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A study to evaluate the safety and tolerability of tinlarebant in patients with Stargardt disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Stargardt Disease, which is a rare genetic condition that causes progressive loss of vision. The research aims to evaluate the long-term safety and how well the body tolerates a medication called tinlarebant, also known as LBS-008. This medication is administered as an oral tablet.

Participants in this long-term study will take the medication over a period of three years. During this time, the effects of the treatment on the body and the eyes will be monitored to ensure it is safe for continued use.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    A tablet containing 5 mg of tinlarebant is taken by oral use.

  2. Step 2

    Study monitoring

    The safety and how well the body tolerates the tinlarebant is monitored over a period of 3 years.

    Changes in autofluorescence, which is a specialized type of eye photography used to look at the health of the retina, are assessed to track the effects of the medication.

Who can join the trial?

5 criteria

  • You must have Stargardt Disease, which is a rare condition that affects the vision.
  • You must have already finished a 24-month treatment period in one of two previous studies, known as LBS-008-CT02 or LBS-008-CT03.
  • You must have finished all necessary medical tests and check-ups required at the end of your previous treatment period.
  • The study is open to both males and females.
  • The study is open to people within the specific age ranges defined by the study protocols.

Who cannot join the trial?

12 criteria

  • If you have had eye surgery on the eye being studied within the last 3 months.
  • If you are unwilling or unable to provide informed consent, which is a signed document where you agree to participate after understanding the study details.
  • If the investigator (the main doctor in charge of the study) decides that you are not a suitable candidate for the trial.
  • If you use prescription medicines like Isotretinoin or other substances that affect retinol (a form of Vitamin A) which could interfere with how the study drug works.
  • If you have used medicines or supplements that affect cytochrome P450 (CYP) enzymes (proteins in the body that help break down drugs) within 30 days, such as rifampin or St. John’s wort.
  • If you have eaten foods that affect certain enzymes (proteins that help with chemical reactions in the body) like grapefruit, bitter orange, pomegranate, or star fruit within 48 hours of taking the study drug.
  • If you have a life-threatening disease, such as an active malignancy (cancer).
  • If there is current alcohol or substance abuse.
  • If your ALT or AST levels (enzymes that show how well your liver is working) are more than 2.5 times higher than the upper limit of normal (the standard healthy range).
  • If you have renal insufficiency, which means your kidneys are not working well enough, measured by an eGFR (a calculation used to check kidney function) of less than 30.
  • If you are pregnant or nursing, or if you are a female of childbearing potential (able to become pregnant) and are unwilling to use effective contraception (birth control) or practice abstinence.
  • If a male participant does not agree that a female partner will use effective contraception or is unable to have children.
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Investigated drugs

Tinlarebant is an oral tablet being studied to see how safe it is to use over a long period for people with Stargardt disease.

What is already known about the treatment

Tinlarebant - This medication is taken as a pill by mouth and is currently being studied in clinical trials to see how safe it is for long-term use. It is used to treat Stargardt disease, a rare condition that causes vision loss. This drug works by lowering the levels of certain fats in the body that can build up and damage the cells in the eye. It belongs to a group of medicines known as retinoid metabolism modulators.

Investigated diseases

Stargardt disease - This is a genetic eye disorder that affects the retina, which is the light-sensitive tissue at the back of the eye. It primarily involves the buildup of fatty substances in the retinal cells. As the condition progresses, these deposits interfere with the cells' ability to function properly. This process leads to a gradual loss of central vision. The damage typically starts in the macula, the area of the retina responsible for sharp, detailed sight. Over time, the area of affected retinal tissue may expand.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522460-33-00Protocol codeLBS-008-CT08Estimated enrolment66 patientsSponsorBelite Bio Inc.

sourced from the EU Clinical Trials Register and site verification

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