What is a Clinical Trial?
A clinical trial, or clinical trial, is a research trial that helps doctors and scientists learn more about a disease or medical condition and new ways to treat, diagnose, or prevent it. To learn more about clinical trials, watch the videos below.
Understanding Clinical Trials
Understanding Informed Consent
What is the STARLIGHT Trial?
STARLIGHT is a clinical trial testing the effects of the trial drug, GSK4532990, in adults with alcohol-related liver disease (ALD). Researchers want to see if the trial drug can improve ALD and if it’s safe and well-tolerated.
In ALD, damage to the liver caused by heavy alcohol drinking worsens over time. A certain protein made in the liver is thought to be involved in the development and worsening of ALD. The trial drug works by lowering the amount of this protein, which may reduce the harmful effects of alcohol on the liver.
Your participation is highly valued. Information learned from this trial may help others with similar alcohol-related health problems in the future.
Who can participate?
To be considered for this trial, you must:
- Be 18 to 65 years of age.
- Have alcohol-related liver disease.
- Have drunk alcohol within the last 4 months.
- Agree to attend scheduled trial visits.
It’s also important that you have someone to support you during the trial (for example, a spouse, friend, family member, or neighbour).
Additional trial criteria apply.
What happensduring the trial?
If you qualify, you will be in the trial for up to 16.5 months.
During the trial you will have several visits to receive the trial treatment and to have health checks and tests.
Stopping alcohol drinking is recommended for people living with liver disease. However, this may not always be possible. You will still be able to participate in this trial even if you have not stopped drinking.
Informed Consent
Before any trial procedures can begin, you will first need to give your consent, or permission, to join the trial by reading and signing the Informed Consent Form.
Screening
(up to 4 weeks; 2 visits)
To determine whether you qualify for the trial, the trial team will ask questions about your health, medical history, and the medicines you take. You will also have a checkup and some tests.
Trial Treatment
(up to 48 weeks, up to 17 visits)
If you qualify for the trial, you will be placed by chance into a trial treatment group to receive:
- The trial drug GSK4532990 (active drug)
or
- A placebo (inactive drug)*
*The placebo looks just like the trial drug but contains no active medicine. This helps researchers understand the true effects of GSK4532990. Neither you nor the trial doctor will know which group you are in. This helps to keep the trial fair.
The trial treatment is given as 2 injections (shots) into the skin every 4 weeks.
You will also have visits with tests to check on your health and to see how the trial treatment may be affecting you. Certain visits may take place at home or at a clinic closer to home.
Follow-up
(18 weeks; 3 visits)
After completing the trial treatment, you will have a few more visits to check on your health.
What kind of health checks and tests can I expect?
During the trial, you will have visits to the trial site for health checks and tests. You will not have every test at each visit.
Physical exam
Height/Weight
Vital signs
Heart activity (ECG)
Liver imaging
Blood tests
Urine test
Pregnancy test (if needed)
Hair sample testing (if possible)
Injection site check
Questionnaires
ECG = electrocardiogram.
There may be some additional tests that are optional.
Spleen imaging
Liver biopsy
Additional blood and DNA tests
