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

January 5, 2026 updated by: Belite Bio, Inc

PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
429

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Chatswood, New South Wales, Australia, 2067
        • Belite Study Site
      • Strathfield, New South Wales, Australia, 2135
        • Belite Study Site
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Belite Study Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Belite Study Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Belite Study Site
    • Western Australia
      • Crawley, Western Australia, Australia, 6009
        • Belite Study Site
  • China
      • Beijing, China, 10005
        • Belite Study Site
      • Beijing, China, 100730
        • Belite Study Site
      • Guandong, China, 510060
        • Belite Study Site
      • Zhejiang, China, 325027
        • Belite Study Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Belite Study Site
    • Sichuan
      • Chengdu, Sichuan, China, 610093
        • Belite Study Site
  • Czechia
      • Ostrava, Czechia, 70852
        • Belite Study Site
      • Prague, Czechia, 14000
        • Belite Study Site
      • Prague, Czechia, 14059
        • Belite Study Site
  • France
      • Dijon, France, 21000
        • Belite Study Site
      • Lyon, France, 69317
        • Belite Study Site
      • Marseille, France, 130008
        • Belite Study Site
      • Écully, France, 69130
        • Belite Study Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Belite Study Site
      • Lausanne, Switzerland, 1001
        • Belite Study Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • Belite Study Site
      • Taipei, Taiwan, 100
        • Belite Study Site
      • Taoyuan District, Taiwan, 33305
        • Belite Study Site
  • United Kingdom
      • Great Yarmouth, United Kingdom, NR31 6LA
        • Belite Study Site
      • Harrow, United Kingdom, HA1 3UJ
        • Belite Study Site
      • London, United Kingdom, EC1V 2PD
        • Belite Study Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Belite Study Site
    • California
      • Arcadia, California, United States, 91007
        • Belite Study Site
      • Beverly Hills, California, United States, 90211
        • Belite Study Site
      • Huntington Beach, California, United States, 92467
        • Belite Study Site
      • Los Angeles, California, United States, 90033
        • Belite Study Site
      • Palo Alto, California, United States, 94303
        • Belite Study Site
      • San Diego, California, United States, 92093
        • Belite Study Site
    • Florida
      • Lakeland, Florida, United States, 33805
        • Belite Study Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Belite Study Site
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Belite Study Site
    • New York
      • Westbury, New York, United States, 11590
        • Belite Study Site
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Belite Study Site
      • Durham, North Carolina, United States, 27710
        • Belite Study Site
      • Wake Forest, North Carolina, United States, 27587
        • Belite Study Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Belite Study Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Belite Study Site
      • Sewickley, Pennsylvania, United States, 15143
        • Belite Study Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Belite Study Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Belite Study Site
      • Dallas, Texas, United States, 75231
        • Belite Study Site
      • San Antonio, Texas, United States, 78240
        • Belite Study Site
    • Virginia
      • Warrenton, Virginia, United States, 20186
        • Belite Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
  • Minimum BCVA is required in the study eye

Exclusion Criteria:

  • The presence of diabetic macular edema or macular disease in either eye.
  • Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
  • Uncontrolled diagnosed glaucoma in the study eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo tablets for tinlarebant 5 mg prepared similarly.
Experimental: LBS-008, Tinlarebant
Drug: Tinlarebant
5 mg tablet taken orally once a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
Time Frame: From baseline to Month 24]
From baseline to Month 24]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale
Time Frame: From baseline to Month 24
From baseline to Month 24
To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)
Time Frame: From baseline to Month 24
From baseline to Month 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
To evaluate the correlation between the reduction of serum RBP4 and the growth of atrophic lesions (DDAF)
Time Frame: From baseline to Month 24
From baseline to Month 24
To measure changes in retinal sensitivity as assessed by microperimetry
Time Frame: From baseline to Month 24
From baseline to Month 24
To measure changes in contrast sensitivity as assessed using the Pelli-Robson Contrast Sensitivity Chart (or any assessment deemed acceptable by study sites)
Time Frame: From baseline to Month 24
From baseline to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Belite Bio, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LBS-008-CT05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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