Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Tinlarebant for Treating Stargardt Disease in Adolescents

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying Stargardt Disease, a genetic eye disorder that affects vision, particularly in adolescents. The study is testing a treatment called Tinlarebant, also known by its code name LBS-008. This medication is taken in the form of a tablet. The purpose of the study is to evaluate how effective Tinlarebant is in slowing down the progression of vision loss in young people with Stargardt Disease.

Participants in the study will be randomly assigned to receive either Tinlarebant or a placebo. The study is designed to be "double-masked," meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are unbiased. The study will take place over a period of time, during which participants will have regular check-ups to monitor their eye health and any changes in their vision.

The main goal of the study is to see if Tinlarebant can slow the growth of areas in the eye that are losing function, known as atrophic lesions. These areas are monitored using a special type of eye photography called FAF (fundus autofluorescence). Additionally, the study will look at changes in the thickness and structure of the retina, the part of the eye that is crucial for vision, using a method called SDOCT (spectral-domain optical coherence tomography). The study aims to provide valuable information on the safety and effectiveness of Tinlarebant for treating Stargardt Disease in adolescents.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's purpose and procedures. Consent must be provided by the participant and their parent or legal guardian.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the diagnosis of Stargardt Disease and to ensure eligibility. This includes genetic testing for mutations in the ABCA4 gene and imaging of the eye to measure the size of atrophic lesions.

  3. Step 3

    Randomization

    Participants will be randomly assigned to receive either Tinlarebant or a placebo. This process is double-masked, meaning neither the participant nor the study team will know which treatment is being administered.

  4. Step 4

    Medication administration

    Participants will take the assigned medication orally. The medication is in tablet form, with a dosage of 5 mg. The frequency and duration of administration will be specified in the study protocol.

  5. Step 5

    Regular follow-up visits

    Regular follow-up visits will be scheduled to monitor the participant's health and the effects of the medication. These visits will include eye examinations and imaging to assess changes in the atrophic lesions.

  6. Step 6

    End of study

    The study is expected to conclude by September 19, 2025. At the end of the study, a final assessment will be conducted to evaluate the overall effects of the treatment.

Who can join the trial?

4 criteria

  • Participants must be **male or female** and between **12 to 20 years old**.
  • Participants must have a **clinical diagnosis** of **Stargardt Disease (STGD1)**, which is a genetic eye condition, with at least **one mutation** found in the **ABCA4 gene**.
  • Participants must have a specific **size of the affected area** in the eye, which should be within **3 disc areas (7.62 mm²)**, as seen in a special eye image called **FAF**. They must also have a **visual acuity** of **20/200 or better** in the study eye, which means they can see at a certain level of clarity.
  • Participants and their **parent(s) or legal guardian** must agree to sign a **consent form** approved by an ethics committee before starting any study-related activities.

Who cannot join the trial?

7 criteria

  • Patients who have any other eye disease that could affect the study results.
  • Patients who have had eye surgery in the last 3 months.
  • Patients who are currently taking medications that could interfere with the study treatment.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have any serious health condition that could affect their ability to participate in the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Tinlarebant is being studied to see if it can help slow down the progression of Stargardt Disease, a genetic eye disorder that affects young people. The trial aims to determine if this medication can reduce the growth of damaged areas in the retina, which is crucial for maintaining vision.

What is already known about the treatment

Tinlarebant – Tinlarebant is administered orally and is currently being studied in a Phase 3 clinical trial for its potential use in treating Stargardt Disease, a genetic eye disorder. The medication is not yet widely recognized in medical literature as it is still under investigation. Its primary therapeutic indication is to slow the progression of atrophic lesions in adolescents with Stargardt Disease. At the molecular level, Tinlarebant works by inhibiting the formation of toxic byproducts in the retina, which are believed to contribute to the degeneration of retinal cells. It is classified pharmacologically as a retinal protective agent.

Investigated diseases

Stargardt Disease – Stargardt Disease is a genetic eye disorder that typically begins in childhood or adolescence. It is characterized by progressive vision loss due to the degeneration of the macula, a small area in the center of the retina responsible for sharp, central vision. As the disease progresses, individuals may experience difficulty with tasks that require detailed vision, such as reading or recognizing faces. The condition is caused by mutations in the ABCA4 gene, leading to the accumulation of toxic substances in the retina. Over time, this accumulation results in the formation of atrophic lesions, which further impair vision. The progression of vision loss can vary, but it generally leads to significant visual impairment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513483-26-00Protocol codeLBS-008-CT03Estimated enrolment105 patientsSponsorBelite Bio Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.