Safety and Feasibility Assessment of the Bio-electrical One Day Capsule System in Overweight and Class I Obese Participants

Study Overview
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Brief Summary
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The study represents the first effort to prospectively investigate the Melcap's bio-electrical ingestible ODC system in human. The study goal is to evaluate the safety and feasibility of GES treatment in stomach and in the small and large bowel during and following the ingestion of the bio-electrical capsule under tight and controlled conditions.

Detailed Description
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The problem of obesity in the adult population requires the exploration and development of new, safe and effective therapies to combat increasing growth. A novel Implantable Gastric Electrical Stimulation (GES), MEASTRO(R) Rechargeable System, has been recently approved by the American Food and Drug Administration (FDA) for use in weight reduction in patients aged 18 years through adulthood who have a Body Mass Index (BMI) of 40 to 45 kg/m2 with one or more obesity related co-morbid conditions, and have failed at least one supervised management program within the past 5 years. Melcap System Ltd. has developed an innovative ingestible capsule system device that uses GES for the treatment of overweight and obesity. The system is intended to suppress hunger, reduce appetite, increase satiation and promote weight reduction in overweight and class I obese adults who have a Body Mass Index of 27 kg/m2 to 34.9 kg/m2 with no related co-morbid conditions. The study is a FIH prospective, open label, randomized study. It will include a 3 days screening period and 4 days treatment session under a close supervision and follow up. Each subject will ingest a total of 2 capsules (ODC) on the first and the third day of the study. The total duration of subject participation including the termination visit will be eight days. The study will be conducted at a single medical center, Meir Hospital, Israel.

Official Title
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A First in Human (FIH) Study to Assess the Safety and Feasibility of the Bio-electrical One Day Capsule (ODC) System (Type 1 and 2 Capsules) in Overweight and Class 1 Obese Subjects

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Device: ODC system (type 1 capsule)
* Device: ODC system (type 2 capsule)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 21-65 years old at time of screening Body mass Index (BMI) >= 27 and <35 The subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 4 months prior to enrollment Female subjects at reproductive age that are tested negative for pregnancy Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods during the whole study duration No significant weight loss (<5%) within four months prior to enrollment (by self -report) No recorded or treated psychological disorder(s) for at least six months prior to enrollment (by self report) Not taking anti-depressant medication, for at least six months prior to enrollment. Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of he trial. Personally motivated and willing to comply with all the requirements of the clinical trial Able to understand, read and voluntary sign the inform consent form Agree and able to sign the consent form for the Pillcam(R) patency capsule test as is in use at Meir MC. Exclusion Criteria: History o abdominal or gastrointestinal surgery (appendectomy, hernia repair, gynecological surgeries and cholecystectomy more than a year ago are allowed) Prior bariatric surgery Implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator) Unwillingness to stop medication altering gastric pH and/or affecting GI motility during the entire study duration. Known diagnosed psychiatric conditions that may impair subject's ability to comply with the study procedures (by self-report) Use of anti-psychotic medications Diagnosed with an eating disorder including bulimia and binge eating Swallowing difficulties Significant active or unstable acute or chronic illnesses/ diseases including gastrointestinal, systemic (non-gastrointestinal) and psychiatric conditions Use of another investigation device or agent in the 30 days prior to enrollment Women who are pregnant, lactating or anticipate to becoming pregnant within the study duration Planned or contemplated use of Magnetic Resonance Imaging (MRI) or any (e.g. oncologic) radiation during the course of the trial. Have a family member who is currently participating in this clinical trial Any other conditions that, in the opinion of the investigator, would make the subject unsuitable for the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric electrical stimulation with type 2 ODC<br>Safety and feasibility assessment of the ODC system (type 2) capsule during and following gastric electrical stimulation protocol. | Device: ODC system (type 2 capsule)<br>* ODC (one day capsule) type 2 is ingested by a subject and passes through the gastrointestinal tract. Electrical stimulation is the transferred from the capsule to the surrounding GI tissues. The capsule is excreted from the body through the intestinal tract in a natural manner with bowel movement.<br>|
| Experimental: Electrical stimulation with type 2 ODC<br>Safety and feasibility assessment of the ODC system (type 2) capsule during and following small and large bowel electrical stimulation protocol. | Device: ODC system (type 2 capsule)<br>* ODC (one day capsule) type 2 is ingested by a subject and passes through the gastrointestinal tract. Electrical stimulation is the transferred from the capsule to the surrounding GI tissues. The capsule is excreted from the body through the intestinal tract in a natural manner with bowel movement.<br>|
| Experimental: Electrical stimulation with type 1 ODC<br>Safety and feasibility assessment of the ODC system (type 1 capsule) during and following small and large electrical stimulation protocol. | Device: ODC system (type 1 capsule)<br>* ODC (one day capsule) type 1 is ingested by a subject and passes through the gastrointestinal tract. Electrical stimulation is the transferred from the capsule to the surrounding GI tissues. The capsule is excreted from the body through the intestinal tract in a natural manner with bowel movement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and severity of all adverse events | Safety evaluation | During the whole study duration (approximately 8 days) | 
| Incidence of device-related adverse events | Safety evaluation | During the whole study duration (approximately 8 days) | 
| Incidence of clinically significant abnormal laboratory values as determined by the investigator | Safety evaluation | During the whole study duration (approximately 8 days) | 
| Excretion of the study capsules in a natural manner | Safety evaluation - confirmation of the capsule excretion from the body | up to 3 days after the days of the capsules ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety levels | Changes in satiety levels resulting of the electrical stimulation | Day #1 and #3 of the treatment period | 
| Appetite levels | Changes in appetite levels resulting of the electrical stimulation | Day #1 and #3 of the treatment period | 
| Postprandial symptoms | Evaluation of postprandial symptoms during the treatment period | Day #1, #2, #3 and #4 of the treatment period | 
| Response to nutrient drink test | Determination of the maximum tolerable drinking volume followed by postprandial symptoms measurement | Day #3 of the screening period and and day #4 of the treatment period | 
| Appetite-related hormone | Evaluation of appetite- related hormones levels change as a result of the stimulation applied | Day #1 and Day #3 of the treatment period |