Clinical Trial
Study Details
Participants will receive placebo via IV infusion.
Outcomes
Study Overview
The primary objective of this study is to assess the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the composite endpoint of all-cause mortality (ACM) and total cardiovascular (CV) clinical events.
Contacts and Locations
Research Site
Irvine, CA 92614
United States
Research Site
La Jolla, CA 92037
United States
Research Site
Palo Alto, CA 94304
United States
Research Site
San Francisco, CA 94143
United States
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Aurora, CO 80045
United States
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Washington, DC 20010
United States
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Jacksonville, FL 32224
United States
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Weston, FL 33331
United States
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Atlanta, GA 30309
United States
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Atlanta, GA 30322
United States
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Chicago, IL 60611
United States
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Chicago, IL 60637
United States
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Indianapolis, IN 46202
United States
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Kansas City, KS 66160
United States
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Boston, MA 02115
United States
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Boston, MA 02118
United States
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Minneapolis, MN 55417
United States
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Minneapolis, MN 55421
United States
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Rochester, MN 55905
United States
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Kansas City, MO 64111
United States
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Saint Louis, MO 63110
United States
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New York, NY 10016
United States
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New York, NY 10032
United States
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Stony Brook, NY 11794
United States
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Chapel Hill, NC 27599
United States
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Durham, NC 27705
United States
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Cleveland, OH 44195
United States
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Columbus, OH 43210
United States
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Portland, OR 97239
United States
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Danville, PA 17822
United States
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Philadelphia, PA 19104
United States
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Providence, RI 02908
United States
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Charleston, SC 29425
United States
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Greenville, SC 29605
United States
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Nashville, TN 37232
United States
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Fort Worth, TX 76104
United States
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Houston, TX 77030
United States
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Salt Lake City, UT 84132
United States
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Falls Church, VA 22042
United States
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Richmond, VA 23298
United States
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Seattle, WA 98195
United States
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Madison, WI 53705
United States
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1425 Buenos Aires
Argentina
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C1110 AAF Buenos Aires
Argentina
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C1006ACC Caba
Argentina
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C1428DCO Caba
Argentina
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C1181ACH Ciudad Autonoma Buenos Aires
Argentina
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X5016 Cordoba
Argentina
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B1629AHJ Pilar
Argentina
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Box Hill 3128
Australia
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Brisbane 4102
Australia
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Darlinghurst 2010
Australia
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Joondalup 6027
Australia
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Melbourne 3004
Australia
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Westmead 2145
Australia
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8036 Graz
Austria
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6020 Innsbruck
Austria
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4600 Wels
Austria
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1090 Wien
Austria
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1160 Wien
Austria
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8000 Bruges
Belgium
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1070 Brussels
Belgium
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3600 Genk
Belgium
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Campinas
13083
Brazil
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Fortaleza
60430-375
Brazil
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Porto Alegre
90560-030
Brazil
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Ribeirão Preto
14026-020
Brazil
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Ribeirão Preto
14051-140
Brazil
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Rio de Janeiro
20551-030
Brazil
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Rio de Janeiro
22270-005
Brazil
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Sao Paulo
05403-000
Brazil
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Sao Paulo
05652-900
Brazil
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São Paulo
01323-001
Brazil
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São Paulo
01409-02
Brazil
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São Paulo
04012-909
Brazil
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Calgary AB T2N 1N4
Canada
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Vancouver BC V5Z 1M9
Canada
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Winnipeg MB R2H 2A6
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London ON N6C 2R5
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Toronto ON M5G 2C4
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Chicoutimi QC G7H 5H6
Canada
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Montréal QC H1T 1C8
Canada
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Montréal QC H2X 0A9
Canada
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Rimouski QC G5L 5T1
Canada
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Beijing
100029
China
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Beijing
100034
China
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Beijing
100037
China
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Beijing
100191
China
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Beijing
100730
China
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Changsha
430033
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Chengdu
610000
China
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Chengdu
610072
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Chongqing
400042
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Dalian
116011
China
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Fuzhou
350005
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Guangzhou
510080
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Guiyang
550044
China
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Hangzhou
310003
China
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Hangzhou
310009
China
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Hangzhou
310014
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Harbin
150001
China
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Hefei
230001
China
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Jinan
250021
China
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Nanjing
210029
China
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Shanghai
200032
China
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Tianjin
300222
China
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Wuhan
430022
China
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Wuhan
430030
China
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Xi'an
710061
China
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656 91 Brno
Czechia
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140 00 Praha 4
Czechia
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128 08 Praha
Czechia
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8200 Aarhus
Denmark
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DK-2100 Copenhagen
Denmark
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5000 Odense C
Denmark
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69677 Bron
France
