A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease
← catalyst calendarNCT06388083 · readout ≤ 559 d
Sponsored by Belite Bio, Inc (industry) · BLTE — their whole pipeline →.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
60estimated
Sites
18
Countries
Japan, United Kingdom, United States
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
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-31 | actual | When the study began enrolling |
| Primary completion | Feb 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-04-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- STGD1
- Stargardt Disease 1
Interventions
- Drug: Tinlarebant — also filed as LBS-008
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFTo measure the annualized rate of change from baseline lesion size in aggregate area of atrophy
measured From baseline to Month 24
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