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Not Applicable
Epitomee Capsule for Weight Loss
N/A
Waitlist Available
Research Sponsored by Epitomee medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females must be either surgically sterile or postmenopausal or agree to continue using an accepted method of birth control during the study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial is testing a new weight-loss drug in people who are overweight or obese, with or without prediabetes.
Who is the study for?
This trial is for adults with obesity or overweight and prediabetes who have lost at least 3% body weight in a previous study. They must be non-pregnant, able to use birth control if applicable, avoid NSAIDs (except low-dose aspirin or Celebrex), have stable psychiatric medication if used, and commit to a lifestyle program. A primary care physician and access to cellphone/internet are required.Check my eligibility
What is being tested?
The Epitomee Capsule's extended use on body weight management is being tested in individuals with obesity/overweight conditions, some of whom may also have prediabetes. The study examines whether longer-term use can help maintain or further reduce body weight.See study design
What are the potential side effects?
While the specific side effects of the Epitomee Capsule aren't listed here, similar treatments might cause digestive discomforts such as nausea or abdominal pain. Participants should report any new health changes that could relate to capsule usage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either surgically sterile, postmenopausal, or will use birth control during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in percent weight loss
Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule
Secondary outcome measures
Change in glycemic status (Normoglycemia, Prediabetes and Diabetes)
Change in plasma fasting glucose
Changes in BMI reduction
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Epitomee CapsuleExperimental Treatment1 Intervention
Epitomee Capsule combined with lifestyle counseling
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epitomee Capsule
2020
N/A
~280
Who is running the clinical trial?
Epitomee medicalLead Sponsor
3 Previous Clinical Trials
367 Total Patients Enrolled
2 Trials studying Obesity
357 Patients Enrolled for Obesity
Yael Kenan, DrStudy DirectorVP Clinical Affairs
1 Previous Clinical Trials
279 Total Patients Enrolled
1 Trials studying Obesity
279 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will inform the study team about any changes in my health or medications.My mental health is stable, and I've been on the same psychiatric medication dose for 3 months.I am not using NSAIDs and am willing to avoid them, except for low-dose aspirin or Celebrex.I regularly use laxatives or prescription medication for chronic constipation.I plan to have stomach surgery or get a gastric band during the study.I have prediabetes and have been taking up to 2000 mg of metformin daily for at least a month.I have stomach issues like ulcers, chronic pain, or nausea.I have a condition that affects my esophagus, making it hard for things to pass through.I have trouble swallowing or severe heartburn that medication doesn't help.I experience recurring stomach pain, nausea, or vomiting after meals.I haven't taken any stomach-irritating medications for 4 weeks.I finished 24 weeks of the study and missed no more than two visits.I have a blockage or serious condition in my digestive system.I am not using NSAIDs and can avoid them, except for low-dose aspirin or Celebrex.I am currently on long-term steroids or medications that suppress my immune system.I am either surgically sterile, postmenopausal, or will use birth control during the study.I have started taking anti-platelet drugs other than low-dose Aspirin in the last 6 months.I started taking medication for seizures or heart rhythm problems in the last 6 months.My blood pressure is very high (160/100 mmHg or more).I have heart issues like heart failure or had a heart attack or surgery within the last year.I have a condition like irritable bowel syndrome or Crohn's disease.I started medication for high blood pressure or cholesterol less than a month ago.I don't have any health issues that could affect my participation in the study.I am willing to avoid substances that can change my weight during the study.You must have a primary care physician (PCP) who is responsible for providing routine care.I am a woman who is either surgically sterile, postmenopausal, or will use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Epitomee Capsule
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT04994769 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on patient participation in this research project?
"Affirmative, clinicaltrials.gov lists this medical trial as actively seeking participants. It was first posted on August 31st 2021 and modified lastly on November 16th 2022; four sites are recruiting for a total of 50 patients."
Answered by AI
At what volume of medical facilities is this trial being conducted in Canada?
"The Pennington Biomedical Research Center, University of Alabama Department of Nutrition Sciences, and Wake Forest School of Medicine are each offering the trial to potential participants. Additionally, there exist 4 other clinical sites where enrolment is possible."
Answered by AI
What is the overarching goal of this research endeavor?
"The primary evaluation of this 24-week experiment is the incidence, causality and severity of serious adverse events associated with Epitomee capsule. Secondary outcomes measure include changes in fasting plasma glucose from baseline to week 24, the proportion of subjects who maintain a 3% or more body weight loss, and an overall assessment of incidences related to taking Epitomee capsules."
Answered by AI
Are there any more vacancies for this medical experiment?
"The details published on clinicaltrials.gov signify that participants are being actively sought for this trial, which was initially announced in August 2021 and recently updated in November 2022."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
New Jersey
Other
Louisiana
How old are they?
65+
18 - 65
What site did they apply to?
Other
Wake Forest School of Medicine, Wake Forest Baptist Health - 525 Vine Street, 5th Floor, Suite 5119
Pennington Biomedical Research Center , 6400 Perkins Road
Center for Weight and Eating Disorders at Perelman School of Medicine University of Pennsylvania - 3400 Civic Center Boulevard, Building 421,
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
I need to lose weight before I reach the stage of diabetes. I am seeking to use weight loss drugs to address my persistent weight issues.
PatientReceived no prior treatments
I’ve tried dieting with lots of failure. I would love to be a candidate to try some new drugs on the market.
PatientReceived 1 prior treatment
I’m trying to get my weight under control but I’m always hungry. I have been able to loose weight but never long term and would be a good volunteer for your study!
PatientReceived 2+ prior treatments
I have been on 2000mg of metformin in the past w little results. I have been diagnosed w insulin resistance and pre-diabetes. I'm very interested in decreasing my risk for diabetes thru weight loss.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
I am unfamiliar w this drug. Does it go by any other name? Can I do the trial from Australia or do you have one in Australia?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- University of Alabama Department of Nutrition Sciences: < 48 hours
Average response time
- < 2 Days
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