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

Last updated: February 12, 2025
Sponsor: Belite Bio, Inc
Overall Status: Active - 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:
November 30, 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

    Active - Recruiting

  • Belite Study Site

    Strathfield, New South Wales 2135
    Australia

    Active - Recruiting

  • Belite Study Site

    Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Belite Study Site

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Belite Study Site

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Belite Study Site

    Crawley, Western Australia 6009
    Australia

    Active - Recruiting

  • Belite Study Site

    Chengdu, Sichuan 610093
    China

    Active - Recruiting

  • Belite Study Site

    Beijing, 10005
    China

    Site Not Available

  • Belite Study Site

    Guandong, 510060
    China

    Active - Recruiting

  • Belite Study Site

    Zhejiang, 325027
    China

    Site Not Available

  • Belite Study Site

    Ostrava, 70852
    Czech Republic

    Active - Recruiting

  • Belite Study Site

    Prague, 14000
    Czech Republic

    Active - Recruiting

  • Belite Study Site

    Praha, 14059
    Czech Republic

    Active - Recruiting

  • Belite Study Site

    Dijon, 21000
    France

    Active - Recruiting

  • Belite Study Site

    Lyon, 69317
    France

    Active - Recruiting

  • Belite Study Site

    Marseille, 130008
    France

    Active - Recruiting

  • Belite Study Site

    Écully, 69130
    France

    Active - Recruiting

  • Belite Study Site

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Belite Study Site

    Lausanne, 1001
    Switzerland

    Active - Recruiting

  • Belite Study Site

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Belite Study Site

    Tainan, 40447
    Taiwan

    Site Not Available

  • Belite Study Site

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Belite Study Site

    Taoyuan, 33305
    Taiwan

    Active - Recruiting

  • Belite Study Site

    Great Yarmouth, NR31 6LA
    United Kingdom

    Active - Recruiting

  • Belite Study Site

    Harrow, HA1 3UJ
    United Kingdom

    Active - Recruiting

  • Belite Study Site

    London, EC1V 2PD
    United Kingdom

    Active - Recruiting

  • Belite Study Site

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Belite Study Site

    Arcadia, California 91007
    United States

    Site Not Available

  • Belite Study Site

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Belite Study Site

    Huntington Beach, California 92467
    United States

    Active - Recruiting

  • Belite Study Site

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Belite Study Site

    Palo Alto, California 94303
    United States

    Active - Recruiting

  • Belite Study Site

    San Diego, California 92093
    United States

    Active - Recruiting

  • Belite Study Site

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Belite Study Site

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Belite Study Site

    St. Louis Park, Minnesota 55416
    United States

    Active - Recruiting

  • Belite Study Site

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Belite Study Site

    Cary, North Carolina 27511
    United States

    Active - Recruiting

  • Belite Study Site

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Belite Study Site

    Wake Forest, North Carolina 27587
    United States

    Active - Recruiting

  • Belite Study Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Belite Study Site

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Belite Study Site

    Sewickley, Pennsylvania 15143
    United States

    Active - Recruiting

  • Belite Study Site

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Belite Study Site

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Belite Study Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Belite Study Site

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Belite Study Site

    Warrenton, Virginia 20186
    United States

    Active - Recruiting

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