A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease

Last updated: March 11, 2026
Sponsor: Belite Bio, Inc
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Geographic Atrophy

Macular Degeneration

Myopic Macular Degeneration

Treatment

Placebo

Tinlarebant

Clinical Study ID

NCT06388083
LBS-008-CT07
  • Ages 12-20
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have clinically diagnosed STGD1 with at least one mutation identifiedin the ABCA4 gene.

  • Subjects must have a defined aggregate atrophic lesion in 1 or both eyes.

  • Minimum BCVA is required in the study eye

Exclusion

Exclusion Criteria:

  • Any ocular disease other than STGD1 that, in the opinion of the investigator, wouldcomplicate assessment of a treatment effect.

  • History of ocular surgery in the study eye in the last 3 months.

  • Any prior gene therapy.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
July 31, 2024
Estimated Completion Date:
February 29, 2028

Study Description

This study will be comprised of a Phase 1b part conducted in Japan and a Phase 2/3 part. The Phase 1b part of the study will be open-label and will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of daily doses of 5 mg tinlarebant, administered for 7 days, in Japanese subjects with Stargardt Disease (STGD1). The Phase 2/3 part of the study will be randomized, double masked, and placebo controlled to evaluate the safety, tolerability, and efficacy of daily doses of 5 mg tinlarebant, administered for 24 months, in subjects with STGD1.

Connect with a study center

  • Belite Study Site

    Kobe,
    Japan

    Site Not Available

  • Belite Study Site

    Kobe 1859171,
    Japan

    Site Not Available

  • Belite Study Site

    Kyoto,
    Japan

    Site Not Available

  • Belite Study Site

    Kyoto 1857910,
    Japan

    Site Not Available

  • Belite Study Site

    Tokyo,
    Japan

    Site Not Available

  • Belite Study Site

    Tokyo 1850147,
    Japan

    Site Not Available

  • Bellite Study Site

    London,
    United Kingdom

    Active - Recruiting

  • UK01 Belite Study Site

    London,
    United Kingdom

    Site Not Available

  • UK01 Belite Study Site

    London 2643743,
    United Kingdom

    Site Not Available

  • Belite Study Site

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Belite Study Site - US08

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Belite Study Site - US08

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Site Not Available

  • Belite Study Site

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Belite Study Site - US05

    La Jolla, California 92093
    United States

    Site Not Available

  • Belite Study Site

    San Diego, California 92037
    United States

    Site Not Available

  • Belite Study Site

    San Francisco, California 94158
    United States

    Site Not Available

  • Belite Study Site - US09

    San Francisco, California 94158
    United States

    Site Not Available

  • Belite Study Site - US05

    La Jolla 5363943, California 5332921 92093
    United States

    Site Not Available

  • Belite Study Site - US09

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Belite Study Site

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Belite Study Site - US06

    Miami, Florida 33136
    United States

    Site Not Available

  • Belite Study Site - US06

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Belite Study Site

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Belite Study Site - US01

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Belite Study Site - US01

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Belite Study Site - US11

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Belite Study Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Belite Study Site - US04

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Belite Study Site - US11

    Edina 5025264, Minnesota 5037779 55435
    United States

    Site Not Available

  • Belite Study Site - US04

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Belite Study Site - US14

    New York, New York 10032
    United States

    Site Not Available

  • Belite Study Site

    Westbury, New York 11590
    United States

    Site Not Available

  • Belite Study Site - US10

    Westbury, New York 11590
    United States

    Site Not Available

  • Belite Study Site - US14

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Belite Study Site - US10

    Westbury 5144040, New York 5128638 11590
    United States

    Site Not Available

  • Belite Study Site

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Belite Study Site - US02

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Belite Study Site - US02

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • Belite Study Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Belite Study Site - US07

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Belite Study Site - US07

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Belite Study Site - US13

    Austin, Texas 78705
    United States

    Site Not Available

  • Belite Study Site

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Belite Study Site - US03

    Dallas, Texas 75231
    United States

    Site Not Available

  • Belite Study Site - US12

    The Woodlands, Texas 77384
    United States

    Site Not Available

  • Belite Study Site - US13

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Belite Study Site - US03

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Belite Study Site - US12

    The Woodlands 4736476, Texas 4736286 77384
    United States

    Site Not Available

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