AzTrials
AzTrials

Transthyretin Amyloidosis With CardiomyopathyPhase 3NCT07052903

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

A Phase 3 study testing Nucresiran and Sterile Normal Saline (0.9% NaCl) in people with Transthyretin Amyloidosis With Cardiomyopathy, run by Alnylam Pharmaceuticals at 266 sites in 36 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to: Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death Evaluate the efficacy of nucresiran compared to placebo on… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Nucresiran and Sterile Normal Saline (0.9% NaCl)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,750 participants
Where
266 sitesin 36 countries
Study dates
2 Jul 2025to 30 Nov 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis.
  • Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic.
  • Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) >300 ng/L and <8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP >600 ng/L and <8500 ng/L.
  • Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator.

Who cannot join

  • Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3.
  • Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV.
  • Has an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m^2 at screening.
  • Has received prior or currently receiving TTR-lowering therapy

Trial locations and contacts

266 sites in 36 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trial Information Line contact

1-877-ALNYLAM

clinicaltrials@alnylam.com

Clinical Trial Information Line contact

1-877-256-9526

clinicaltrials@alnylam.com

266 sites in 36 countries

United States45 sites, 45 recruiting

  • Clinical Trial Site

    Atlanta, Georgia, 30309

    Recruiting

  • Clinical Trial Site

    Aurora, Colorado, 80045

    Recruiting

  • Clinical Trial Site

    Austin, Texas, 78705

    Recruiting

  • Clinical Trial Site

    Baltimore, Maryland, 21287

    Recruiting

  • Clinical Trial Site

    Boston, Massachusetts, 02115

    Recruiting

  • Clinical Trial Site

    Boston, Massachusetts, 02118

    Recruiting

  • Clinical Trial Site

    Brandon, Florida, 33511

    Recruiting

  • Clinical Trial Site

    Charleston, South Carolina, 29425

    Recruiting

  • Clinical Trial Site

    Charlotte, North Carolina, 28204

    Recruiting

  • Clinical Trial Site

    Charlottesville, Virginia, 22903

    Recruiting

  • Clinical Trial Site

    Chicago, Illinois, 60612

    Recruiting

  • Clinical Trial Site

    Cleveland, Ohio, 44195

    Recruiting

  • Clinical Trial Site

    Columbus, Ohio, 43210

    Recruiting

  • Clinical Trial Site

    Dallas, Texas, 75246

    Recruiting

  • Clinical Trial Site

    Detroit, Michigan, 48202

    Recruiting

  • Clinical Trial Site

    Evanston, Illinois, 60201

    Recruiting

  • Clinical Trial Site

    Falls Church, Virginia, 22042

    Recruiting

  • Clinical Trial Site

    Gainesville, Georgia, 30501

    Recruiting

  • Clinical Trial Site

    Houston, Texas, 77030

    Recruiting

  • Clinical Trial Site

    Indianapolis, Indiana, 46202

    Recruiting

  • Clinical Trial Site

    Indianapolis, Indiana, 46260

    Recruiting

  • Clinical Trial Site

    Kansas City, Kansas, 66160

    Recruiting

  • Clinical Trial Site

    La Jolla, California, 92037

    Recruiting

  • Clinical Trial Site

    Laguna Hills, California, 92653

    Recruiting

  • Clinical Trial Site

    Lancaster, Pennsylvania, 17602

    Recruiting

  • Clinical Trial Site

    Manhasset, New York, 11030

    Recruiting

  • Clinical Trial Site

    Miami, Florida, 33125

    Recruiting

  • Clinical Trial Site

    New York, New York, 10029

    Recruiting

  • Clinical Trial Site

    New York, New York, 10032

    Recruiting

  • Clinical Trial Site

    New York, New York, 10065

    Recruiting