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37170 Chambray Les Tours
France
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94010 Créteil Cédex
France
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13005 Marseille
France
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34295 Montpellier
France
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75651 Paris Cedex 13
France
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75018 Paris
France
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33604 Pessac
France
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86021 Poitiers
France
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35033 Rennes Cedex 9
France
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44093 Saint-Herblain
France
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31059 Toulouse
France
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53127 Bonn
Germany
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50937 Cologne
Germany
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45147 Essen
Germany
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35392 Gießen
Germany
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17489 Greifwald
Germany
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37075 Göttingen
Germany
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22767 Hamburg
Germany
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30625 Hannover
Germany
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69120 Heidelberg
Germany
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66421 Homburg
Germany
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24105 Kiel
Germany
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04103 Leipzig
Germany
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81377 München
Germany
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48149 Münster
Germany
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97078 Würzburg
Germany
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97078 Würzburg
Germany
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11528 Athens
Greece
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11528 Athens
Greece
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Dublin
7
Ireland
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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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Haifa 34362
Israel
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Jerusalem 91120
Israel
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Jerusalem 9372212
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Petah Tikva 4941492
Israel
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Rehovot 76100
Israel
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40138 Bologna
Italy
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44124 Ferrara
Italy
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50134 Florence
Italy
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47121 Forli
Italy
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98124 Messina
Italy
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20122 Milano
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80131 Napoli
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35128 Padova
Italy
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27100 Pavia
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56124 Pisa
Italy
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00189 Roma
Italy
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10154 Torino
Italy
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34128 Trieste
Italy
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Bunkyo-ku
113-8431
Japan
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Kumamoto-shi
860-8556
Japan
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Kurume-shi
830-0011
Japan
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Kyoto-shi
602-8566
Japan
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Matsumoto-shi
390-8621
Japan
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Sapporo-shi
060-8543
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Shinjuku-ku
160-8582
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Suita-shi
564-8565
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9713 GZ Groningen
Netherlands
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6229 Maastricht
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3015 GD Rotterdam
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3584 Utrecht
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Auckland 2025
New Zealand
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N-1478 Lørenskog
Norway
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0372 Oslo
Norway
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7030 Trondheim
Norway
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80-952 Gdansk
Poland
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31-202 Krakow
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61-848 Poznań
Poland
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02-097 Warszawa
Poland
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04-628 Warszawa
Poland
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8035 Barcelona
Spain
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30120 El Palmar
Spain
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23007 Jaen
Spain
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08907 L'Hospitalet de Llobregat
Spain
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15006 La Coruna
Spain
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28027 Madrid
Spain
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28222 Majadahonda
Spain
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29010 Malaga
Spain
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07198 Palma de Mallorca
Spain
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31008 Pamplona
Spain
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37007 Salamanca
Spain
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15706 Santiago De Compostela-Coruña
Spain
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46010 Valencia
Spain
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41345 Göteborg
Sweden
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221 85 Lund
Sweden
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171 64 Stockholm
Sweden
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4031 Basel
Switzerland
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3010 Bern
Switzerland
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6000 Luzern
Switzerland
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9007 St.Gallen
Switzerland
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8006 Zürich
Switzerland
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New Taipei City, 220
Taiwan
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Taichung, 404
Taiwan
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Taichung, 40705
Taiwan
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Taipei, 10002
Taiwan
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Taipei, 112201
Taiwan
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06230 Ankara/
Türkiye
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03400 Dinar/
Türkiye
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26480 Eskisehir/
Türkiye
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34180 Istanbul/
Türkiye
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34303 Istanbul/
Türkiye
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35340 Izmir/
Türkiye
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33079 Mersin/
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Birmingham
B15 2SQ
United Kingdom
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Cardiff
CF15 9SS
United Kingdom
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Glasgow
G20 0SP
United Kingdom
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Hexham
NE46 1QJ
United Kingdom
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London
NW3 2QG
United Kingdom
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London
SE1 1YR
United Kingdom
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London
SW17 0QT
United Kingdom
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Manchester
M15 6SE
United Kingdom
Participation Criteria
Inclusion Criteria:
* Centrally confirmed diagnosis of ATTR-CM with either wild-type or variant TTR genotype
* End-diastolic interventricular septal wall thickness ≥ 11 mm for women or ≥ 12 mm for men on echocardiography measured at Screening
* NT-proBNP \> 2000 pg/mL at Screening
* Treatment with a loop diuretic for at least 30 days prior to Screening
* History of heart failure NYHA Class II-IV at Screening
* Life expectancy of ≥ 6 months as per the Investigator's judgment
* Males and females of childbearing ability must use contraception
Exclusion Criteria:
* Known leptomeningeal amyloidosis
* Known light chain (AL) or secondary amyloidosis (AA), or any other form of systemic amyloidosis
* Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening
* Uncontrolled clinically significant cardiac arrhythmia, per Investigator's assessment
* LVEF \< 30% on echocardiography
* Renal failure requiring dialysis or an eGFR \< 20 mL/min/1.73 m2 at Screening
* Polyneuropathy with PND score IV