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Overweight and ObesityNCT04994769

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

A study testing Epitomee Capsule in people with Overweight and Obesity, run by Epitomee medical at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Effect of Extended Use of the Epitomee Capsule on BodyWeight in subjects with Overweight and Obesity with and without Prediabetes Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Epitomee Capsule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
3 sitesUnited States
Study dates
31 Aug 2021to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Alabama Department of Nutrition Sciences

    Birmingham, Alabama, 35294

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

    Philadelphia, Pennsylvania, 19104

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

    Winston-Salem, North Carolina, 27101

Other trials in United States

About this study

Official title: The Effect of Extended Use of the Epitomee Capsule on Body Weight in Subjects With Overweight and Obesity With and Without Prediabetes

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

Read the 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.

Being tested
Epitomee Capsule
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epitomee CapsuleDevice

    Also called The MODEL IBT Program

    Epitomee Capsule combined with lifestyle counseling.

Study groups in NCT04994769
Study groupRoleWhat they receive
Epitomee CapsuleExperimentalEpitomee Capsule combined with lifestyle counseling
Receives: Device: Epitomee Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 weeks

  2. 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

    Measured: 24 weeks

Secondary outcomes (6)

  1. 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

    Measured: 24 weeks

  2. 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

    Measured: 24 weeks

  3. 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

    Measured: 24 weeks

  4. Change in plasma fasting glucose

    Change in plasma fasting glucose from baseline of the Epitomee core study to week 24 of the extension study

    Measured: 24 weeks

  5. 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

    Measured: 24 weeks

  6. Changes in BMI reduction

    Changes in BMI reduction between baseline BMI in the Epitomee core study and week 24 of the extension study.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start31 Aug 2021
  3. Primary completion28 Dec 2023
  4. Study completion30 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04994769
Sponsor's protocol ID
PRT-05-032
Status last verified
Apr 2024
First submitted
29 Jul 2021
Last updated
2 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 41216379

Questions about this trial

What is this clinical trial studying?

A study testing Epitomee Capsule in people with Overweight and Obesity, run by Epitomee medical at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04994769, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.

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