Trials / Unknown
UnknownNCT04887766
Study on GS300 on NAFLD
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS300 on Nonalcoholic Fatty Liver Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- Gelesis, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To determine the efficacy of GS300 when administered for 24 weeks in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
Detailed description
This is a multicenter, randomized, placebo-controlled, double-blinded, parallel-group study. Patients will be randomized 1:1 to receive either GS300 or placebo. The study includes an up to 6 weeks screening period, a 24-week treatment period, and a 1-week follow-up period. Approximately 250 patients (125 patients per arm) will be enrolled (at least 40% from each gender and at least 40% from US and 40% from Europe).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GS300 | Gelesis300 hydrogel in gelatin capsules |
| DEVICE | Placebo | Placebo capsules |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2021-05-14
- Last updated
- 2022-01-24
Source: ClinicalTrials.gov record NCT04887766. Inclusion in this directory is not an endorsement.