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

NCT04222322 | Completed FDA Device

• 1 other identifier: PRT-05-031
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• The difference between the percent body weight loss between the active and control groups

  The difference between the percent average body weight loss at 24-weeks post randomization between the active and control groups

  24 weeks

• The proportion of treatment responders in the active group

  The proportion of treatment responders defined as subjects who have lost 5% or more of baseline weight at 24-weeks post randomization, among the active group

  24 weeks

Study Arms (2)

Epitomee Capsule

EXPERIMENTAL

Epitomee Capsule combined with moderate intensity lifestyle counseling

Device: Epitomee Capsule

Control-Placebo

PLACEBO COMPARATOR

Visually matching (to Epitomee capsule) placebo capsule combined with moderate intensity lifestyle counseling

Other: Control-Placebo

Interventions

Epitomee Capsule DEVICE

Arm treatment: Epitomee Capsule combined with moderate intensity lifestyle counseling.

Epitomee Capsule

Control-Placebo OTHER

Arm treatment: Visually matching placebo capsule combined with moderate intensity lifestyle counseling.

Control-Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• % ≤ 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

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

Sponsors & Collaborators

• Epitomee medical: lead

Study Sites (9)

University of Alabama, Dept of Nutrition Sciences

Birmingham, Alabama, 35294, United States

Location

Northwestern University - 645 N. Michigan Avenue, Suite 530

Chicago, Illinois, 60611, United States

Location

The University of Kansas, Department of Internal Medicine

Kansas City, Kansas, 66160, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Pennington Biomedical Research Center , 6400 Perkins Road

Baton Rouge, Louisiana, 70808, United States

Location

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

Winston-Salem, North Carolina, 27101, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

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

Charleston, South Carolina, 29425, United States

Location

Juno Resreach

Houston, Texas, 77040, United States

Location

Related Publications (1)

• Bays HE, Ard JD, O'Neil PM, Wadden TA, Kushner RF, Jakicic JM, Wyatt HR, Greenway FL, Kamar M, Ganon-Elazar E, Asaraf LC, Ryan DH. Weight and cardiometabolic effects of a novel oral shape-shifting superabsorbent hydrogel capsule: Prespecified and exploratory analysis of the Epitomee capsule RESET study. Obes Pillars. 2025 Jan 31;13:100163. doi: 10.1016/j.obpill.2025.100163. eCollection 2025 Mar.

  PMID: 40028615 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yael Kenan, Dr

  Epitomee Medical, VP Clinical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 9, 2020
• Study Start: September 15, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

US (9)