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Vutrisiran shows promise for Long-Term control of rare heart condition

NCT ID NCT06679946

Disease control Sponsor: Alnylam Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is for people with a rare heart condition called ATTR amyloidosis with cardiomyopathy, where abnormal protein builds up in the heart. It tests the long-term safety and effectiveness of a drug called vutrisiran, given as an injection every three months. About 700 adults who were already in earlier studies of vutrisiran or a similar drug (patisiran) will take part. The goal is to see if the drug remains safe and helps control the disease over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vutrisiran (a drug given as an injection every 3 months)
What this could lead to
If successful, this study could confirm that vutrisiran is a safe and effective long-term treatment for people with ATTR amyloidosis with cardiomyopathy, helping to manage the disease and improve quality of life.
What could go wrong
This is an extension study, not a new treatment test. It is open-label (everyone knows they get the drug), so results may be less reliable. Side effects are possible, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients who are participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003 Exclusion Criteria: * Has permanently discontinued study drug administration while participating in the parent studies, ALN-TTR02-011, ALN-TTR02-014, or ALN-TTRSC02-003 * Future or current participation in another investigational device or drug study, scheduled to occur during this study * Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

amyloidosis ATTRV122I amyloidosis cardiomyopathy familial amyloid neuropathy wild type ATTR amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transthyretin amyloidosis (ATTR) with cardiomyopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    87 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Trial Site

    Phoenix, Arizona, 85054, United States

  • Clinical Trial Site

    Beverly Hills, California, 90211, United States

  • Clinical Trial Site

    La Jolla, California, 92037, United States

  • Clinical Trial Site

    Stanford, California, 94305, United States

  • Clinical Trial Site

    Washington D.C., District of Columbia, 20010, United States

  • Clinical Trial Site

    Chicago, Illinois, 60637, United States

  • Clinical Trial Site

    Glenview, Illinois, 60026, United States

  • Clinical Trial Site

    Indianapolis, Indiana, 46202, United States

  • Clinical Trial Site

    Kansas City, Kansas, 66160, United States

  • Clinical Trial Site

    Baltimore, Maryland, 21287, United States

  • Clinical Trial Site

    Boston, Massachusetts, 02115, United States

  • Clinical Trial Site

    Boston, Massachusetts, 02118, United States

  • Clinical Trial Site

    Rochester, Minnesota, 55905, United States

  • Clinical Trial Site

    St Louis, Missouri, 63110, United States

  • Clinical Trial Site

    Omaha, Nebraska, 68198, United States

  • Clinical Trial Site

    New York, New York, 10029, United States

  • Clinical Trial Site

    New York, New York, 10032, United States

  • Clinical Trial Site

    Durham, North Carolina, 27710, United States

  • Clinical Trial Site

    Cleveland, Ohio, 44195, United States

  • Clinical Trial Site

    Columbus, Ohio, 43214, United States

  • Clinical Trial Site

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Trial Site

    Nashville, Tennessee, 37232, United States

  • Clinical Trial Site

    Dallas, Texas, 75246, United States

  • Clinical Trial Site

    Salt Lake City, Utah, 84132, United States

  • Clinical Trial Site

    Buenos Aires, C1093AAS, Argentina

  • Clinical Trial Site

    Buenos Aires, C1199ABB, Argentina

  • Clinical Trial Site

    Buenos Aires, C1428, Argentina

  • Clinical Trial Site

    Córdoba, X5000KEH, Argentina

  • Clinical Trial Site

    Rosario, S2000DEJ, Argentina

  • Clinical Trial Site

    Rosario, S2000DSR, Argentina

  • Clinical Trial Site

    Rosario, S2000PBJ, Argentina

  • Clinical Trial Site

    Vienna, 1090, Austria

  • Clinical Trial Site

    Vienna, 1210, Austria

  • Clinical Trial Site

    Aalst, 9300, Belgium

  • Clinical Trial Site

    Anderlecht, 1070, Belgium

  • Clinical Trial Site

    Dendermonde, 9200, Belgium

  • Clinical Trial Site

    Ghent, 9000, Belgium

  • Clinical Trial Site

    Hasselt, 3500, Belgium

  • Clinical Trial Site

    Leuven, 3000, Belgium

  • Clinical Trial Site

    Liège, 4000, Belgium

  • Clinical Trial Site

    Roeselare, 8800, Belgium

  • Clinical Trial Site

    Ribeirão Preto, 14026-900, Brazil

  • Clinical Trial Site

    Ribeirão Preto, 14051-140, Brazil

  • Clinical Trial Site

    Rio de Janeiro, 22280-020, Brazil

  • Clinical Trial Site

    São Paulo, 04012-180, Brazil

  • Clinical Trial Site

    São Paulo, 05403-000, Brazil

  • Clinical Trial Site

    Prague, 120 00, Czechia

  • Clinical Trial Site

    Prague, 128 21, Czechia

  • Clinical Trial Site

    Prague, 140 21, Czechia

  • Clinical Trial Site

    Aarhus N, 8200, Denmark

  • Clinical Trial Site

    København Ø, 2100, Denmark

  • Clinical Trial Site

    Odense C, 5000, Denmark

  • Clinical Trial Site

    Créteil, 94000, France

  • Clinical Trial Site

    Marseille, 13005, France

  • Clinical Trial Site

    Paris, 75018, France

  • Clinical Trial Site

    Rennes, 35000, France

  • Clinical Trial Site

    Toulouse, 31059, France

  • Clinical Trial Site

    Bologna, 40138, Italy

  • Clinical Trial Site

    Florence, 50134, Italy

  • Clinical Trial Site

    Pavia, 27100, Italy

  • Clinical Trial Site

    Groningen, 9713 GZ, Netherlands

  • Clinical Trial Site

    Maastricht, 6229 HX, Netherlands

  • Clinical Trial Site

    Utrecht, 3584 CX, Netherlands

  • Clinical Trial Site

    Oslo, 372, Norway

  • Clinical Trial Site

    Creixomil, 4835-044, Portugal

  • Clinical Trial Site

    Lisbon, 1649-035, Portugal

  • Clinical Trial Site

    Porto, 4099-001, Portugal

  • Clinical Trial Site

    Viseu, 3504-509, Portugal

  • Clinical Trial Site

    Seoul, 03080, South Korea

  • Clinical Trial Site

    Seoul, 03722, South Korea

  • Clinical Trial Site

    Seoul, 06351, South Korea

  • Clinical Trial Site

    Barcelona, 08035, Spain

  • Clinical Trial Site

    Bilbao, 48013, Spain

  • Clinical Trial Site

    L'Hospitalet de Llobregat, 8907, Spain

  • Clinical Trial Site

    Madrid, 28222, Spain

  • Clinical Trial Site

    Málaga, 29010, Spain

  • Clinical Trial Site

    Gothenburg, 413 45, Sweden

  • Clinical Trial Site

    Solna, 171 76, Sweden

  • Clinical Trial Site

    Umeå, 907 37, Sweden

  • Clinical Trial Site

    Taipei, 112, Taiwan

  • Clinical Trial Site

    Bellshill, ML4 3NJ, United Kingdom

  • Clinical Trial Site

    Birmingham, B15 2SQ, United Kingdom

  • Clinical Trial Site

    Cardiff, CF15 9SS, United Kingdom

  • Clinical Trial Site

    Hexham, NE46 1QJ, United Kingdom

  • Clinical Trial Site

    London, NW3 2QG, United Kingdom

  • Clinical Trial Site

    London, SE1 1YR, United Kingdom

  • Clinical Trial Site

    Manchester, M15 6SE, United Kingdom

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