  • Clinical Trial Site

    Norfolk, Virginia, 23507

    Recruiting

  • Clinical Trial Site

    Norwich, Connecticut, 06360

    Recruiting

  • Clinical Trial Site

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Clinical Trial Site

    Plano, Texas, 75024

    Recruiting

  • Clinical Trial Site

    Portland, Oregon, 97239

    Recruiting

  • Clinical Trial Site

    Richmond, Virginia, 23298

    Recruiting

  • Clinical Trial Site

    Rochester, Minnesota, 55905

    Recruiting

  • Clinical Trial Site

    Salt Lake City, Utah, 84132

    Recruiting

  • Clinical Trial Site

    Seattle, Washington, 98195

    Recruiting

  • Clinical Trial Site

    Spokane, Washington, 99204

    Recruiting

  • Clinical Trial Site

    St Louis, Missouri, 63110

    Recruiting

  • Clinical Trial Site

    Stanford, California, 94305

    Recruiting

  • Clinical Trial Site

    The Bronx, New York, 10467

    Recruiting

  • Clinical Trial Site

    Tucker, Georgia, 30084

    Recruiting

  • Clinical Trial Site

    Washington D.C., District of Columbia, 20010

    Recruiting

Other trials in United States

China21 sites, 21 recruiting

  • Clinical Trial Site

    Binhai, 300456

    Recruiting

  • Clinical Trial Site

    Changsha, 410011

    Recruiting

  • Clinical Trial Site

    Changsha, 410013

    Recruiting

  • Clinical Trial Site

    Chengdu, 610041

    Recruiting

  • Clinical Trial Site

    Dongcheng, 100006

    Recruiting

  • Clinical Trial Site

    Fuzhou, 350004

    Recruiting

  • Clinical Trial Site

    Guangzhou, 510080

    Recruiting

  • Clinical Trial Site

    Haidian, 100191

    Recruiting

  • Clinical Trial Site

    Hangzhou, 310009

    Recruiting

  • Clinical Trial Site

    Hangzhou, 310014

    Recruiting

  • Clinical Trial Site

    Hefei, 230061

    Recruiting

  • Clinical Trial Site

    Hexi District, 300211

    Recruiting

  • Clinical Trial Site

    Jinan, 271000

    Recruiting

  • Clinical Trial Site

    Nanchang, 330030

    Recruiting

  • Clinical Trial Site

    Nangang, 150001

    Not yet recruiting

  • Clinical Trial Site

    Nanjing, 210029

    Recruiting

  • Clinical Trial Site

    Shenzhen Shi, 518053

    Recruiting

  • Clinical Trial Site

    Taiyuan, 030012

    Recruiting

  • Clinical Trial Site

    Wuhan, 430064

    Recruiting

  • Clinical Trial Site

    Xicheng, 100034

    Recruiting

  • Clinical Trial Site

    Yuanjiagang, 400016

    Recruiting

Other trials in China

Japan18 sites, 18 recruiting

  • Clinical Trial Site

    Bunkyō City, 113-8655

    Recruiting

  • Clinical Trial Site

    Fukuoka, 810-0001

    Recruiting

  • Clinical Trial Site

    Fukuoka, 812-8582

    Recruiting

  • Clinical Trial Site

    Kagawa, 761-0793

    Recruiting

  • Clinical Trial Site

    Kashihara, 634-8522

    Recruiting

  • Clinical Trial Site

    Kobe, 650-0017

    Recruiting

  • Clinical Trial Site

    Kumamoto, 860-8556

    Recruiting

  • Clinical Trial Site

    Kurume, 830-0011

    Recruiting

  • Clinical Trial Site

    Matsumoto-shi, 390-8621

    Recruiting

  • Clinical Trial Site

    Nagoya, 466-8560

    Recruiting

  • Clinical Trial Site

    Nankoku, 783-0043

    Recruiting

  • Clinical Trial Site

    Niigata, 951-8520

    Recruiting

  • Clinical Trial Site

    Okayama, 700-8558

    Recruiting

  • Clinical Trial Site

    Sapporo, 060-8543

    Recruiting

  • Clinical Trial Site

    Sapporo, 060-8648

    Recruiting

  • Clinical Trial Site

    Sendai, 980-8574

    Recruiting

  • Clinical Trial Site

    Suita, 564-8565

    Recruiting

  • Clinical Trial Site

    Tokyo, 160-8582

    Recruiting

Other trials in Japan

Spain18 sites, 18 recruiting

  • Clinical Trial Site

    A Coruña, 15006

    Recruiting

  • Clinical Trial Site

    Barcelona, 08035

