,
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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The Effect of Extended Use of the EPITOMEE CAPSULE
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