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NCT05949593 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Geographic Atrophy, sponsored by Belite Bio.

Active
Registry status
Phase 3
Development phase
429
Enrollment target
20
Study locations

NCT05949593 is a Phase 3 study of Geographic Atrophy that is active but no longer recruiting, run by Belite Bio. The registered enrollment target is 429 participants, above the 206-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT05949593, a Phase 3 study of Geographic Atrophy, is active but no longer recruiting, sponsored by Belite Bio.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
429 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Geographic Atrophy

Interventions

  • DRUG Placebo
  • DRUG Tinlarebant

Study Locations (20)

California

  • Belite Study Site - Arcadia
  • Belite Study Site - Beverly Hills
  • Belite Study Site - Huntington Beach
  • Belite Study Site - Los Angeles
  • Belite Study Site - Palo Alto
  • Belite Study Site - San Diego

North Carolina

  • Belite Study Site - Cary
  • Belite Study Site - Durham
  • Belite Study Site - Wake Forest

Pennsylvania

  • Belite Study Site - Philadelphia
  • Belite Study Site - Sewickley

Texas

  • Belite Study Site - Abilene
  • Belite Study Site - Dallas

Arizona

  • Belite Study Site - Phoenix

Florida

  • Belite Study Site - Lakeland

Maryland

  • Belite Study Site - Hagerstown

Minnesota

  • Belite Study Site - Saint Louis Park

Trial Details

FieldValue
Enrollment Target 429 participants
Start Date 2023-07-27
Est. Completion 2027-08-31
Phase Phase 3

Sponsor

Belite Bio

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05949593

The ClinicalTrials.gov registry entry for NCT05949593 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 429 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 206-participant average among 27 other Geographic Atrophy trials with a reported enrollment target (108% higher). The listed sponsor is Belite Bio, which has 4 total studies on file at ClinicalTrials.gov.

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

NCT05949593 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, North Carolina, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05949593 about?

NCT05949593 is a clinical study titled "Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy". 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.

What is the current status of trial NCT05949593?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 429 participants. The study started on 2023-07-27. Estimated completion is 2027-08-31.

What conditions does trial NCT05949593 study?

This clinical trial studies the following conditions: Geographic Atrophy.

What interventions are being tested in trial NCT05949593?

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

Who is sponsoring clinical trial NCT05949593?

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

Where is trial NCT05949593 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.