Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
NCT05949593 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 429
Last updated 2026-01-07
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.
Conditions
Interventions
- DRUG
-
Tinlarebant
5 mg tablet taken orally once a day
- DRUG
-
Placebo tablets for tinlarebant 5 mg prepared similarly.
Sponsors & Collaborators
-
Belite Bio, Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-27
- Primary Completion
- 2027-06-30
- Completion
- 2027-08-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- China
- Czechia
- France
- Switzerland
- Taiwan
- United Kingdom
Study Locations
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