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

NCT04222322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2024-03-19

No results posted yet for this study

Summary

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

Conditions

  • Overweight and Obesity

Interventions

DEVICE

Epitomee Capsule

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

OTHER

Control-Placebo

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

Sponsors & Collaborators

  • Epitomee medical

    lead INDUSTRY

Principal Investigators

  • Yael Kenan, Dr · Epitomee Medical, VP Clinical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2023-12-30
Completion
2023-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04222322 on ClinicalTrials.gov