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A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease
Sponsor: Belite Bio, Inc
Summary
The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease
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
Key Details
Gender
All
Age Range
12 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-07-31
Completion Date
2028-02
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Tinlarebant
5 mg tablet
Placebo
Placebo tablets
Locations (18)
Belite Study Site - US08
Phoenix, Arizona, United States
Belite Study Site - US05
La Jolla, California, United States
Belite Study Site - US09
San Francisco, California, United States
Belite Study Site - US06
Miami, Florida, United States
Belite Study Site - US01
Boston, Massachusetts, United States
Belite Study Site - US11
Edina, Minnesota, United States
Belite Study Site - US04
Rochester, Minnesota, United States
Belite Study Site - US14
New York, New York, United States
Belite Study Site - US10
Westbury, New York, United States
Belite Study Site - US02
Durham, North Carolina, United States
Belite Study Site - US07
Philadelphia, Pennsylvania, United States
Belite Study Site - US13
Austin, Texas, United States
Belite Study Site - US03
Dallas, Texas, United States
Belite Study Site - US12
The Woodlands, Texas, United States
Belite Study Site
Kobe, Japan
Belite Study Site
Kyoto, Japan
Belite Study Site
Tokyo, Japan
UK01 Belite Study Site
London, United Kingdom