    Recruiting

  • Clinical Trial Site

    Barcelona, 08036

    Recruiting

  • Clinical Trial Site

    Bilbao, 48013

    Recruiting

  • Clinical Trial Site

    El Palmar, 30120

    Recruiting

  • Clinical Trial Site

    Huelva, 21005

    Recruiting

  • Clinical Trial Site

    Jaén, 23007

    Recruiting

  • Clinical Trial Site

    L'Hospitalet de Llobregat, 8907

    Recruiting

  • Clinical Trial Site

    Lleida, 25198

    Recruiting

  • Clinical Trial Site

    Madrid, 28046

    Recruiting

  • Clinical Trial Site

    Madrid, 28222

    Recruiting

  • Clinical Trial Site

    Palma de Mallorca, 07198

    Recruiting

  • Clinical Trial Site

    Pamplona, 31008

    Recruiting

  • Clinical Trial Site

    Salamanca, 37007

    Recruiting

  • Clinical Trial Site

    Santiago de Compostela, 15706

    Recruiting

  • Clinical Trial Site

    Valencia, 46010

    Recruiting

  • Clinical Trial Site

    Valencia, 46026

    Recruiting

  • Clinical Trial Site

    Vigo, 36213

    Recruiting

Other trials in Spain

France16 sites, 16 recruiting

  • Clinical Trial Site

    Chambray-lès-Tours, 37170

    Recruiting

  • Clinical Trial Site

    Créteil, 94000

    Recruiting

  • Clinical Trial Site

    Dijon, 21000

    Recruiting

  • Clinical Trial Site

    La Tronche, 38700

    Recruiting

  • Clinical Trial Site

    Marseille, 13005

    Recruiting

  • Clinical Trial Site

    Martinique, 97261

    Recruiting

  • Clinical Trial Site

    Montpellier, 34295

    Recruiting

  • Clinical Trial Site

    Paris, 75015

    Recruiting

  • Clinical Trial Site

    Paris, 75018

    Recruiting

  • Clinical Trial Site

    Pessac, 33600

    Recruiting

  • Clinical Trial Site

    Reims, 51100

    Recruiting

  • Clinical Trial Site

    Rennes, 35000

    Recruiting

  • Clinical Trial Site

    Rouen, 76031

    Recruiting

  • Clinical Trial Site

    Saint-Herblain, 44093

    Recruiting

  • Clinical Trial Site

    Strasbourg, 67091

    Recruiting

  • Clinical Trial Site

    Toulouse, 31059

    Recruiting

Other trials in France

Italy15 sites, 15 recruiting

  • Clinical Trial Site

    Ancona, 60126

    Recruiting

  • Clinical Trial Site

    Bologna, 40138

    Recruiting

  • Clinical Trial Site

    Brescia, 25123

    Recruiting

  • Clinical Trial Site

    Florence, 50134

    Recruiting

  • Clinical Trial Site

    Forlì, 47121

    Recruiting

  • Clinical Trial Site

    Lecce, 73100

    Recruiting

  • Clinical Trial Site

    Milan, 20122

    Recruiting

  • Clinical Trial Site

    Naples, 80131

    Recruiting

  • Clinical Trial Site

    Padova, 35128

    Recruiting

  • Clinical Trial Site

    Pavia, 27100

    Recruiting

  • Clinical Trial Site

    Pisa, 56124

    Recruiting

  • Clinical Trial Site

    Rimini, 47923

    Recruiting

  • Clinical Trial Site

    Roma, 00168

    Recruiting

  • Clinical Trial Site

    Rome, 00161

    Recruiting

  • Clinical Trial Site

    Torino, 10126

    Recruiting

Other trials in Italy

Brazil12 sites, 12 recruiting

  • Clinical Trial Site

    Belo Horizonte, 30220-140

    Recruiting

  • Clinical Trial Site

    Campinas, 13083-888

    Recruiting

  • Clinical Trial Site

    Porto Alegre, 90035-903

    Recruiting

  • Clinical Trial Site

    Porto Alegre, 90560-032

    Recruiting

  • Clinical Trial Site

    Recife, 50070-480

    Recruiting

  • Clinical Trial Site

    Ribeirão Preto, 14026-900

    Recruiting

  • Clinical Trial Site

    Ribeirão Preto, 14051-140

    Recruiting

  • Clinical Trial Site

    Rio de Janeiro, 20551-030

    Recruiting

  • Clinical Trial Site

    Rio de Janeiro, 22280-020

    Recruiting

  • Clinical Trial Site

    Salvador, 40170-130

    Recruiting

  • Clinical Trial Site

    São Paulo, 04038-002

    Recruiting

