Loading clinical trials...

The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity | Clinical Trials | Clareo Health

COMPLETEDNA

The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity

The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity With and Without Prediabetes

NCT04222322•Epitomee medical

View on ClinicalTrials.gov

Summary

The effect of Epitomee Capsule on body weight in patients with overweight and obesity with and without Prediabetes

Detailed Description

This is a Prospective, Randomized, Double-blind, Placebo controlled, Multi-center, Pivotal, Adaptive trial designed to demonstrate that the use of Epitomee Capsule, in combination with lifestyle modification, is superior to the placebo device in reducing body weight at 24-weeks

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Men or women \>= 18 years
•2. Current BMI of 25.0-40.0 kg/m2 inclusive
•3. Eligible female subjects will be:
•Non-pregnant, evidenced by a negative urine dipstick pregnancy test Non-lactating Females will be either surgically sterile or postmenopausal or agree to continue using an accepted method of birth control during the study.
•4. Normoglycemic subjects with both:
•1. Fasting plasma glucose \<100 mg/dL
•2. HbA1c \<5.7% or:
•Prediabetic subjects with either one or both of the following criteria:
•1. FPG≥100 mg/dL and \<126 mg/dL
•2. 5.7% ≤ HbA1c ≤6.4% Naive Prediabetes or treated with metformin (up to 2000mg/dL inclusive)
+12 more criteria

Exclusion Criteria

•1. Pregnant or nursing, or plans to become pregnant in the next 12 months, or not using adequate contraceptive measures
•2. Weight loss of more than 10 pounds in the past 6 months
•3. Use in the past 6 months of medications or other substances known to induce weight gain or weight loss
•4. Participation in any clinical study (weight-loss or non-weight loss study) within the past 3 months
•5. Known history of endocrine disorders affecting weight, such as uncontrolled abnormal thyroid function, hypothalamic tumors, Cushing's syndrome, or other genetic syndromes
•6. Currently receiving chronic steroid or immunosuppressive therapy
•7. Subjects previously diagnosed with HIV, hepatitis B or C
•8. Subjects diagnosed with bulimia, binge eating disorder, compulsive overeating, high liquid calorie intake, or similar eating related psychological disorders
•9. Intent to undergo gastric surgery or gastric banding during the study period or within the 6-month period after completion of this study
•10. Prior use of any weight loss gastric medical device such as gastric balloon or gastric aspiration device
+27 more criteria

Locations (9)

University of Alabama, Dept of Nutrition Sciences

Birmingham, Alabama, United States

Northwestern University - 645 N. Michigan Avenue, Suite 530

Chicago, Illinois, United States

The University of Kansas, Department of Internal Medicine

Kansas City, Kansas, United States

L-MARC Research Center

Louisville, Kentucky, United States

Pennington Biomedical Research Center , 6400 Perkins Road

Baton Rouge, Louisiana, United States

Wake Forest School of Medicine, Wake Forest Baptist Health - 525 Vine Street, 5th Floor, Suite 5119

Winston-Salem, North Carolina, United States

Center for Weight and Eating Disorders at Perelman School of Medicine University of Pennsylvania - 3400 Civic Center Boulevard, Building 421,

Philadelphia, Pennsylvania, United States

Medical University of South Carolina, Weight Management Center - 67 President Street, Suite 410 South

Charleston, South Carolina, United States

Juno Resreach

Houston, Texas, United States

Key Dates

Start Date

September 15, 2020

Primary Completion Date

December 30, 2023

Completion Date

December 30, 2023

Last Updated

March 19, 2024

Enrollment

279

ACTUAL participants

Conditions

Overweight and Obesity

Interventions

Epitomee Capsule

DEVICE

Control-Placebo

OTHER

Nutrition Care in Patients Living With Chronic Pain

NCT06277232

Nutrition PoorOverweight and Obesity+2 more

View study

RECRUITINGNA

The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health

NCT07395973

Overweight and Obesity

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Effect of Epitomee Capsule on Body Weight in Patients With Overweight and Obesity

Inclusion Criteria

Exclusion Criteria

Nutrition Care in Patients Living With Chronic Pain

The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health

Social Determinants and a Diabetes Prevention Program Tailored for African Americans

Becoming United in Lifestyle Decisions

Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness

Protein Digestion After Bariatric Surgery in Older Adults