Trials / Completed
CompletedNCT03021291
Extension Study of Gelesis100 on Body Weight
An Open-label Study Assessing the Effect of Gelesis100 on Weight Loss and Weight Maintenance in Overweight and Obese Subjects Who Completed the GLOW Study (G-04)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Gelesis, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-01-25
- Primary completion
- 2017-12-08
- Completion
- 2017-12-15
- First posted
- 2017-01-13
- Last updated
- 2018-02-22
Locations
16 sites across 5 countries: United States, Czechia, Denmark, Italy, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03021291. Inclusion in this directory is not an endorsement.