Liver Disease Research Study
About the “ALLSTAR” Study
The purpose of this study is to find out whether a study medicine called efimosfermin alfa can help adults with alcohol-related liver disease. Researchers also want to learn how safe the medicine is and how well people tolerate it.
Alcohol-related liver disease, or ALD, is liver disease caused mainly by alcohol use. A person does not have to be addicted to alcohol to be at risk; regularly drinking more than the recommended limits can also cause liver damage.
What Will Participants Receive:
- No-cost study related care
- Qualified participants may receive compensation for their travel
You May Qualify If You:
You May Qualify If You:
What Should I Expect?
Screening Phase
During screening, you will review and sign a consent form, answer questions about your medical history, have a physical examination, a DXA scan, a test that checks how strong your bones are, and complete blood and other laboratory tests. You will also have a FibroScan, a painless test that measures liver stiffness, and a pregnancy test if needed.
The study team will also check whether you meet all of the study requirements. There are two screening visits that occur before Day 1 of the study.
Randomization Visit
If you qualify and choose to join the study, you will be assigned by chance to receive either efimosfermin alfa or a placebo (a treatment that looks like the study medicine but does not contain any active medicine).
You have a 75% chance of receiving efimosfermin alfa and a 25% chance of receiving placebo.
Neither you nor the study team will know which treatment you receive during the study, except if needed for safety reasons.
Treatment Phase
During the treatment period, you will receive one injection of the study treatment under the skin of your abdomen (belly) every 4 weeks for 48 weeks.
At study visits, the study team will monitor your health, ask about any side effects, collect blood and urine samples, perform FibroScan tests to check your liver, and ask you to complete questionnaires.
Follow Up Visit
After treatment ends, you will have follow-up visits at Weeks 52, 56, and 60 so the study team can continue to monitor your health and safety.