Can a new infusion slow a heart disease caused by protein clumps?

NCT ID NCT07789483

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This study tests the long-term safety and effectiveness of an experimental drug called ALXN2220 in adults with transthyretin amyloid cardiomyopathy (ATTR-CM), a condition where abnormal proteins build up in the heart and impair its function. Participants who completed an earlier trial of ALXN2220 will continue receiving the drug as an IV infusion alongside their standard care. Researchers will track side effects and measure how the drug affects heart-related events and survival 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: ALXN2220 (also known as Cliramitug or NI006), given as an IV infusion
What this could lead to: If it works, ALXN2220 could offer a long-term treatment option to slow the progression of transthyretin amyloid cardiomyopathy and reduce heart-related complications.
What could go wrong: This is an extension study, so it builds on earlier results. The drug may still cause side effects, and its long-term benefits are not yet proven.

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 1,180 people

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

Expected to start

Nov 2027

An estimate. Start dates often move.

Expected to finish

Jul 2030

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 * Type of Participant: Participants who have completed the Blinded Treatment Period (including the PC visit) of Study 301. * Sex and Contraceptive/Barrier Requirements: Male and/or female (according to their reproductive organs and functions assigned by chromosomal complement). * Informed Consent: Participant, or legally authorized representative where relevant and allowed by law, is willing and able to comply with all study requirements and to provide signed informed consent. * Exclusion Criteria * Participants who permanently discontinued study intervention in Study 301 * Participants who withdrew full consent during Study 301. * Medical Conditions: Suspected or known intolerance/allergy to proteins or any components of ALXN2220. Has had a heart transplant or permanent CMAD implantation. Has any new or worsening of existing medical or psychological condition or risk factor that in the opinion of the Investigator or Sponsor might jeopardize participant's safety or compliance with the protocol, or pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study. * Prior/Concurrent/Future Clinical Study Experience: Current or future participation in another investigational clinical study or intake of investigational drug within 30 calendar days or 5 half-lives of the study intervention, whichever is longer, before signing the ICF, except for study intervention used in Study 301.

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Conditions

The condition(s) this trial relates to.

wild type ATTR amyloidosis

As listed by the trial registrant

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

Transthyretin amyloid cardiomyopathy (attr-CM)

How to take part

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

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

195 sites in 27 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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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

