What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for obesity that create a feeling of fullness, such as GLP-1 analogs and expandable devices like the Epitomee Capsule, often have gastrointestinal side effects. These can include nausea, vomiting, diarrhea, constipation, abdominal pain, and bloating. GLP-1 analogs may also carry risks of pancreatitis and gallbladder disease. Patients should consult their healthcare provider to weigh these potential side effects against the benefits of treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity that aim to reduce food intake or create a feeling of fullness. One notable example is the combination of phentermine and topiramate (Qsymia), which has been shown to enhance weight loss by suppressing appetite and increasing satiety. Another approved drug is liraglutide (Saxenda), a GLP-1 receptor agonist that slows gastric emptying and promotes a feeling of fullness. These treatments, along with others like orlistat (Xenical), which reduces fat absorption, have been validated for their efficacy in weight management. The Epitomee Capsule, which expands in the stomach to create a feeling of fullness, is being studied for similar effects.

What other types of research exist?

Promising novel alternatives to the Epitomee Capsule for obesity treatment in 2024 include: 1) GLP-1 receptor agonists such as semaglutide and tirzepatide, which have shown significant weight loss in clinical trials. 2) Combination therapies like phentermine-topiramate, which have demonstrated enhanced weight loss compared to monotherapy. 3) Intragastric injection of botulinum toxin A, which has been effective in achieving moderate weight loss and improving quality of life. These alternatives offer different mechanisms of action and can be considered based on individual patient needs and medical advice.

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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

Do I qualify?Apply below to find out

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.