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ACTIVE NOT RECRUITING Phase 3

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

NCT05949593 · View on ClinicalTrials.gov ↗

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

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

3 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 429 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Belite Bio, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05949593 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, North Carolina, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05949593?

The interventions under investigation include: Placebo (DRUG), Tinlarebant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05949593?

This trial is sponsored by Belite Bio, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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