Explore a Clinical Trial for Your Patients Living with Alpha-1 Liver Disease

The purpose of The Redwood Study is to understand how safe and effective an investigational study drug, fazirsiran, is compared to a placebo in the treatment of adults with Alpha-1 Liver Disease.

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About The Redwood Study

The Redwood Study is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the investigational study drug, fazirsiran, in participants with Alpha-1 Liver Disease. Participants will be randomized such that each participant has an equal chance of being assigned to either the investigational study drug or a placebo.

Participation will last approximately 4.5 years, including:

  • Screening: Up to 10 weeks

  • Treatment: Up to 196 weeks

  • Safety follow-up: 6 months

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About the Investigational Study Therapy

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

Study Purpose

The purpose of The Redwood Study is to evaluate the safety and effectiveness of an investigational study drug, fazirsiran, compared to a placebo in the treatment of adults with Alpha-1 Liver Disease.

Primary objective:

To evaluate the efficacy of fazirsiran compared with placebo at improving measures of histologic fibrosis in Alpha-1 Liver Disease.

Secondary objectives:

  • To evaluate the pharmacodynamic (PD) effect of fazirsiran via measurement of intrahepatic Z-alpha-1 antitrypsin (Z-AAT) protein (total).
  • To evaluate the impact of fazirsiran versus placebo on modulating disease progression as defined by progression to cirrhosis or decompensating liver-related clinical events.
  • To evaluate the safety and tolerability of fazirsiran compared with placebo with an emphasis on monitoring lung function, lung injury, and associated symptoms.
  • To evaluate the PD effect of fazirsiran via measurement of serum Z-AAT.
  • To evaluate the efficacy of fazirsiran compared with placebo at reducing histologic evidence of portal inflammation and Z-AAT polymer burden in the liver.
  • To use non-invasive measures of liver fibrosis (including biomarkers) to evaluate the efficacy of fazirsiran compared with placebo.
  • To evaluate the pharmacokinetics (PK) of fazirsiran.

Eligibility Criteria

Key Inclusion Criteria

Eligible participants must:

  • Be 18 to 75 years of age, inclusive.
  • Not have smoked any substance for the past 6 months.
  • Have a confirmed diagnosis of the PiZZ genotype Alpha-1 Antitrypsin Deficiency. PiZZ diagnosis from source verifiable medical records is permitted. NOTE: Participants may not yet have a diagnosis, but they can undergo PiZZ confirmatory testing (genotyping for PiS and protease inhibitor Z alleles) at screening.
  • Not have hepatocellular carcinoma (HCC).
  • Not have a history of liver-decompensating events.

Additional eligibility criteria may apply.

Refer a Patient

If you have a patient who you think may qualify, please refer them to take the prescreening questionnaire to determine their eligibility.

Find and Contact a Site Near You

Enter your zip code to find the participating research site(s) nearest you. You can also view the full list of participating research sites to determine which site you’re interested in referring a patient to.

Active site locations

Future site locations

Study Resources

Explore these resources to learn more about The Redwood Study. These materials can help your patients understand the study and decide whether participation may be right for them.

Study Brochure

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Study Fact Sheet

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Study Video