Trial · NCT05244304
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease
NCT05244304, Phase 3, Completed, Belite Bio, Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease. Trials, record NCT05244304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05244304
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease
- NCT number
- NCT05244304
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 104 participants, actual
- Lead sponsor
- Belite Bio, Inc
- Conditions
- Stargardt Disease 1
- Interventions
- Tinlarebant, Placebo
- First posted
- 2022-02-17
- Last updated
- 2026-07-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To measure change in atrophic lesion size (definitely decreased autofluorescence, DDAF) by fundus autofluorescence (FAF) photography from baseline | Baseline thru month 24 | |
| Secondary | To measure the change in retinal thickness assessed by spectral-domain optical coherence tomography (SD-OCT) from baseline | Baseline thru month 24 | |
| Secondary | To measure the change in retinal morphology assessed by spectral-domain optical coherence tomography (SD-OCT) from baseline | Baseline thru month 24 | |
| Secondary | To measure change in BCVA (Best Corrected Visual Acuity) score measured by the EDTRS method from baseline | Baseline thru month 24 | |
| Secondary | To measure change in plasma concentration of RBP4 levels (μM) from baseline | Baseline thru month 24 | |
| Secondary | The correlation between change in plasma RBP4 level and the rate of lesion size growth (definitely decreased autofluorescence, DDAF) by fundus autofluorescence (FAF) photography from baseline | Baseline thru month 24 | |
| Secondary | To assess the systemic and ocular safety and tolerability of tinlarebant | Baseline thru month 24 | Frequency, duration, and severity of AEs |
| Other | To measure change in total decreased autofluorescence (DAF) by FAF photography from baseline | Baseline thru month 24 | |
| Other | To measure change in questionably decreased autofluorescence (QDAF) by FAF photography from baseline | Baseline thru month 24 | |
| Other | To measure change in quantitative autofluorescence (qAF) level from baseline | Baseline thru month 24 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05244304
GET https://conductscience.org/api/trials/v1/NCT05244304/registered