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Recruiting Phase 3 Interventional

Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein

ClinicalTrials.gov ID: NCT05677971

Public ClinicalTrials.gov record NCT05677971. 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 6, 2026, 4:40 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 Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis

Brief summary

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

The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.

Study identification

NCT ID
NCT05677971
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Takeda
Industry
Enrollment
160 participants

Conditions and interventions

Interventions

Drug · Other

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
Mar 5, 2023
Primary completion
Jan 16, 2029
Completion
Dec 11, 2031
Last update posted
May 12, 2026

2023 – 2031

United States locations

U.S. sites
37
U.S. states
21
U.S. cities
31
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 Recruiting
St. Joseph's Hospital and Medical Center Phoenix Arizona 85013 Recruiting
Mayo Clinic Phoenix Arizona 85054-4502 Recruiting
University of Arizona Thomas D. Boyer Liver Institute Tucson Arizona 85724-5136 Withdrawn
Gastroenterology & Liver Institute Escondido California 92025 Withdrawn
University of California San Diego, Altman Clinical and Translational Institute La Jolla California 92093 Recruiting
UCLA Pulmonary and Critical Care Los Angeles California 90095-8344 Recruiting
Stanford University Palo Alto California 94303 Recruiting
University of California Benioff Children's Hospital San Francisco California 94143 Recruiting
Peak Gastroenterology Associates, PC Colorado Springs Colorado 80907 Recruiting
University of Florida Gainesville Florida 32611 Recruiting
Schiff Center for Liver Diseases/University of Miami Miami Florida 33136-1051 Recruiting
Children's Healthcare of Atlanta Atlanta Georgia 30329 Withdrawn
Indiana University School of Medicine - Indianapolis Indianapolis Indiana 46202 Recruiting
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 Recruiting
Ochsner Medical Center New Orleans Louisiana 70121-2429 Recruiting
University of Maryland Medical Center Baltimore Maryland 21201-1504 Recruiting
Brigham and Womens Hospital Boston Massachusetts 02115 Recruiting
Boston Medical Center Boston Massachusetts 02118-2908 Recruiting
University of Michigan Hospital Ann Arbor Michigan 48109 Recruiting
Henry Ford Medical Center - Columbus Novi Michigan 48377-3600 Recruiting
Mayo Clinic - PPDS Rochester Minnesota 55905-0001 Recruiting
Cardinal Glennon Children's Hospital St Louis Missouri 63104-1003 Recruiting
Washington University School of Medicine in St. Louis St Louis Missouri 63110 Recruiting
NYU Langone Health New York New York 10016 Recruiting
Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) - PIN New York New York 10032-1559 Withdrawn
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 Recruiting
Temple University Hospital Philadelphia Pennsylvania 19140-5103 Recruiting
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37232-0028 Recruiting
Texoma Liver Center Denison Texas 75020 Recruiting
Baylor College of Medicine Medical Center Houston Texas 77030-4202 Recruiting
The Texas Liver Institute San Antonio Texas 78215 Recruiting
Bon Secours St. Mary's Hospital Richmond Virginia 23226 Recruiting
VCU Medical Center North Hospital Richmond Virginia 23298-5028 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 52 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05677971, 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 May 12, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05677971 live on ClinicalTrials.gov.

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