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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
Summary
This trial tests the Epitomee Capsule, a pill to help with weight loss, in overweight and obese patients, including those with prediabetes. The capsule is expected to help reduce body weight by making people feel full or burning more calories. The study aims to show that this capsule, along with lifestyle changes, works better than not taking the capsule.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The difference between the percent body weight loss between the active and control groups
The proportion of treatment responders in the active group
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
2021
N/A
~320
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity work through various mechanisms to help reduce food intake and promote weight loss. Appetite suppressants act on the central nervous system to decrease hunger, while metabolic rate enhancers increase the body's energy expenditure.
Treatments like the Epitomee Capsule expand in the stomach, creating a sensation of fullness and thereby reducing food intake. These mechanisms are crucial for obesity patients as they address the fundamental issue of caloric intake and energy balance, making it easier to achieve and maintain a healthy weight.
Pharmacotherapy of obesity: emerging drugs and targets.
Pharmacotherapy of obesity: emerging drugs and targets.
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Who is running the clinical trial?
Epitomee medicalLead Sponsor
3 Previous Clinical Trials
121 Total Patients Enrolled
2 Trials studying Obesity
111 Patients Enrolled for Obesity
Yael Kenan, DrStudy DirectorEpitomee Medical, VP Clinical Affairs
1 Previous Clinical Trials
33 Total Patients Enrolled
1 Trials studying Obesity
33 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
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