  • Clinical Trial Site

    São Paulo, 05403-000

    Recruiting

Other trials in Brazil

Belgium11 sites, 11 recruiting

  • Clinical Trial Site

    Aalst, 9300

    Recruiting

  • Clinical Trial Site

    Bruges, 8000

    Recruiting

  • Clinical Trial Site

    Brussels, 1200

    Recruiting

  • Clinical Trial Site

    Dendermonde, 9200

    Recruiting

  • Clinical Trial Site

    Edegem, 2650

    Recruiting

  • Clinical Trial Site

    Genk, 3600

    Recruiting

  • Clinical Trial Site

    Ghent, 9000

    Recruiting

  • Clinical Trial Site

    Hasselt, 3500

    Recruiting

  • Clinical Trial Site

    Leuven, 3000

    Recruiting

  • Clinical Trial Site

    Liège, 4000

    Recruiting

  • Clinical Trial Site

    Roeselare, 8800

    Recruiting

Other trials in Belgium

Germany11 sites, 11 recruiting

  • Clinical Trial Site

    Berlin, 13353

    Recruiting

  • Clinical Trial Site

    Cologne, 50937

    Recruiting

  • Clinical Trial Site

    Dresden, 01307

    Recruiting

  • Clinical Trial Site

    Göttingen, 37075

    Recruiting

  • Clinical Trial Site

    Hanover, 30625

    Recruiting

  • Clinical Trial Site

    Heidelberg, 69120

    Recruiting

  • Clinical Trial Site

    Leipzig, 04103

    Recruiting

  • Clinical Trial Site

    Magdeburg, 39120

    Recruiting

  • Clinical Trial Site

    Munich, 81377

    Recruiting

  • Clinical Trial Site

    Münster, 48149

    Recruiting

  • Clinical Trial Site

    Würzburg, 97080

    Recruiting

Other trials in Germany

Argentina8 sites, 8 recruiting

  • Clinical Trial Site

    Buenos Aires, C1025ABI

    Recruiting

  • Clinical Trial Site

    Buenos Aires, C1093AAS

    Recruiting

  • Clinical Trial Site

    Buenos Aires, C1199ABB

    Recruiting

  • Clinical Trial Site

    Buenos Aires, C1428

    Recruiting

  • Clinical Trial Site

    Córdoba, X5016KET

    Recruiting

  • Clinical Trial Site

    Rosario, S2000DEJ

    Recruiting

  • Clinical Trial Site

    Rosario, S2000DSR

    Recruiting

  • Clinical Trial Site

    Rosario, S2000GAP

    Recruiting

Other trials in Argentina

Australia8 sites, 8 recruiting

  • Clinical Trial Site

    Adelaide, 5000

    Recruiting

  • Clinical Trial Site

    Bedford Park, 5042

    Recruiting

  • Clinical Trial Site

    Box Hill, 3128

    Recruiting

  • Clinical Trial Site

    Chermside, 4032

    Recruiting

  • Clinical Trial Site

    Darlinghurst, 2010

    Recruiting

  • Clinical Trial Site

    Joondalup, 6027

    Recruiting

  • Clinical Trial Site

    Liverpool, 2170

    Recruiting

  • Clinical Trial Site

    Westmead, 2145

    Recruiting

Other trials in Australia

Austria7 sites, 7 recruiting

  • Clinical Trial Site

    Braunau am Inn, 5280

    Recruiting

  • Clinical Trial Site

    Graz, 8036

    Recruiting

  • Clinical Trial Site

    Vienna, 1090

    Recruiting

  • Clinical Trial Site

    Vienna, 1100

    Recruiting

  • Clinical Trial Site

    Vienna, 1160

    Recruiting

  • Clinical Trial Site

    Vienna, 1210

    Recruiting

  • Clinical Trial Site

    Wels, 4600

    Recruiting

Other trials in Austria

Portugal7 sites, 7 recruiting

  • Clinical Trial Site

    Carnaxide, 2790-134

    Recruiting

  • Clinical Trial Site

    Creixomil, 4835-044

    Recruiting

  • Clinical Trial Site

    Leiria, 2410-197

    Recruiting

  • Clinical Trial Site

    Lisbon, 1169-024

    Recruiting

  • Clinical Trial Site

    Lisbon, 1649-035

    Recruiting

  • Clinical Trial Site

    Vila Real, 5000-508

    Recruiting

  • Clinical Trial Site

    Viseu, 3504-509

    Recruiting

Other trials in Portugal

United Kingdom6 sites, 6 recruiting

  • Clinical Trial Site

    Bellshill, ML4 3NJ

    Recruiting

  • Clinical Trial Site

    Birmingham, B15 2SQ

    Recruiting

  • Clinical Trial Site

