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Study identifier: NCT06165341 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis)

Condition: Alpha1-Antitrypsin Deficiency  ·  Sponsor: Takeda

PhasePhase 3
Planned participants50
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver disease as Z-AAT builds up in liver cells, which leads to liver problems such as liver scarring (fibrosis), continuing liver damage (cirrhosis), and eventually end stage liver disease. Fazirsiran is a medicine that reduces the creation of the Z-AAT protein and thus the build-up of this abnormal protein in the liver. People with this type of liver disease who already have mild liver scarring will take part in the study. They will be treated with fazirsiran or a placebo for about 2 years. This study will check the long-term safety of fazirsiran, whether participants tolerate the treatment and if there are any effects on liver scarring. A liver biopsy, a way of collecting a small tissue sample from the liver, will be taken twice during the study.

This description comes directly from the study's public registry record.

Talk to the study team

Takeda Contact  ·  +1-877-825-3327  ·  medinfoUS@takeda.com

Always discuss trial participation with your own doctor first.

Locations (41)

St Joseph's Hospital and Medical CenterPhoenix, Arizona, United StatesRecruiting
Mayo Clinic - PPDSPhoenix, Arizona, United StatesRecruiting
University of Arizona Thomas D. Boyer Liver InstituteTucson, Arizona, United StatesRecruiting
University of California San DiegoLa Jolla, California, United StatesRecruiting
UCLA Pulmonary and Critical CareLos Angeles, California, United StatesRecruiting
University of California Benioff Children's HospitalSan Francisco, California, United StatesRecruiting
Peak Gastroenterology AssociatesColorado Springs, Colorado, United StatesRecruiting
Schiff Center for Liver Diseases/University of MiamiMiami, Florida, United StatesRecruiting
Indiana University School of Medicine-IndianapolisIndianapolis, Indiana, United StatesRecruiting
University Of Iowa Hospitals And ClinicsIowa City, Iowa, United StatesRecruiting
Boston Medical CenterBoston, Massachusetts, United StatesRecruiting
University of Michigan Hospital - 1500 E Medical Center DrAnn Arbor, Michigan, United StatesRecruiting

+ 29 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06165341