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Clinical Trials in the UK / NCT05949593
Active, not recruiting Phase 3

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy

NCT05949593 · tracked via the Priya Life Science UK tracker
Sponsor
Belite Bio, Inc
Phase
Phase 3
Started
2023-07-27
Last updated
2026-01-07

Condition(s) studied

Geographic Atrophy

Investigational drug(s) / intervention(s)

Tinlarebant →Placebo

Tinlarebant: 5 mg tablet taken orally once a day

Placebo: Placebo tablets for tinlarebant 5 mg prepared similarly.

Study summary

This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.

Eligibility

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes. * Minimum BCVA is required in the study eye Exclusion Criteria: * The presence of diabetic macular edema or macular disease in either eye. * Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye. * Uncontrolled diagnosed glaucoma in the study eye

Primary outcome measure(s)

  • To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size — From baseline to Month 24]

Trial sites (49)

FacilityCityRegionStatus
Belite Study Site Phoenix Arizona
Belite Study Site Arcadia California
Belite Study Site Beverly Hills California
Belite Study Site Huntington Beach California
Belite Study Site Los Angeles California
Belite Study Site Palo Alto California
Belite Study Site San Diego California
Belite Study Site Lakeland Florida
Belite Study Site Hagerstown Maryland
Belite Study Site Saint Louis Park Minnesota
Belite Study Site Westbury New York
Belite Study Site Cary North Carolina
Belite Study Site Durham North Carolina
Belite Study Site Wake Forest North Carolina
Belite Study Site Portland Oregon
Belite Study Site Philadelphia Pennsylvania
Belite Study Site Sewickley Pennsylvania
Belite Study Site Germantown Tennessee
Belite Study Site Abilene Texas
Belite Study Site Dallas Texas
Belite Study Site San Antonio Texas
Belite Study Site Warrenton Virginia
Belite Study Site Chatswood New South Wales
Belite Study Site Strathfield New South Wales
Belite Study Site Brisbane Queensland
Belite Study Site Adelaide South Australia
Belite Study Site East Melbourne Victoria
Belite Study Site Crawley Western Australia
Belite Study Site Beijing Beijing Municipality
Belite Study Site Chengdu Sichuan
Belite Study Site Beijing China
Belite Study Site Beijing China
Belite Study Site Guandong China
Belite Study Site Zhejiang China
Belite Study Site Ostrava Czechia
Belite Study Site Prague Czechia
Belite Study Site Prague Czechia
Belite Study Site Dijon France
Belite Study Site Écully France
Belite Study Site Lyon France

+ 9 more sites — see the full list on the official registry below.

More Belite Bio, Inc trials in the UK

A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease Active, not recruiting

Other trials for the same condition

Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD Active, not recruiting
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) Recruiting
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) Active, not recruiting
A Study in Adults With Geographic Atrophy Recruiting
A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration 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 NCT05949593 on ClinicalTrials.gov ↗ ← All trials in the UK