🏛️ Verified NIH Record • Updated 2025-11-24

A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis (NCT06260709)

Open-label Extension Study of Long-term Safety and Efficacy of NNC6019-0001 in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR CM)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Novo Nordisk A/S

🩺 Plain-English Summary (8th-Grade Level)

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Arizona — Phoenix, Arizona

Age range: 18 Years to 85 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (35 Sites)

Showing the first 25 of 35 sites.

  • Mayo Clinic Arizona — Phoenix, Arizona
  • Cedars-Sinai Medical Center_Los Angeles — Los Angeles, California
  • Stanford Hlth Cre-Boswell Clin — Stanford, California
  • Mayo Clinic Jacksonville — Jacksonville, Florida
  • NW Univ-Bluhm Cardiovasc Inst — Chicago, Illinois
  • NW Univ-Bluhm Cardiovasc Inst — Evanston, Illinois
  • Univ of MD Schl of Med — Baltimore, Maryland
  • Mayo Clinic Rochester — Rochester, Minnesota
  • University of Calgary_Cardiology — Calgary, Alberta
  • Ctr for Cardiovascular Innovation — Vancouver, British Columbia
  • II. interni klinika VFN - Kardiologie a angiologie — Prague,
  • Ap-Hp-Hopital Henri Mondor — Créteil,
  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 — Toulouse,
  • UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie — Heidelberg,
  • Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie — Heidelberg,
  • LMU Klinikum München Klinik und Poliklinik 1 — München,
  • Uniklinik Münster, Klinik für Kardiologie I — Münster,
  • Universitätsklinikum Münster - Klinik für Kardiologie I — Münster,
  • Universitatsklinikum Wurzburg AöR — Würzburg,
  • Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz — Würzburg,
  • Fondazione CNR-Regione Toscana Gabriele Monasterio — Pisa, Pi
  • Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare — Pisa, Pi
  • Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo — Pavia, PV
  • Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology — Fukuoka,
  • Hiroshima University hospital, Cardiovascular Medicine — Hiroshima,

📞 Contact the Study Coordinator

Phone: (800) 664-4580

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