    Cardiff, CF15 9SS

    Recruiting

  • Clinical Trial Site

    London, NW10 2PB

    Recruiting

  • Clinical Trial Site

    London, NW3 2QG

    Recruiting

  • Clinical Trial Site

    Manchester, M15 6SE

    Recruiting

Other trials in United Kingdom

Netherlands5 sites, 5 recruiting

  • Clinical Trial Site

    Eindhoven, 5623 EJ

    Recruiting

  • Clinical Trial Site

    Groningen, 9713 GZ

    Recruiting

  • Clinical Trial Site

    Maastricht, 6229 HX

    Recruiting

  • Clinical Trial Site

    Rotterdam, 3015 GD

    Recruiting

  • Clinical Trial Site

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

South Korea5 sites, 5 recruiting

  • Clinical Trial Site

    Incheon, 22332

    Recruiting

  • Clinical Trial Site

    Seoul, 03080

    Recruiting

  • Clinical Trial Site

    Seoul, 03722

    Recruiting

  • Clinical Trial Site

    Seoul, 06351

    Recruiting

  • Clinical Trial Site

    Seoul, 06591

    Recruiting

Other trials in South Korea

Switzerland5 sites, 5 recruiting

  • Clinical Trial Site

    Basel, 4051

    Recruiting

  • Clinical Trial Site

    Bern, 3010

    Recruiting

  • Clinical Trial Site

    Geneva, 1205

    Recruiting

  • Clinical Trial Site

    Lucerne, 6000

    Recruiting

  • Clinical Trial Site

    Sankt Gallen, 9007

    Recruiting

Other trials in Switzerland

Canada4 sites, 4 recruiting

  • Clinical Trial Site

    Calgary, T2N 4N1

    Recruiting

  • Clinical Trial Site

    London, N6A 5A5

    Recruiting

  • Clinical Trial Site

    Toronto, M4P 1E4

    Recruiting

  • Clinical Trial Site

    Vancouver, V6Z 1Y6

    Recruiting

Other trials in Canada

Czechia4 sites, 4 recruiting

  • Clinical Trial Site

    Brno, 602 00

    Recruiting

  • Clinical Trial Site

    Ostrava, 708-52

    Recruiting

  • Clinical Trial Site

    Prague, 128 21

    Recruiting

  • Clinical Trial Site

    Prague, 140 21

    Recruiting

Other trials in Czechia

Greece4 sites, 4 recruiting

  • Clinical Trial Site

    Athens, 115 27

    Recruiting

  • Clinical Trial Site

    Athens, 115 28

    Recruiting

  • Clinical Trial Site

    Heraklion, 714 09

    Recruiting

  • Clinical Trial Site

    Thessaloniki, 546 36

    Recruiting

Other trials in Greece

Israel4 sites, 4 recruiting

  • Clinical Trial Site

    Be’er Ya‘aqov, 70300

    Recruiting

  • Clinical Trial Site

    Haifa, 3109601

    Recruiting

  • Clinical Trial Site

    Jerusalem, 91120

    Recruiting

  • Clinical Trial Site

    Petah Tikva, 4941492

    Recruiting

Other trials in Israel

Taiwan4 sites, 4 recruiting

  • Clinical Trial Site

    New Taipei City, 220

    Recruiting

  • Clinical Trial Site

    Taichung, 40705

    Recruiting

  • Clinical Trial Site

    Taipei, 10002

    Recruiting

  • Clinical Trial Site

    Taipei, 112

    Recruiting

Other trials in Taiwan

Denmark3 sites, 3 recruiting

  • Clinical Trial Site

    Aarhus N, 8200

    Recruiting

  • Clinical Trial Site

    København Ø, 2100

    Recruiting

  • Clinical Trial Site

    Odense C, 5000

    Recruiting

Other trials in Denmark

New Zealand3 sites, 3 recruiting

  • Clinical Trial Site

    Auckland, 2025

    Recruiting

  • Clinical Trial Site

    Christchurch, 8011

    Recruiting

  • Clinical Trial Site

    Hamilton, 3204

    Recruiting

Other trials in New Zealand

Sweden3 sites, 3 recruiting

  • Clinical Trial Site

    Gothenburg, 413 45

    Recruiting

  • Clinical Trial Site

    Lund, 222 42

    Recruiting

  • Clinical Trial Site

    Solna, 171 76

    Recruiting

Other trials in Sweden

Turkey (Türkiye)3 sites, 3 recruiting

  • Clinical Trial Site

    Ankara, 06170

    Recruiting

  • Clinical Trial Site

    Antalya, 07070

    Recruiting

  • Clinical Trial Site

    Istanbul, 34093

    Recruiting

Other trials in Turkey (Türkiye)

