What is a Clinical Study?
A clinical study, or clinical trial, is a research study 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 studies, watch the videos below.
Understanding Clinical Trials
Understanding Informed Consent
What is the STARLIGHT Study?
STARLIGHT is a clinical study testing the effects of the study drug, GSK4532990, in adults with alcohol-related liver disease (ALD). Researchers want to see if the study 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 study 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 study may help others with similar alcohol-related health problems in the future.
Who can participate?
To be considered for this study, 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 study visits.
It’s also important that you have someone to support you during the study (for example, a spouse, friend, family member, or neighbor).
Additional study criteria apply.
What happens
during the study?
If you qualify, you will be in the study for up to 11 months (less than 1 year). During the study you will have several visits to receive the study 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 study even if you have not stopped drinking.
Informed Consent
Before any study procedures can begin, you will first need to give your consent, or permission, to join the study by reading and signing the Informed Consent Form.
Screening
(up to 3 weeks; 2 visits)
To determine whether you qualify for the study, the study team will ask questions about your health, medical history, and the medicines you take. You will also have a checkup and some tests.
Study Treatment
(up to 24 weeks; up to 11 visits)
If you qualify for the study, you will be placed by chance into a study treatment group to receive:
- The study drug GSK4532990 (active drug)
or
- A placebo (inactive drug)*
*The placebo looks just like the study drug but contains no active medicine. This helps researchers understand the true effects of GSK4532990. Neither you nor the study doctor will know which group you are in. This helps to keep the study fair.
The study 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 study 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 study 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 study, you will have visits to the study 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
