Purpose of The Redwood Study

The purpose of The Redwood Study is to evaluate the safety and effectiveness of an investigational study drug, called TAK-999 (fazirsiran), in adults 18 to 75 years of age with Alpha-1 Liver Disease. The investigational study drug will be compared to a placebo; both groups will receive injections, but the placebo contains no active medication. This study may help researchers understand whether TAK-999 can reduce liver scarring caused by Alpha-1 Liver Disease.

Who May Qualify

If you or any of your family members have a confirmed or suspected diagnosis of Alpha-1 Liver Disease, you may be eligible for this study.

If you are interested, a participating research site can confirm a diagnosis of Alpha-1 Liver Disease, as well as other study criteria, to determine your eligibility.

Study Participation

Participation in The Redwood Study will last approximately four and a half years and consists of three periods:

Screening period

Lasts up to 10 weeks and consists of one or more study visits. During this period, the study team will perform tests and procedures to determine your eligibility for the study. The study team can confirm a diagnosis of Alpha-1 Liver Disease during this period.

Treatment period

Lasts up to four years and consists of up to 28 visits to the study site. Participants will be randomized to receive the investigational study drug or the placebo. Both the investigational study drug and the placebo are administered as injections.

Follow-up period

Participants will be followed for up to six months after their last dose of their study treatment for continued monitoring of their health.

About the Investigational Study Drug

There is currently no approved treatment available for Alpha-1 Liver Disease. The investigational study drug, TAK-999, aims to reduce production of the abnormal Z-AAT protein and its buildup in the liver. The reduction in levels of the protein may result in a decrease in liver scarring.

Researchers are investigating the safety and effectiveness of TAK-999 in adults with Alpha-1 Liver Disease. The investigational study drug will be evaluated alongside placebo to help researchers determine if TAK-999 may reduce liver scarring caused by Alpha-1 Liver Disease. The use of a placebo (contains no active medication) in this study will help the researchers by providing a group that does not receive medication to compare with a group that does.

There are two treatment groups in this study, with one group receiving the investigational study drug and the other receiving the placebo. Each participant will be randomly assigned to one of the groups and will receive their assigned study treatment as an injection. During the treatment period, neither the participant nor the study doctor will know which group the participant is in, but in the case of an emergency, the study doctor can quickly find out.

See if you may qualify