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)

TinlarebantPlacebo

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

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)

Facility	City	Region
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

A Study in Adults With Geographic Atrophy Starting soon

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

Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD Active, not recruiting

Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study Active, not 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

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