MedTrace Logo

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease

NCT05244304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-10-31

No results posted yet for this study

Summary

The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1

Conditions

  • Stargardt Disease 1

Interventions

DRUG

Tinlarebant

Tinlarebant drug substance is a white to off-white substance and is dispensed as a tablet for oral administration.

DRUG

Placebo

Not active drug

Sponsors & Collaborators

  • Belite Bio, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2025-08-04
Completion
2025-09-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • China
  • France
  • Germany
  • Hong Kong
  • Netherlands
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05244304 on ClinicalTrials.gov