MedTrace Logo

Extension Study of Gelesis100 on Body Weight

NCT03021291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-02-22

No results posted yet for this study

Summary

This study is designed to assess the effect of Gelesis100 on body weight after an additional exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least 3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.

Conditions

  • Overweight and Obesity

Interventions

DEVICE

Gelesis100 (2.25 g)

Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.

Sponsors & Collaborators

  • Gelesis, Inc.

    lead INDUSTRY

Principal Investigators

  • Hassan Heshmati, MD · Gelesis, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-25
Primary Completion
2017-12-08
Completion
2017-12-15
FDA Device
Yes

Countries

  • United States
  • Czechia
  • Denmark
  • Italy
  • Spain

Study Locations

More Related Trials

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 NCT03021291 on ClinicalTrials.gov