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

Last updated: January 5, 2026
Sponsor: Belite Bio, Inc
Overall Status: Active - Not Recruiting

Phase

3

Condition

Geographic Atrophy

Treatment

Tinlarebant

Placebo

Clinical Study ID

NCT05949593
LBS-008-CT05
  • Ages 60-85
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or botheyes.

  • Minimum BCVA is required in the study eye

Exclusion

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

Study Design

Total Participants: 429
Treatment Group(s): 2
Primary Treatment: Tinlarebant
Phase: 3
Study Start date:
July 27, 2023
Estimated Completion Date:
August 31, 2027

Study Description

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.

Connect with a study center

  • Belite Study Site

    Chatswood, New South Wales 2067
    Australia

    Site Not Available

  • Belite Study Site

    Strathfield, New South Wales 2135
    Australia

    Site Not Available

  • Belite Study Site

    Chatswood 2171707, New South Wales 2155400 2067
    Australia

    Site Not Available

  • Belite Study Site

    Strathfield 2148088, New South Wales 2155400 2135
    Australia

    Site Not Available

  • Belite Study Site

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Belite Study Site

    Brisbane 2174003, Queensland 2152274 4101
    Australia

    Site Not Available

  • Belite Study Site

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Belite Study Site

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Site Not Available

  • Belite Study Site

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Belite Study Site

    East Melbourne 6952201, Victoria 2145234 3002
    Australia

    Site Not Available

  • Belite Study Site

    Crawley, Western Australia 6009
    Australia

    Site Not Available

  • Belite Study Site

    Crawley 10041014, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Belite Study Site

    Chengdu, Sichuan 610093
    China

    Site Not Available

  • Belite Study Site

    Chengdu 1815286, Sichuan 1794299 610093
    China

    Site Not Available

  • Belite Study Site

    Beijing, 100730
    China

    Site Not Available

  • Belite Study Site

    Beijing 1816670, 10005
    China

    Site Not Available

  • Belite Study Site

    Guandong, 510060
    China

    Site Not Available

  • Belite Study Site

    Guandong 8361304, 510060
    China

    Site Not Available

  • Belite Study Site

    Zhejiang, 325027
    China

    Site Not Available

  • Belite Study Site

    Zhejiang 10005239, 325027
    China

    Site Not Available

  • Belite Study Site

    Ostrava, 70852
    Czech Republic

    Site Not Available

  • Belite Study Site

    Prague, 14000
    Czech Republic

    Site Not Available

  • Belite Study Site

    Praha, 14059
    Czech Republic

    Site Not Available

  • Belite Study Site

    Ostrava 3068799, 70852
    Czechia

    Site Not Available

  • Belite Study Site

    Prague 3067696, 14000
    Czechia

    Site Not Available

  • Belite Study Site

    Dijon, 21000
    France

    Site Not Available

  • Belite Study Site

    Dijon 3021372, 21000
    France

    Site Not Available

  • Belite Study Site

    Lyon, 69317
    France

    Site Not Available

  • Belite Study Site

    Lyon 2996944, 69317
    France

    Site Not Available

  • Belite Study Site

    Marseille, 130008
    France

    Site Not Available

  • Belite Study Site

    Marseille 2995469, 130008
    France

    Site Not Available

  • Belite Study Site

    Écully, 69130
    France

    Site Not Available

  • Belite Study Site

    Écully 3020392, 69130
    France

    Site Not Available

  • Belite Study Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Belite Study Site