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Research Site

Irvine, California, 92614, United States
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La Jolla, California, 92037, United States
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Palo Alto, California, 94304, United States
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San Francisco, California, 94143, United States
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Aurora, Colorado, 80045, United States
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Washington D.C., District of Columbia, 20010, United States
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Jacksonville, Florida, 32224, United States
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Weston, Florida, 33331, United States
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Atlanta, Georgia, 30309, United States
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Atlanta, Georgia, 30322, United States
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Indianapolis, Indiana, 46202, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02118, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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New York, New York, 10016, United States
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New York, New York, 10032, United States
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Stony Brook, New York, 11794, United States
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Chapel Hill, North Carolina, 27599, United States
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Durham, North Carolina, 27705, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Portland, Oregon, 97239, United States
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Danville, Pennsylvania, 17822, United States
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Philadelphia, Pennsylvania, 19104, United States
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Charleston, South Carolina, 29425, United States
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Greenville, South Carolina, 29605, United States
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Memphis, Tennessee, 38120, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84132, United States
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Falls Church, Virginia, 22042, United States
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Richmond, Virginia, 23298, United States
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Seattle, Washington, 98195, United States
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Madison, Wisconsin, 53705, United States
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Buenos Aires, Buenos Aires, 1425, Argentina
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CABA, Buenos Aires, C1025ABI, Argentina
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Ciudad de Buenos Aires, Buenos Aires F.D., C1181ACH, Argentina
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Córdoba, Córdoba Province, X5016KEH, Argentina
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Ciudad de Buenos Aires, C1428, Argentina
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Darlinghurst, New South Wales, 2010, Australia
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Westmead, New South Wales, 2145, Australia
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Brisbane, Queensland, 4102, Australia
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Bedford Park, South Australia, 5042, Australia
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Box Hill, Victoria, 3128, Australia
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Melbourne, Victoria, 3004, Australia
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Joondalup, Western Australia, 6027, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Vienna, 1160, Austria
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Wels, 4600, Austria
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Bruges, West-Vlaanderen, 8000, Belgium
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Genk, 3600, Belgium
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Fortaleza, Ceará, 60430-375, Brazil
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Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
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Rio de Janeiro, Rio de Janeiro, 22270-005, Brazil
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Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
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Campinas, São Paulo, 13083, Brazil
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Ribeirão Preto, São Paulo, 14026-020, Brazil
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Ribeirão Preto, São Paulo, 14051-140, Brazil
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São Paulo, São Paulo, 04012-909, Brazil
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São Paulo, São Paulo, 05403-000, Brazil
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São Paulo, São Paulo, 05652-900, Brazil
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Calgary, Alberta, T2N 1N4, Canada
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Winnipeg, Manitoba, R2H 2A6, Canada
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London, Ontario, N6A 5A5, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Montr Al, Quebec, H1T 1C8, Canada
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Montr Al, Quebec, H2X 1R9, Canada
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Rimouski, Quebec, G5L 5T1, Canada
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Beijing, Beijing Municipality, 100037, China
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Beijing, Beijing Municipality, 100191, China
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Chongqing, Chongqing Municipality, 400042, China
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Guangzhou, Guangdong, 510080, China
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Guiyang, Guizhou, 550044, China
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Harbin, Heilongjiang, 150080, China
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Wuhan, Hubei, 430030, China
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Changsha, Hunan, 430033, China
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Nanjing, Jiangsu, 210029, China
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Xi'an, Shaanxi, 710061, China
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Jinan, Shangdong, 250021, China
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Shanghai, Shanghai Municipality, 201114, China
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Hangzhou, Zhejiang, 310003, China
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Hangzhou, Zhejiang, 310009, China
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Beijing, 100730, China
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Tianjin, 300457, China
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Praha, Central Bohemia, 140 00, Czechia
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Prague, 128 08, Czechia
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Aarhus, 8200, Denmark
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Odense C, 5000, Denmark
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Bron, 69677, France
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Chambray-lès-Tours, 37170, France
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Créteil, 94010, France
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Marseille, 13005, France
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Montpellier, 34295, France
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Paris, 75018, France
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Paris, 75651, France
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Pessac, 33604, France
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Poitiers, 86021, France
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Rennes, 35033, France
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Saint-Herblain, 44093, France
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Toulouse, 31059, France
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Berlin, Deutschalnd, 10117, Germany
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Hanover, Lower Saxony, 30625, Germany
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Münster, Munster, 48149, Germany
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Cologne, North Rhine-Westphalia, 50937, Germany
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Homburg, Saarland, 66421, Germany
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Leipzig, Saxony, 04103, Germany
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Kiel, Schleswig-Holstein, 24105, Germany
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Essen, 45147, Germany
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Gie En, 35392, Germany
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Hamburg, 22767, Germany
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Heidelberg, 69120, Germany
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M Nchen, 81377, Germany
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W Rzburg, 97078, Germany
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Athens, Attica, 11528, Greece
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Dublin, 8, Ireland
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Beer Yaakov, 70300, Israel
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Rehovot, 76100, Israel
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Bologna, Bologna, 40138, Italy
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Forlì, Emilia-Romagna, 47121, Italy
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Florence, Florence, 50134, Italy
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Rome, Lazio, 00189, Italy
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Messina, Messina, 98124, Italy
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Naples, Napoli, 80131, Italy
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Padova, Padova, 35128, Italy
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Pisa, PI, 56124, Italy
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Torino, TO, 10154, Italy
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Trieste, TS, 34128, Italy
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Ferrara, 44124, Italy
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Milan, 20122, Italy
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Pavia, 27100, Italy
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Kurume-shi, Fukuoka, 830-0011, Japan
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Sapporo, Hokkaido, 060-8543, Japan
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Kumamoto, Kumamoto, 860-8556, Japan
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Kyoto, Kyoto, 602-8566, Japan
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Matsumoto-shi, Nagano, 390-8621, Japan
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Suita-shi, Osaka, 564-8565, Japan
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Bunkyo-ku, Tokyo, 113-8431, Japan
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Shinjuku-ku, Tokyo, 160-8582, Japan
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Groningen, 9713 GZ, Netherlands
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Maastricht, 6229 HX, Netherlands
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Rotterdam, 3015 GD, Netherlands
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Utrecht, 3584 CX, Netherlands
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Trondheim, Trøndelag, 7030, Norway
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Lorenskog, N-1478, Norway
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Oslo, 0372, Norway
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Warsaw, Masovian Voivodeship, 02-097, Poland
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Gdansk, Pomeranian Voivodeship, 80-952, Poland
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Poznan, 61-848, Poland
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Seoul, Seoul, 03080, South Korea
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Seoul, Seoul, 03722, South Korea
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Seoul, Seoul, 06351, South Korea
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Seoul, Seoul, 06591, South Korea
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Seoul, Seoul, 5505, South Korea
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Busan, 49241, South Korea
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Jaén, Andalusia, 23007, Spain
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Málaga, Andalusia, 29010, Spain
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Palma de Mallorca, Balearic Islands, 07198, Spain
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Salamanca, Castille and León, 37007, Spain
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Barcelona, Catalonia, 8035, Spain
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L'Hospitalet de Llobregat, Catalonia, 08907, Spain
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Valencia, Comunidad Valencia, 46010, Spain
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A Coruña, Galicia, 15009, Spain
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Santiago de Compostela-Coru A, Galicia, 15706, Spain
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Madrid, Madrid, 28027, Spain
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Majadahonda, Madrid, 28222, Spain
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El Palmar, Murcia, 30120, Spain
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Pamplona, Navarre, 31008, Spain
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Skellefte, Skelleftea, 93186, Sweden
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Lund, Skåne County, 22242, Sweden
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Gothenburg, 413 45, Sweden
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Stockholm, 171 64, Sweden
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Basel, 4031, Switzerland
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Bern, 3010, Switzerland
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Lucerne, 6000, Switzerland
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Sankt Gallen, 9007, Switzerland
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Zurich, 8091, Switzerland
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Taichung, Taichung, 404, Taiwan
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Taichung, Taichung, 40705, Taiwan
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Taipei, Taipei, 10002, Taiwan
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Taipei, Taiwan, 11217, Taiwan
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Mersin, Mersin, 33079, Turkey (Türkiye)
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Dinar, 03400, Turkey (Türkiye)
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Eskişehir, 26480, Turkey (Türkiye)
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Istanbul, 34303, Turkey (Türkiye)
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Birmingham, Edgbaston, B16 8QQ, United Kingdom
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London, GREATER LONDON, NW3 2QG, United Kingdom
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London, London, SE1 1YR, United Kingdom
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Glasgow, Scotland, G20 0SP, United Kingdom
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Cardiff, CF15 9SS, United Kingdom
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Manchester, M15 6SE, United Kingdom

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