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Overweight and ObesityRESETNCT04222322

The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity

A study testing Epitomee Capsule in people with Overweight and Obesity, run by Epitomee medical at 9 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The effect of Epitomee Capsule on body weight in patients with overweight and obesity with and without Prediabetes Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
Epitomee Capsule
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
279 participants
Where
9 sitesUnited States
Study dates
15 Sep 2020to 30 Dec 2023
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men or women >= 18 years
  • Current BMI of 25.0-40.0 kg/m2 inclusive
  • 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.
  • Normoglycemic subjects with both:
  • Fasting plasma glucose <100 mg/dL
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  • HbA1c <5.7% or:
  • Prediabetic subjects with either one or both of the following criteria:
  • FPG≥100 mg/dL and <126 mg/dL
  • 5.7% ≤ HbA1c ≤6.4% Naive Prediabetes or treated with metformin (up to 2000mg/dL inclusive)
  • Ability to provide informed consent before any trial-related activities
  • Ability and willingness to complete the physical activity in accordance to the study's exercise program
  • Willingness to maintain a diet in accordance with study requirement for the duration of the study
  • 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
  • Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
  • 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.
  • Previously attempted to lose weight unsuccessfully using a medically supervised or self-directed diet.
  • Willingness to avoid medications or other substances known to affect weight changes during the study
  • 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.
  • Subjects on psychiatric medications are clinically well-controlled with a stable psychiatric medication dose for at least 3 months prior to study entry.

Who cannot join

  • Pregnant or nursing, or plans to become pregnant in the next 12 months, or not using adequate contraceptive measures
  • Weight loss of more than 10 pounds in the past 6 months
  • Use in the past 6 months of medications or other substances known to induce weight gain or weight loss
  • Participation in any clinical study (weight-loss or non-weight loss study) within the past 3 months
  • Known history of endocrine disorders affecting weight, such as uncontrolled abnormal thyroid function, hypothalamic tumors, Cushing's syndrome, or other genetic syndromes
  • Currently receiving chronic steroid or immunosuppressive therapy
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  • Subjects previously diagnosed with HIV, hepatitis B or C
  • Subjects diagnosed with bulimia, binge eating disorder, compulsive overeating, high liquid calorie intake, or similar eating related psychological disorders
  • Intent to undergo gastric surgery or gastric banding during the study period or within the 6-month period after completion of this study
  • Prior use of any weight loss gastric medical device such as gastric balloon or gastric aspiration device
  • 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
  • Known history of any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
  • 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.
  • 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
  • Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
  • Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
  • 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
  • Subjects with Type 1 diabetes or type 2 diabetes
  • 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
  • Poorly controlled hypertension (≥ 160 mmHg systolic and ≥ 100mmHg diastolic)
  • End stage renal disease or requiring hemodialysis within the past 6 months
  • Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
  • 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
  • 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).
  • Study subjects must not have a medical history of sensitivity, intolerance, or toxicity to the investigational product, or agents similar to the investigational product.
  • Study subjects must not have a history of anaphylaxis or anaphylactoid reaction to any prior drug or supplement of any kind.
  • Study subjects must not have a history of cancer with the exception of non-melanoma skin cancer and "in situ" cancer of the cervix.
  • 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.
  • 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.
  • Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
  • Subjects who are habitual laxative users or using prescription medication for chronic constipation
  • Study subjects must not have change in medications treating hypertension and/or dyslipidemia within 1 month prior to Screening Visit (including change in dose)
  • Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition.
  • Subject is employed by the investigator, or is a close relative of the investigator, or the investigator's staff
  • 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.
  • Subjects on psychiatric medications with no lifetime history of suicidal behavior.
  • 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).

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Pennington Biomedical Research Center , 6400 Perkins Road

    Baton Rouge, Louisiana, 70808

  • University of Alabama, Dept of Nutrition Sciences

    Birmingham, Alabama, 35294

  • Medical University of South Carolina, Weight Management Center - 67 President Street, Suite 410 South

    Charleston, South Carolina, 29425

  • Northwestern University - 645 N. Michigan Avenue, Suite 530

    Chicago, Illinois, 60611

  • Juno Resreach

    Houston, Texas, 77040

  • The University of Kansas, Department of Internal Medicine

    Kansas City, Kansas, 66160

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • 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 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

Read the detailed description

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

Being tested
Epitomee Capsule, Control-Placebo
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

    Arm treatment: Epitomee Capsule combined with moderate intensity lifestyle counseling.

  • Control-PlaceboOther

    Arm treatment: Visually matching placebo capsule combined with moderate intensity lifestyle counseling.

Study groups in NCT04222322
Study groupRoleWhat they receive
Epitomee CapsuleExperimentalEpitomee Capsule combined with moderate intensity lifestyle counseling
Receives: Device: Epitomee Capsule
Control-PlaceboPlacebo comparatorVisually matching (to Epitomee capsule) placebo capsule combined with moderate intensity lifestyle counseling
Receives: Other: Control-Placebo

What is being measured

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

  1. The difference between the percent body weight loss between the active and control groups

    The difference between the percent average body weight loss at 24-weeks post randomization between the active and control groups

    Measured: 24 weeks

  2. The proportion of treatment responders in the active group

    The proportion of treatment responders defined as subjects who have lost 5% or more of baseline weight at 24-weeks post randomization, among the active group

    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 posted9 Jan 2020
  2. Study start15 Sep 2020
  3. Primary completion30 Dec 2023
  4. Study completion30 Dec 2023

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04222322
Sponsor's protocol ID
PRT-05-031
Acronym
RESET
Status last verified
Mar 2024
First submitted
30 Dec 2019
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Kushner RF, Ard JD, Wadden TA, O'Neil PM, Bays HE, Greenway FL, Jakicic JM, Wyatt HR, Kenan Y, Asaraf LC, Ryan DH. Quality of life improvements associated with weight loss using a novel shape-shifting hydrogel capsule: RESET study results. Int J Obes (Lond). 2026 Jan;50(1):159-165. doi: 10.1038/s41366-025-01910-6. Epub 2025 Sep 16.

    PubMed 40957899

  • Bays HE, Ard JD, O'Neil PM, Wadden TA, Kushner RF, Jakicic JM, Wyatt HR, Greenway FL, Kamar M, Ganon-Elazar E, Asaraf LC, Ryan DH. Weight and cardiometabolic effects of a novel oral shape-shifting superabsorbent hydrogel capsule: Prespecified and exploratory analysis of the Epitomee capsule RESET study. Obes Pillars. 2025 Jan 31;13:100163. doi: 10.1016/j.obpill.2025.100163. eCollection 2025 Mar.

    PubMed 40028615

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 9 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 22 inclusion and 37 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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. Some participants in this study may receive a placebo. 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?

The difference between the percent body weight loss between the active and control groups (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 NCT04222322, which also lists 2 linked publications.

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 19 Mar 2024.

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