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

NCT05244304 · DRAGON Phase 3Completed

Lead sponsor
Belite Bio, Inc (Industry)
Enrollment
104 (actual)
Start date
28 Mar 2022
Primary completion
4 Aug 2025 (actual)
Study completion
11 Sep 2025
Last update posted
23 Jul 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
2

Interventions

  • Tinlarebant Drug
  • Placebo Drug

Conditions and primary outcome

  • Stargardt Disease 1

Primary outcome

To measure change in atrophic lesion size (definitely decreased autofluorescence, DDAF) by fundus autofluorescence (FAF) photography from baseline (Baseline thru month 24)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT05244304.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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