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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 60 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-07-27

Primary completion: 2027-08-31

Study completion finish: 2027-11-30

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05949593

Intervention or treatment

DRUG: Tinlarebant

DRUG: Placebo

Conditions

• Geographic Atrophy

Condition: Geographic Atrophy
DRUG: Tinlarebant and other drugs
Chatswood, New South Wales, Australia and more
Sponsor: Belite Bio, Inc

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Belite Study Site

Research sites nearby

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Belite Study Site
Chatswood, New South Wales, Australia
Belite Study Site
Strathfield, New South Wales, Australia
Belite Study Site
Brisbane, Queensland, Australia
Belite Study Site
Adelaide, South Australia, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: LBS-008, Tinlarebant Not Specified	DRUG: Tinlarebant 5 mg tablet taken orally once a day
PLACEBO_COMPARATOR: Placebo Not Specified	DRUG: Placebo Placebo tablets for tinlarebant 5 mg prepared similarly.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size	Not Specified	From baseline to Month 24]

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale	Not Specified	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)	Not Specified	From baseline to Month 24

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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