Your session is about to expire
← Back to Search
Other
Epitomee Capsule for Obesity (RESET Trial)
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
RESET Trial Summary
This trial found that Epitomee Capsule had no significant effect on body weight in patients with overweight and obesity with and without Prediabetes.
Who is the study for?
Adults aged 18 or older with a BMI of 25.0-40.0 kg/m2, who have tried and failed to lose weight before, can join this trial if they're not pregnant, breastfeeding, or planning pregnancy soon. They must be willing to follow the study's diet and exercise program, avoid certain medications that affect weight, and have stable mental health if on psychiatric drugs.Check my eligibility
What is being tested?
The trial is testing the Epitomee Capsule against a placebo to see its effects on body weight in overweight or obese adults. Some participants may also have prediabetes but not full-blown diabetes.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks could include gastrointestinal issues due to the nature of an ingestible capsule designed for weight loss.
RESET Trial 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
The difference between the percent body weight loss between the active and control groups
The proportion of treatment responders in the active group
RESET Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Epitomee CapsuleExperimental Treatment1 Intervention
Epitomee Capsule combined with moderate intensity lifestyle counseling
Group II: Control-PlaceboPlacebo Group1 Intervention
Visually matching (to Epitomee capsule) placebo capsule combined with moderate intensity lifestyle counseling
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epitomee Capsule
2020
N/A
~280
Find a Location
Who is running the clinical trial?
Epitomee medicalLead Sponsor
3 Previous Clinical Trials
138 Total Patients Enrolled
2 Trials studying Obesity
128 Patients Enrolled for Obesity
Yael Kenan, DrStudy DirectorEpitomee Medical, VP Clinical Affairs
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Obesity
50 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking long-term steroids or medications that weaken your immune system.You are willing to maintain a diet in accordance with study requirement for the duration of the study.You have been diagnosed with HIV, hepatitis B, or hepatitis C in the past.You have lost more than 10 pounds in the last 6 months.You have had a severe allergic reaction to any medication or supplement in the past.You have a history of hormonal problems that affect your weight.You have either type 1 or type 2 diabetes.You have been diagnosed with certain eating disorders or have a habit of consuming a lot of liquid calories.You are currently taking psychiatric medications and have never had suicidal thoughts or behaviors in your life.You regularly use laxatives or take prescription medication for long-term constipation.You have a serious medical condition that could make your life expectancy less than a year, or you have severe kidney, liver, or lung problems.Women who are not pregnant according to a urine pregnancy test.You have normal blood sugar levels, with a fasting plasma glucose less than 100 mg/dL and HbA1c less than 5.7%.You have tried to lose weight before with the help of a doctor or on your own, but it didn't work.You have a history of heart problems, high blood pressure that isn't well controlled, or advanced kidney disease.You have had problems with drug or alcohol abuse within the last 5 years.You have taken medications or other substances that can make you gain or lose weight in the past 6 months.You tried to lose weight before with the help of a doctor or on your own, but it didn't work.You have had cancer in the past, except for non-melanoma skin cancer and very early stage cervical cancer.You have used a weight loss device in your stomach, like a gastric balloon or aspiration device, before.You quit smoking within the last 6 months or are thinking about quitting during the study.You are 18 years old or older.You are taking medications that can affect how quickly your stomach empties or how your blood clots.You have a high but not yet diabetic level of blood sugar, or you are taking a specific medication for prediabetes.You are non-pregnant, evidenced by a negative urine dipstick pregnancy test, and either surgically sterile or postmenopausal or agree to continue using an accepted method of birth control during the study.You cannot take certain pain medications, such as Ibuprofen and Naproxen, while participating in the study.Your current BMI is between 25.0 and 40.0.
Research Study Groups:
This trial has the following groups:- Group 1: Epitomee Capsule
- Group 2: Control-Placebo
Awards:
This trial has 0 awards, including: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: NCT04222322 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I partake in this research effort?
"In order to be considered for this medical trial, potential participants must have a BMI that is above the norm and fall within an age range of 18-70 years. Upwards of 230 people are being accepted in total."
Answered by AI
Is this trial accessible to participants who are over 30 years of age?
"The trial has stipulated a minimum age of 18 and a maximum age of 70 for those wishing to participate in this clinical experiment."
Answered by AI
Does this clinical trial still have available slots for participants?
"Affirmative, clinicaltrials.gov has evidence that this medical experiment is actively accepting applicants from the public. This trial was initiated on September 15th 2020 and most recently updated on November 23rd 2022; it hopes to enrol 230 participants at 5 separate sites."
Answered by AI
What is the geographic scope of this clinical trial's administration?
"Five sites across the United States are participating in this clinical trial. These include The Medical University of South carolina, Weight Management Center - 67 President Street, Suite 410 South (Charleston), Wake Forest School of Medicine and Wake Forest Baptist Health - 525 Vine Street, 5th Floor, Suite 5119 (Winston-Salem) as well as Washington Center for Weight Management and Research (Arlington)."
Answered by AI
What is the volume of individuals involved in this clinical experiment?
"Affirmative. Clinicaltrials.gov confirms that this trial, which was originally posted on September 15th 2020, is currently seeking participants with the goal of recruiting 230 individuals from 5 different research sites."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Pennsylvania
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
The University of Kansas, Department of Internal Medicine
Washington Center for Weight Management and Research
Other
Wake Forest School of Medicine, Wake Forest Baptist Health - 525 Vine Street, 5th Floor, Suite 5119
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I'm motivated to live a healthy life. I am hoping this clinical trial could work for me.
PatientReceived 2+ prior treatments
I need to loose weight,tried many ways but to no success. It cause me a lot of back pain.
PatientReceived no prior treatments
Because I tried to loose weight but it was unsuccessful, I am overweight and it is hard for me to lose weight.
PatientReceived no prior treatments
I had emergency surgery in 2017 for perforated diverticulitis and since then I cannot find a diet to lose the extra weight I put on after surgery and would like to be considered for this trial.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Are there any known side effects?
PatientReceived 1 prior treatment
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger