What side effects are associated with this type of intervention?

Common treatments for obesity that focus on appetite suppression and altered gastrointestinal function, such as GLP-1 receptor agonists (liraglutide, semaglutide), orlistat, and phentermine-topiramate, often have gastrointestinal side effects. These can include nausea, vomiting, diarrhea, and constipation. Orlistat specifically can cause oily stools, flatulence, and frequent bowel movements due to its fat absorption blocking mechanism. Phentermine-topiramate may also lead to dry mouth, insomnia, and increased heart rate. These side effects are important to consider when discussing treatment options with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity that involve appetite suppression or altered gastrointestinal function. One notable example is the combination of phentermine and topiramate, which has been shown to enhance weight loss by suppressing appetite. Another example is GLP-1 receptor agonists like liraglutide, which not only help in weight loss but also improve glycemic control by slowing gastric emptying and increasing satiety. These treatments have demonstrated efficacy in clinical trials and are commonly used in managing obesity.

What other types of research exist?

Promising novel alternatives to the Epitomee Capsule for obesity treatment in 2024 include: 1) GLP-1 receptor agonists like semaglutide, which have shown significant weight loss benefits. 2) Amylin analogues such as cagrilintide, which are being investigated for their potential in weight management. 3) Combination therapies, such as the concomitant use of cagrilintide with semaglutide, which have demonstrated enhanced efficacy in clinical trials.

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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

Must not have

Subjects who are habitual laxative users or using prescription medication for chronic constipation

Intending to undergo gastric surgery or gastric banding during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of the Epitomee Capsule in people who are overweight or obese, including those with prediabetes. The capsule helps people feel full and eat less, aiding in weight loss. Participants have already lost some weight using the capsule and will continue to use it along with lifestyle changes.

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.

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.

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 below

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I am either surgically sterile, postmenopausal, or will use birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use laxatives or prescription medication for chronic constipation.

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I plan to have stomach surgery or get a gastric band during the study.

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I have stomach issues like ulcers, chronic pain, or nausea.

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I have a condition that affects my esophagus, making it hard for things to pass through.

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I have trouble swallowing or severe heartburn that medication doesn't help.

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I experience recurring stomach pain, nausea, or vomiting after meals.

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I have a blockage or serious condition in my digestive system.

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I am currently on long-term steroids or medications that suppress my immune system.

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I have started taking anti-platelet drugs other than low-dose Aspirin in the last 6 months.

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I started taking medication for seizures or heart rhythm problems in the last 6 months.

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My blood pressure is very high (160/100 mmHg or more).

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I have heart issues like heart failure or had a heart attack or surgery within the last year.

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I have a condition like irritable bowel syndrome or Crohn's disease.

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

Change in percent weight loss

Incidence, causality, and severity of serious adverse events, potentially related to Epitomee capsule

Secondary study objectives

Change in glycemic status (Normoglycemia, Prediabetes and Diabetes)

Change in plasma fasting glucose

Changes in BMI reduction

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

2021

N/A

~320

0 / 14Eligibility criteria met

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 often target appetite suppression and altered gastrointestinal function. Appetite suppressants, such as GLP-1 receptor agonists, work by mimicking hormones that signal fullness to the brain, thereby reducing food intake. Treatments like the Epitomee Capsule aim to alter gastrointestinal function by expanding in the stomach to create a sense of fullness, which helps reduce calorie intake. These mechanisms are crucial for obesity patients as they directly address overeating and help manage weight by promoting a feeling of satiety, making it easier to adhere to a reduced-calorie diet.

Pharmacotherapy of obesity: emerging drugs and targets.