The Effect of Epitomee Capsule on Body Weight in Patients with Overweight and Obesity with and without Prediabetes

The Effect of Epitomee Capsule on Body Weight in Patients with Overweight and Obesity with and without Prediabetes

Brief description of study

The purpose of the study is to compare the effect of the Epitomee Capsule (EC) to a placebo capsule in in reducing body weight. In addition, both groups will receive lifestyle modification. Epitomee Capsule is an investigational device, and has not been approved by the U.S. Food and Drug Administration (FDA). Epitomee Capsule is an orally taken capsule that contains a small shape-shifting scaffold that works on the stomach itself by direct mechanosensory stimulation (the sense of touch). The capsule helps the body produce an early and continued sense of fullness during and after meals. Epitomee Capsule does not release any chemicals, is not absorbed by the body, and comes out as waste.

Detailed description of study

  • Study participants will be randomly assigned to one of two groups.
  • Half of the participants will be assigned to receive the Epitomee Capsule, and the other half will be assigned to a visually matching placebo. 
  • All participants, regardless of group assignment, will receive the 14 sessions of high-intensity lifestyle counseling over the treatment period of 24 weeks. We believe that lifestyle counseling alone will induce weight loss. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Prediabetes,Overweight,Obesity
  • Age: Between 18 Years - 99 Years
  • Gender: All

Inclusion:
 
  • BMI of 27.0-40.0 kg/m2 inclusive
  • Normoglycemic subjects or subjects with prediabetes
  • Subjects must have access to a primary care provider
  • Previously attempted to lose weight unsuccessfully using a medically supervised or self-directed diet
 
Exclusion:
 
  • 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
  • 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 the study
  • Types 1 or 2 diabetes
 

Updated on 14 Jul 2023. Study ID: 842580

Interested in the study

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