A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease
Public ClinicalTrials.gov record NCT06388083. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Tinlarebant in Japanese Subjects With Stargardt Disease and a Phase 2/3 Randomized, Double-masked, and Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Tinlarebant in Subjects With Stargardt Disease
Study identification
- NCT ID
- NCT06388083
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Belite Bio, Inc
- Industry
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Interventions
- Tinlarebant Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 20 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2024
- Primary completion
- Jan 31, 2028
- Completion
- Jan 31, 2028
- Last update posted
- Mar 11, 2026
2024 – 2028
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Belite Study Site - US08 | Phoenix | Arizona | 85020 | — |
| Belite Study Site - US05 | La Jolla | California | 92093 | — |
| Belite Study Site - US09 | San Francisco | California | 94158 | — |
| Belite Study Site - US06 | Miami | Florida | 33136 | — |
| Belite Study Site - US01 | Boston | Massachusetts | 02115 | — |
| Belite Study Site - US11 | Edina | Minnesota | 55435 | — |
| Belite Study Site - US04 | Rochester | Minnesota | 55905 | — |
| Belite Study Site - US14 | New York | New York | 10032 | — |
| Belite Study Site - US10 | Westbury | New York | 11590 | — |
| Belite Study Site - US02 | Durham | North Carolina | 27705 | — |
| Belite Study Site - US07 | Philadelphia | Pennsylvania | 19107 | — |
| Belite Study Site - US13 | Austin | Texas | 78705 | — |
| Belite Study Site - US03 | Dallas | Texas | 75231 | — |
| Belite Study Site - US12 | The Woodlands | Texas | 77384 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06388083, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 11, 2026 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06388083 live on ClinicalTrials.gov.