The Effect of Extended Use of the EPITOMEE CAPSULE (ELECT)

NCT04994769 | Completed FDA Device

• 1 other identifier: PRT-05-032
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Overall incidence, causality and severity of adverse events, potentially related to Epitomee capsule.

  24 weeks

• Proportion of subjects who maintain loss of 3% or more of their body weight

  24 weeks

• Proportion of subjects who lose or maintain loss of 5 % or more of their body weight

  24 weeks

• Change in plasma fasting glucose

  24 weeks

• Change in glycemic status (Normoglycemia, Prediabetes and Diabetes)

  24 weeks

Study Arms (1)

Epitomee Capsule

EXPERIMENTAL

Epitomee Capsule combined with lifestyle counseling

Device: Epitomee Capsule

Interventions

Epitomee Capsule DEVICE

Epitomee Capsule combined with lifestyle counseling.

Also known as: The MODEL IBT Program

Epitomee Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Epitomee medical: lead

Study Sites (3)

University of Alabama Department of Nutrition Sciences

Birmingham, Alabama, 35294, United States

Location

Wake Forest School of Medicine, Wake Forest Baptist Health - 525 Vine Street, 5th Floor, Suite 5119

Winston-Salem, North Carolina, 27101, United States

Location

Center for Weight and Eating Disorders at Perelman School of Medicine University of Pennsylvania - 3400 Civic Center Boulevard, Building 421,

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Kamar M, Ryan DH, Leonard S, Wyatt HR, Kenan Y, Asaraf LC, Ganon-Elazar E, Ard JD. The safety and efficacy of extended use of an oral shape-shifting superabsorbent hydrogel capsule for weight loss: The ELECT extension study. Obes Pillars. 2025 Oct 20;16:100216. doi: 10.1016/j.obpill.2025.100216. eCollection 2025 Dec.

  PMID: 41216379 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yael Kenan, Dr

  VP Clinical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: August 31, 2021
• Primary Completion: December 28, 2023
• Study Completion: March 30, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

US (3)