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Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease

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NCT05244304

Sponsored by Belite Bio, Inc (industry) · BLTE — their whole pipeline →.

Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
104actual
Sites
19
Countries
Australia, Belgium, China +8

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
DateFiledBasisWhat it is
Start2022-03-28actualWhen the study began enrolling
Primary completion2025-08-04actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-09-11actualThe whole study's end, after follow-up
First posted2022-02-17actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-23actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Stargardt Disease 1

Interventions

  • Drug: Tinlarebant
  • Drug: Placebo

Primary outcome

what the primary-completion date above is the date OF
To measure change in atrophic lesion size (definitely decreased autofluorescence, DDAF) by fundus autofluorescence (FAF) photography from baseline
measured Baseline thru month 24

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