Geographic AtrophyPhase 3PHOENIXNCT05949593
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
A Phase 3 study testing Tinlarebant in people with Geographic Atrophy, run by Belite Bio, Inc at 49 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- Tinlarebant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 429 participants
- Where
- 49 sitesin 8 countries
- Study dates
- 27 Jul 2023to 31 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
- Minimum BCVA is required in the study eye
Who cannot join
- 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
Trial locations and contacts
49 sites in 8 countries.
49 sites in 8 countries
United States22 sites
Belite Study Site
Abilene, Texas, 79606
Belite Study Site
Arcadia, California, 91007
Belite Study Site
Beverly Hills, California, 90211
Belite Study Site
Cary, North Carolina, 27511
Belite Study Site
Dallas, Texas, 75231
Belite Study Site
Durham, North Carolina, 27710
Belite Study Site
Germantown, Tennessee, 38138
Belite Study Site
Hagerstown, Maryland, 21740
Belite Study Site
Huntington Beach, California, 92467
Belite Study Site
Lakeland, Florida, 33805
Belite Study Site
Los Angeles, California, 90033
Belite Study Site
Palo Alto, California, 94303
Belite Study Site
Philadelphia, Pennsylvania, 19107
Belite Study Site
Phoenix, Arizona, 85020
Belite Study Site
Portland, Oregon, 97239
Belite Study Site
Saint Louis Park, Minnesota, 55416
Belite Study Site
San Antonio, Texas, 78240
Belite Study Site
San Diego, California, 92093
Belite Study Site
Sewickley, Pennsylvania, 15143
Belite Study Site
Wake Forest, North Carolina, 27587
Belite Study Site
Warrenton, Virginia, 20186
Belite Study Site
Westbury, New York, 11590
Australia6 sites
Belite Study Site
Adelaide, South Australia, 5000
Belite Study Site
Brisbane, Queensland, 4101
Belite Study Site
Chatswood, New South Wales, 2067
Belite Study Site
Crawley, Western Australia, 6009
Belite Study Site
East Melbourne, Victoria, 3002
Belite Study Site
Strathfield, New South Wales, 2135
China6 sites
Belite Study Site
Beijing, Beijing Municipality, 100044
Belite Study Site
Beijing, 10005
Belite Study Site
Beijing, 100730
Belite Study Site
Chengdu, Sichuan, 610093
Belite Study Site
Guandong, 510060
Belite Study Site
Zhejiang, 325027
France4 sites
Belite Study Site
Dijon, 21000
Belite Study Site
Écully, 69130
Belite Study Site
Lyon, 69317
Belite Study Site
Marseille, 130008
Czechia3 sites
Belite Study Site
Ostrava, 70852
Belite Study Site
Prague, 14000
Belite Study Site
Prague, 14059
Taiwan3 sites
Belite Study Site
Taichung, 40447
Belite Study Site
Taipei, 100
Belite Study Site
Taoyuan, 33305
United Kingdom3 sites
Belite Study Site
Great Yarmouth, NR31 6LA
Belite Study Site
Harrow, HA1 3UJ
Belite Study Site
London, EC1V 2PD
Switzerland2 sites
Belite Study Site
Basel, 4031
Belite Study Site
Lausanne, 1001
About this study
Official title: 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.
Read the 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.
- Conditions
- Geographic Atrophy
- Being tested
- Tinlarebant, Placebo
- Keywords
- LBS-008, Tinlarebant, GA
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TinlarebantDrug
5 mg tablet taken orally once a day
PlaceboDrug
Placebo tablets for tinlarebant 5 mg prepared similarly.
| Study group | Role | What they receive |
|---|---|---|
| LBS-008, Tinlarebant | Experimental | Not described Receives: Drug: Tinlarebant |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
Measured: From baseline to Month 24]
Secondary outcomes (2)
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale
Measured: 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)
Measured: From baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start27 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 429 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belite Bio, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949593
- Sponsor's protocol ID
- LBS-008-CT05
- Acronym
- PHOENIX
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05949593
- Acronym / sponsor ID
- PHOENIX / LBS-008-CT05
- Conditions
- Geographic Atrophy
- Keywords
- LBS-008, Tinlarebant, GA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 429 participants (estimated)
- Lead sponsor
- Belite Bio, IncIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBS-008, Tinlarebant | Experimental | Drug: Tinlarebant |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
- Minimum BCVA is required in the study eye
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinlarebant5 mg tablet taken orally once a day | Drug | LBS-008, Tinlarebant |
| PlaceboPlacebo tablets for tinlarebant 5 mg prepared similarly. | Drug | Placebo |
Primary outcome
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
Time frame: From baseline to Month 24]
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tinlarebant in people with Geographic Atrophy, run by Belite Bio, Inc at 49 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Australia, China, France, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size (time frame: From baseline to Month 24]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.