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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)
NCT06165341 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fazirsiran Injection
Study Locations (20)
Arizona
- St Joseph's Hospital and Medical Center — Phoenix
- Mayo Clinic - PPDS — Phoenix
- University of Arizona Thomas D. Boyer Liver Institute — Tucson
California
- University of California San Diego — La Jolla
- UCLA Pulmonary and Critical Care — Los Angeles
- University of California Benioff Children's Hospital — San Francisco
Michigan
- University of Michigan Hospital - 1500 E Medical Center Dr — Ann Arbor
- Henry Ford Health System — Novi
New York
- NYU Langone Medical Center — New York
- Columbia University Irving Medical Center — New York
Colorado
- Peak Gastroenterology Associates — Colorado Springs
Florida
- Schiff Center for Liver Diseases/University of Miami — Miami
Indiana
- Indiana University School of Medicine-Indianapolis — Indianapolis
Iowa
- University Of Iowa Hospitals And Clinics — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2028-08-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06165341
The ClinicalTrials.gov registry entry for NCT06165341 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Alpha1-Antitrypsin Deficiency appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06165341 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Arizona, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06165341 about?
NCT06165341 is a clinical study titled "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)". 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 ce...
What is the current status of trial NCT06165341?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2024-03-01. Estimated completion is 2028-08-26.
What conditions does trial NCT06165341 study?
This clinical trial studies the following conditions: Alpha1-Antitrypsin Deficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06165341?
The interventions under investigation include: Placebo (DRUG), Fazirsiran Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06165341?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06165341 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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