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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Geographic Atrophy

In brief

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.

Key facts

Study ID

NCT05949593

Run by

Belite Bio, Inc

People needed

429

Starts

2023-07-27

Expected to finish

2027-08-31

Last updated by the study team

2026-01-07

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
• Minimum BCVA is required in the study eye

You may not qualify if…

• 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

Where it is running

• Belite Study Site — Phoenix, Arizona, United States
• Belite Study Site — Arcadia, California, United States
• Belite Study Site — Beverly Hills, California, United States
• Belite Study Site — Huntington Beach, California, United States
• Belite Study Site — Los Angeles, California, United States
• Belite Study Site — Palo Alto, California, United States
• Belite Study Site — San Diego, California, United States
• Belite Study Site — Lakeland, Florida, United States
• Belite Study Site — Hagerstown, Maryland, United States
• Belite Study Site — Saint Louis Park, Minnesota, United States
• Belite Study Site — Westbury, New York, United States
• Belite Study Site — Cary, North Carolina, United States
• Belite Study Site — Durham, North Carolina, United States
• Belite Study Site — Wake Forest, North Carolina, United States
• Belite Study Site — Portland, Oregon, United States
• Belite Study Site — Philadelphia, Pennsylvania, United States
• Belite Study Site — Sewickley, Pennsylvania, United States
• Belite Study Site — Germantown, Tennessee, United States
• Belite Study Site — Abilene, Texas, United States
• Belite Study Site — Dallas, Texas, United States
• Belite Study Site — San Antonio, Texas, United States
• Belite Study Site — Warrenton, Virginia, United States
• Belite Study Site — Chatswood, New South Wales, Australia
• Belite Study Site — Strathfield, New South Wales, Australia
• Belite Study Site — Brisbane, Queensland, Australia

Full record on ClinicalTrials.gov

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