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

No results posted yet for this 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.

Conditions

Interventions

DRUG

Tinlarebant

5 mg tablet taken orally once a day

DRUG

Placebo

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949593 on ClinicalTrials.gov