A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease

NCT06388083 · tracked via the Priya Life Science UK tracker

Sponsor

Belite Bio, Inc

Phase

Phase 2/3

Started

2024-07-31

Last updated

2026-03-12

Condition(s) studied

STGD1Stargardt Disease 1

Investigational drug(s) / intervention(s)

TinlarebantPlacebo

Tinlarebant: 5 mg tablet

Placebo: Placebo tablets

Study summary

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease

Eligibility

Sex

ALL

Min age

12 Years

Max age

20 Years

Healthy volunteers

Inclusion Criteria: * Subjects must have clinically diagnosed STGD1 with at least one mutation identified in the ABCA4 gene. * Subjects must have a defined aggregate atrophic lesion in 1 or both eyes. * Minimum BCVA is required in the study eye Exclusion Criteria: * Any ocular disease other than STGD1 that, in the opinion of the investigator, would complicate assessment of a treatment effect. * History of ocular surgery in the study eye in the last 3 months. * Any prior gene therapy.

Primary outcome measure(s)

To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy — From baseline to Month 24

Trial sites (18)

Facility	City	Region
Belite Study Site - US08	Phoenix	Arizona
Belite Study Site - US05	La Jolla	California
Belite Study Site - US09	San Francisco	California
Belite Study Site - US06	Miami	Florida
Belite Study Site - US01	Boston	Massachusetts
Belite Study Site - US11	Edina	Minnesota
Belite Study Site - US04	Rochester	Minnesota
Belite Study Site - US14	New York	New York
Belite Study Site - US10	Westbury	New York
Belite Study Site - US02	Durham	North Carolina
Belite Study Site - US07	Philadelphia	Pennsylvania
Belite Study Site - US13	Austin	Texas
Belite Study Site - US03	Dallas	Texas
Belite Study Site - US12	The Woodlands	Texas
Belite Study Site	Kobe	Japan
Belite Study Site	Kyoto	Japan
Belite Study Site	Tokyo	Japan
UK01 Belite Study Site	London	United Kingdom

More Belite Bio, Inc trials in the UK

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy Active, not recruiting

Other trials for the same condition

An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06388083 on ClinicalTrials.gov ↗ ← All trials in the UK