Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes
← catalyst calendarSponsored by Fractyl Health Inc. (industry) · GUTS — their whole pipeline →.
Phase
Not applicable
Status
Suspended
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
320estimated
Sites
58
Countries
Belgium, Ireland, Italy +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Enrollment pause
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-03-08 | actual | When the study began enrolling |
| Primary completion | Jan 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2020-06-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Type 2 Diabetes
Interventions
- Device: Duodenal Mucosal Resurfacing (DMR)
- Device: Duodenal Mucosal Resurfacing (Sham)
Primary outcome
what the primary-completion date above is the date OFDemonstrate superiority of Revita DMR to sham in improving glycemic control
measured Baseline to Week 24
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