Chile2 sites, 2 recruiting

  • Clinical Trial Site

    Santiago, 7500588

    Recruiting

  • Clinical Trial Site

    Santiago, 8320000

    Recruiting

Other trials in Chile

Hungary2 sites, 2 recruiting

  • Clinical Trial Site

    Balatonfüred, 8230

    Recruiting

  • Clinical Trial Site

    Budapest, 1085

    Recruiting

Other trials in Hungary

Ireland2 sites, 2 recruiting

  • Clinical Trial Site

    Dublin, D07 R2WY

    Recruiting

  • Clinical Trial Site

    Dublin, D08 NHY1

    Recruiting

Other trials in Ireland

Malaysia2 sites, 2 recruiting

  • Clinical Trial Site

    Kajang, 43000

    Recruiting

  • Clinical Trial Site

    Kuala Lumpur, 59100

    Recruiting

Other trials in Malaysia

Norway2 sites, 2 recruiting

  • Clinical Trial Site

    Ålesund, 6017

    Recruiting

  • Clinical Trial Site

    Lørenskog, 1478

    Recruiting

Other trials in Norway

Romania2 sites, 2 recruiting

  • Clinical Trial Site

    Bucharest, 022328

    Recruiting

  • Clinical Trial Site

    Cluj-Napoca, 400001

    Recruiting

Other trials in Romania

Hong Kong1 site, 1 recruiting

  • Clinical Trial Site

    Hong Kong, 999077

    Recruiting

Other trials in Hong Kong

Mexico1 site, 1 recruiting

  • Clinical Trial Site

    Tlalpan, 14080

    Recruiting

Other trials in Mexico

Poland1 site, 1 recruiting

  • Clinical Trial Site

    Lodz, 93-338

    Recruiting

Other trials in Poland

Slovakia1 site, 1 recruiting

  • Clinical Trial Site

    Košice, 040 11

    Recruiting

Other trials in Slovakia

About this study

Official title: TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Transthyretin-Mediated Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

The purpose of this study is to:

  • Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events
  • Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death
  • Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Being tested
Nucresiran, Sterile Normal Saline (0.9% NaCl)
Keywords
ATTR-CM, ATTR amyloidosis with cardiomyopathy, ATTR, Heriditary ATTR, hATTR, Wild-type ATTR, wATTR, Cardiomyopathy, Amyloidosis, TTR, Transthyretin, TTR-mediated amyloidosis, RNAi, RNAi therapeutic, TTR cardiomyopathy, V122i, TTR amyloidosis
Medical subject headings
Cardiomyopathies, Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NucresiranDrug

    Also called ALN-TTRSC04

    Nucresiran 300 mg administered SC q6M

  • Sterile Normal Saline (0.9% NaCl)Drug

    Sterile Normal Saline (0.9% NaCl) administered SC once q6M

Study groups in NCT07052903
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo administered subcutaneously (SC) once every 6 months (q6M) during the double-blind (DB) period, followed by nucresiran 300 mg administered SC q6M during the open-label extension (OLE) period.
Receives: Drug: Nucresiran; Drug: Sterile Normal Saline (0.9% NaCl)
Nucresiran 300 mgExperimentalParticipants will receive nucresiran 300 mg administered SC Q6M during the DB period, followed by nucresiran 300 mg administered SC q6M during the OLE period.
Receives: Drug: Nucresiran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits)

    All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model.

    Measured: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)

Secondary outcomes (4)

  1. Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality

    Measured: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)

  2. All-cause mortality

    Measured: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)

  3. Recurrent CV events (CV hospitalizations and urgent HF visits)

    Measured: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)

  4. Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS)

    The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary [OS]). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

    Measured: Baseline to Month 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start2 Jul 2025
  3. Primary completion28 May 2030 (estimated)
  4. Study completion30 Nov 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07052903
Sponsor's protocol ID
ALN-TTRSC04-003
Other IDs
2024-519917-72-00
Status last verified
Oct 2026
First submitted
30 Jun 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nucresiran and Sterile Normal Saline (0.9% NaCl) in people with Transthyretin Amyloidosis With Cardiomyopathy, run by Alnylam Pharmaceuticals at 266 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 266 sites in United States, China, Japan, Spain, France and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Information Line (1-877-ALNYLAM, clinicaltrials@alnylam.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits) (time frame: Baseline to end of double-blind period (estimated 32 months, maximum 5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07052903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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