    Basel 2661604, 4031
    Switzerland

    Site Not Available

  • Belite Study Site

    Lausanne, 1001
    Switzerland

    Site Not Available

  • Belite Study Site

    Lausanne 2659994, 1001
    Switzerland

    Site Not Available

  • Belite Study Site

    Taichung, 40447
    Taiwan

    Site Not Available

  • Belite Study Site

    Taichung 1668399, 40447
    Taiwan

    Site Not Available

  • Belite Study Site

    Tainan, 40447
    Taiwan

    Site Not Available

  • Belite Study Site

    Taipei, 100
    Taiwan

    Site Not Available

  • Belite Study Site

    Taipei 1668341, 100
    Taiwan

    Site Not Available

  • Belite Study Site

    Taoyuan, 33305
    Taiwan

    Site Not Available

  • Belite Study Site

    Taoyuan District 1667905, 33305
    Taiwan

    Site Not Available

  • Belite Study Site

    Great Yarmouth, NR31 6LA
    United Kingdom

    Site Not Available

  • Belite Study Site

    Great Yarmouth 2647984, NR31 6LA
    United Kingdom

    Site Not Available

  • Belite Study Site

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

  • Belite Study Site

    Harrow 2647425, HA1 3UJ
    United Kingdom

    Site Not Available

  • Belite Study Site

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Belite Study Site

    London 2643743, EC1V 2PD
    United Kingdom

    Site Not Available

  • Belite Study Site

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Belite Study Site

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Site Not Available

  • Belite Study Site

    Arcadia, California 91007
    United States

    Site Not Available

  • Belite Study Site

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Belite Study Site

    Huntington Beach, California 92467
    United States

    Site Not Available

  • Belite Study Site

    Los Angeles, California 90033
    United States

    Site Not Available

  • Belite Study Site

    Palo Alto, California 94303
    United States

    Site Not Available

  • Belite Study Site

    San Diego, California 92093
    United States

    Site Not Available

  • Belite Study Site

    Arcadia 5324477, California 5332921 91007
    United States

    Site Not Available

  • Belite Study Site

    Beverly Hills 5328041, California 5332921 90211
    United States

    Site Not Available

  • Belite Study Site

    Huntington Beach 5358705, California 5332921 92467
    United States

    Site Not Available

  • Belite Study Site

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Belite Study Site

    Palo Alto 5380748, California 5332921 94303
    United States

    Site Not Available

  • Belite Study Site

    San Diego 5391811, California 5332921 92093
    United States

    Site Not Available

  • Belite Study Site

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Belite Study Site

    Lakeland 4161438, Florida 4155751 33805
    United States

    Site Not Available

  • Belite Study Site

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Belite Study Site

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Site Not Available

  • Belite Study Site

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Belite Study Site

    Saint Louis Park 5045021, Minnesota 5037779 55416
    United States

    Site Not Available

  • Belite Study Site

    Westbury, New York 11590
    United States

    Site Not Available

  • Belite Study Site

    Westbury 5144040, New York 5128638 11590
    United States

    Site Not Available

  • Belite Study Site

    Cary, North Carolina 27511
    United States

    Site Not Available

  • Belite Study Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Belite Study Site

    Wake Forest, North Carolina 27587
    United States

    Site Not Available

  • Belite Study Site

    Cary 4459467, North Carolina 4482348 27511
    United States

    Site Not Available

  • Belite Study Site

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Belite Study Site

    Wake Forest 4497290, North Carolina 4482348 27587
    United States

    Site Not Available

  • Belite Study Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Belite Study Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Belite Study Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Belite Study Site

    Sewickley, Pennsylvania 15143
    United States

    Site Not Available

  • Belite Study Site

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Belite Study Site

    Sewickley 5211506, Pennsylvania 6254927 15143
    United States

    Site Not Available

  • Belite Study Site

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Belite Study Site

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • Belite Study Site

    Abilene, Texas 79606
    United States

    Site Not Available

  • Belite Study Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Belite Study Site

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Belite Study Site

    Abilene 4669635, Texas 4736286 79606
    United States

    Site Not Available

  • Belite Study Site

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Belite Study Site

    San Antonio 4726206, Texas 4736286 78240
    United States

    Site Not Available

  • Belite Study Site

    Warrenton, Virginia 20186
    United States

    Site Not Available

  • Belite Study Site

    Warrenton 4792255, Virginia 6254928 20186
    United States

    Site Not Available

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