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

Completed · Not applicable · Has a placebo group

Conditions studied: Overweight and Obesity

In brief

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

Key facts

Study ID: NCT04222322
Run by: Epitomee medical
People needed: 279
Starts: 2020-09-15
Expected to finish: 2023-12-30
Last updated by the study team: 2024-03-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Men or women >= 18 years
Current BMI of 25.0-40.0 kg/m2 inclusive
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.
Normoglycemic subjects with both:
Fasting plasma glucose <100 mg/dL
HbA1c <5.7% or:
Prediabetic subjects with either one or both of the following criteria:
FPG≥100 mg/dL and <126 mg/dL
5.7% ≤ HbA1c ≤6.4% Naive Prediabetes or treated with metformin (up to 2000mg/dL inclusive)
Ability to provide informed consent before any trial-related activities
Ability and willingness to complete the physical activity in accordance to the study's exercise program
Willingness to maintain a diet in accordance with study requirement for the duration of the study
Subjects must have:
A primary care provider who is responsible for providing routine care
A reliable telephone or internet service to communicate with study staff
Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
Study subjects must be willing to notify the staff of any change in their medical health (including surgeries) or change in drug treatments (addition of drugs, stopping of drugs, or change in drug dose) during the course of the trial.
Previously attempted to lose weight unsuccessfully using a medically supervised or self-directed diet.
Willingness to avoid medications or other substances known to affect weight changes during the study
Willingness to avoid non-steroidal anti-inflammatory drugs (NSAIDs) other than low dose aspirin including Diclofenac, Ibuprofen, Naproxen, or other medications known to be gastric irritants during the study.
Subjects on psychiatric medications are clinically well-controlled with a stable psychiatric medication dose for at least 3 months prior to study entry.

You may not qualify if…

Pregnant or nursing, or plans to become pregnant in the next 12 months, or not using adequate contraceptive measures
Weight loss of more than 10 pounds in the past 6 months
Use in the past 6 months of medications or other substances known to induce weight gain or weight loss
Participation in any clinical study (weight-loss or non-weight loss study) within the past 3 months
Known history of endocrine disorders affecting weight, such as uncontrolled abnormal thyroid function, hypothalamic tumors, Cushing's syndrome, or other genetic syndromes
Currently receiving chronic steroid or immunosuppressive therapy
Subjects previously diagnosed with HIV, hepatitis B or C
Subjects diagnosed with bulimia, binge eating disorder, compulsive overeating, high liquid calorie intake, or similar eating related psychological disorders
Intent to undergo gastric surgery or gastric banding during the study period or within the 6-month period after completion of this study
Prior use of any weight loss gastric medical device such as gastric balloon or gastric aspiration device
Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including: Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus
Known history of any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
Known history of structural or functional disorders of the stomach including, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach or any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety.
Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal (GI) tract
Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
Known history of GI surgeries that may have resulted in anatomical GI tract abnormalities such as a stoma, Nissen Fundoplication or narrowing of any portion of the digestive tract. Examples of these GI surgeries include, but are not limited to, gastric banding; however, uncomplicated appendectomies are acceptable. In addition, known history of any surgeries that may have resulted in anatomical GI tract abnormalities such intestinal adhesions, or any other condition that may inhibit passage through any portion of the GI tract must be excluded
Subjects with Type 1 diabetes or type 2 diabetes
Experienced a myocardial infarction, has a known history of angina, underwent coronary bypass, a known history of congestive heart failure, or is currently being medically treated for any other cardiac condition
Poorly controlled hypertension (≥ 160 mmHg systolic and ≥ 100mmHg diastolic)
End stage renal disease or requiring hemodialysis within the past 6 months
Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
Subjects requiring the use of anti-platelet drugs (except for low dose Aspirin as mentioned above) or other agents affecting the normal clotting of blood
Study subjects must not have a history of substance use disorder (licit or illicit) drug or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).
Study subjects must not have a medical history of sensitivity, intolerance, or toxicity to the investigational product, or agents similar to the investigational product.

Where it is running

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

Full record on ClinicalTrials.gov

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