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)

ClinicalTrials.gov ID: NCT06165341

Public ClinicalTrials.gov record NCT06165341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F1 Fibrosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06165341
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Takeda; Industry
Enrollment: 50 participants

Conditions and interventions

Conditions

Alpha1-Antitrypsin Deficiency

Interventions

Fazirsiran Injection Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 29, 2024
Primary completion: Aug 25, 2028
Completion: Aug 25, 2028
Last update posted: Mar 4, 2026

2024 – 2028

United States locations

U.S. sites: 20
U.S. states: 14
U.S. cities: 18

Facility	City	State	ZIP	Site status
St Joseph's Hospital and Medical Center	Phoenix	Arizona	85013-4224	Recruiting
Mayo Clinic - PPDS	Phoenix	Arizona	85054-4502	Recruiting
University of Arizona Thomas D. Boyer Liver Institute	Tucson	Arizona	85724-0001	Recruiting
University of California San Diego	La Jolla	California	92037-1337	Recruiting
UCLA Pulmonary and Critical Care	Los Angeles	California	90095-3075	Recruiting
University of California Benioff Children's Hospital	San Francisco	California	94143-2203	Recruiting
Peak Gastroenterology Associates	Colorado Springs	Colorado	80907	Recruiting
Schiff Center for Liver Diseases/University of Miami	Miami	Florida	33136	Recruiting
Indiana University School of Medicine-Indianapolis	Indianapolis	Indiana	46202-2266	Recruiting
University Of Iowa Hospitals And Clinics	Iowa City	Iowa	52242-1009	Recruiting
Boston Medical Center	Boston	Massachusetts	02118-2335	Recruiting
University of Michigan Hospital - 1500 E Medical Center Dr	Ann Arbor	Michigan	48109	Recruiting
Henry Ford Health System	Novi	Michigan	48377-3600	Recruiting
Mayo Clinic PPDS	Rochester	Minnesota	55905	Recruiting
NYU Langone Medical Center	New York	New York	10016-6402	Recruiting
Columbia University Irving Medical Center	New York	New York	10032-3722	Recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	44106-1716	Recruiting
Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania	17033-2360	Recruiting
Texas Liver Institute American Research Corporation	San Antonio	Texas	78215	Recruiting
Bon Secours St. Mary's Hospital	Newport	Virginia	23602-4414	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06165341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 4, 2026 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06165341 live on ClinicalTrials.gov.

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