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NCT06388083 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Stargardt Disease 1 and STGD1, sponsored by Belite Bio.

Active
Registry status
Phase 2
Development phase
60
Enrollment target
18
Study locations

NCT06388083: Active Phase 2 study of Stargardt Disease 1 and STGD1, sponsored by Belite Bio.

NCT06388083 is a Phase 2 study of Stargardt Disease 1 and STGD1 that is active but no longer recruiting, run by Belite Bio. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06388083, a Phase 2 study of Stargardt Disease 1 and STGD1, is active but no longer recruiting, sponsored by Belite Bio.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
18
Study locations

Study Summary

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

Interventions

  • DRUG Placebo
  • DRUG Tinlarebant

Study Locations (18)

Other

  • Belite Study Site - Kobe
  • Belite Study Site - Kyoto
  • Belite Study Site - Tokyo
  • UK01 Belite Study Site - London

Texas

  • Belite Study Site - US13 - Austin
  • Belite Study Site - US03 - Dallas
  • Belite Study Site - US12 - The Woodlands

California

  • Belite Study Site - US05 - La Jolla
  • Belite Study Site - US09 - San Francisco

Minnesota

  • Belite Study Site - US11 - Edina
  • Belite Study Site - US04 - Rochester

New York

  • Belite Study Site - US14 - New York
  • Belite Study Site - US10 - Westbury

Arizona

  • Belite Study Site - US08 - Phoenix

Florida

  • Belite Study Site - US06 - Miami

Massachusetts

  • Belite Study Site - US01 - Boston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-07-31
Est. Completion 2028-02
Phase Phase 2
Belite Bio

4 total trials

What the registry record for NCT06388083 still lists

NCT06388083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

The record links to 2 conditions, with Stargardt Disease 1 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06388083 lists 18 locations in 10 states (Other, Texas, California).

Frequently Asked Questions

What is clinical trial NCT06388083 about?

NCT06388083 is a clinical study titled "A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease". The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease

What is the current status of trial NCT06388083?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-07-31. Estimated completion is 2028-02.

What conditions does trial NCT06388083 study?

This clinical trial studies the following conditions: Stargardt Disease 1, STGD1.

What interventions are being tested in trial NCT06388083?

The interventions under investigation include: Placebo (DRUG), Tinlarebant (DRUG).

Who is sponsoring clinical trial NCT06388083?

This trial is sponsored by Belite Bio, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06388083 being conducted?

This trial has 18 study locations across Arizona, California, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stargardt Disease 1

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06388083's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06388083, the US trial registry maintained by the National Library of Medicine. NCT06388083 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.