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

NCT ID: NCT05949593

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-27

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.

Conditions

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Geographic Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Eligible subjects will be randomly assigned to begin treatment in 2:1 ratio to receive the study drug (either Tinlarebant 5 mg or matching placebo)

Study Groups

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LBS-008, Tinlarebant

Group Type EXPERIMENTAL

Tinlarebant

Intervention Type DRUG

5 mg tablet taken orally once a day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets for tinlarebant 5 mg prepared similarly.

Interventions

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Tinlarebant

5 mg tablet taken orally once a day

Intervention Type DRUG

Placebo

Placebo tablets for tinlarebant 5 mg prepared similarly.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belite Bio, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Belite Study Site

Phoenix, Arizona, United States

Site Status

Belite Study Site

Arcadia, California, United States

Site Status

Belite Study Site

Beverly Hills, California, United States

Site Status

Belite Study Site

Huntington Beach, California, United States

Site Status

Belite Study Site

Los Angeles, California, United States

Site Status

Belite Study Site

Palo Alto, California, United States

Site Status

Belite Study Site

San Diego, California, United States

Site Status

Belite Study Site

Lakeland, Florida, United States

Site Status

Belite Study Site

Hagerstown, Maryland, United States

Site Status

Belite Study Site

Saint Louis Park, Minnesota, United States

Site Status

Belite Study Site

Westbury, New York, United States

Site Status

Belite Study Site

Cary, North Carolina, United States

Site Status

Belite Study Site

Durham, North Carolina, United States

Site Status

Belite Study Site

Wake Forest, North Carolina, United States

Site Status

Belite Study Site

Portland, Oregon, United States

Site Status

Belite Study Site

Philadelphia, Pennsylvania, United States

Site Status

Belite Study Site

Sewickley, Pennsylvania, United States

Site Status

Belite Study Site

Germantown, Tennessee, United States

Site Status

Belite Study Site

Abilene, Texas, United States

Site Status

Belite Study Site

Dallas, Texas, United States

Site Status

Belite Study Site

San Antonio, Texas, United States

Site Status

Belite Study Site

Warrenton, Virginia, United States

Site Status

Belite Study Site

Chatswood, New South Wales, Australia

Site Status

Belite Study Site

Strathfield, New South Wales, Australia

Site Status

Belite Study Site

Brisbane, Queensland, Australia

Site Status

Belite Study Site

Adelaide, South Australia, Australia

Site Status

Belite Study Site

East Melbourne, Victoria, Australia

Site Status

Belite Study Site

Crawley, Western Australia, Australia

Site Status

Belite Study Site

Beijing, Beijing Municipality, China

Site Status

Belite Study Site

Chengdu, Sichuan, China

Site Status

Belite Study Site

Beijing, , China

Site Status

Belite Study Site

Beijing, , China

Site Status

Belite Study Site

Guandong, , China

Site Status

Belite Study Site

Zhejiang, , China

Site Status

Belite Study Site

Ostrava, , Czechia

Site Status

Belite Study Site

Prague, , Czechia

Site Status

Belite Study Site

Prague, , Czechia

Site Status

Belite Study Site

Dijon, , France

Site Status

Belite Study Site

Écully, , France

Site Status

Belite Study Site

Lyon, , France

Site Status

Belite Study Site

Marseille, , France

Site Status

Belite Study Site

Basel, , Switzerland

Site Status

Belite Study Site

Lausanne, , Switzerland

Site Status

Belite Study Site

Taichung, , Taiwan

Site Status

Belite Study Site

Taipei, , Taiwan

Site Status

Belite Study Site

Taoyuan District, , Taiwan

Site Status

Belite Study Site

Great Yarmouth, , United Kingdom

Site Status

Belite Study Site

Harrow, , United Kingdom

Site Status

Belite Study Site

London, , United Kingdom

Site Status

Countries

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United States Australia China Czechia France Switzerland Taiwan United Kingdom

Other Identifiers

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LBS-008-CT05

Identifier Type: -

Identifier Source: org_study_id

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