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 | Active Not Recruiting Phase 2 FDA Drug

• 4 other identifiers: NN6019-75652022-502605-15-00U1111-1284-5820jRCT2071240078
• Study Type: interventional
• Target: 80
• Locations: 10 countries
• Sites: 38

Brief Summary

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).

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Adverse Events (TEAEs)

  Measured as events.

  From baseline (week 0) up to visit 39 (week 156)

Secondary Outcomes (6)

• Change in 6-Minute Walk Test (6MWT)

  From baseline (week 0) to visit 28 (week 104)

• Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)

  From baseline (week 0) to visit 28 (week 104)

• Change in Myocardial Extracellular Volume (ECV)

  From baseline (week 0) to visit 28 (week 104)

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)

  From baseline (week 0) to visit 28 (week 104)

• Change in Troponin I

  From baseline (week 0) to visit 28 (week 104)

Study Arms (1)

NNC6019-0001

EXPERIMENTAL

Participants will receive NNC6019-0001 intravenously every 4 weeks added to the standard of care until Week 140.

Drug: NNC6019-0001

Interventions

NNC6019-0001 DRUG

Intravenous NNC6019-0001 every 4 weeks added to the standard of care until Week 140.

NNC6019-0001

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16.
• Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.

You may not qualify if:

• A prior solid organ transplant.
• Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
• Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
• Body weight greater than (\>) 120 kilograms (kg) (264.6 pounds \[lb\]) at screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (38)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Cedars-Sinai Medical Center_Los Angeles

Los Angeles, California, 90048, United States

Location

Stanford Hlth Cre-Boswell Clin

Stanford, California, 94305, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

NW Univ-Bluhm Cardiovasc Inst

Chicago, Illinois, 60611, United States

Location

NW Univ-Bluhm Cardiovasc Inst

Evanston, Illinois, 60208, United States

Location

Univ of MD Schl of Med

Baltimore, Maryland, 21201, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

University of Calgary_Cardiology

Calgary, Alberta, T2N 4Z6, Canada

Location

Ctr for Cardiovascular Innovation

Vancouver, British Columbia, V5Z 1M9, Canada

Location

II. interni klinika VFN - Kardiologie a angiologie

Prague, 12808, Czechia

Location

Ap-Hp-Hopital Henri Mondor

Créteil, 94000, France

Location

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

Toulouse, 31059, France

Location

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

Toulouse, 31059, France

Location

UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie

Heidelberg, 69120, Germany

Location

Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie

Heidelberg, 69120, Germany

Location

LMU Klinikum München Klinik und Poliklinik 1

München, 81377, Germany

Location

Uniklinik Münster, Klinik für Kardiologie I

Münster, 48149, Germany

Location

Universitätsklinikum Münster - Klinik für Kardiologie I

Münster, 48149, Germany

Location

Universitatsklinikum Wurzburg AöR

Würzburg, 97078, Germany

Location

Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz

Würzburg, 97078, Germany

Location

Fondazione CNR-Regione Toscana Gabriele Monasterio

Pisa, Pi, 56124, Italy

Location

Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare

Pisa, Pi, 56124, Italy

Location

Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

Hospital of the University of Occupational and Environmental Health, Cardiology, Nephrology

Fukuoka, 807-8556, Japan

Location

Hiroshima University hospital, Cardiovascular Medicine

Hiroshima, 734-8551, Japan

Location

Hiroshima University hospital_Cardiovascular Medicine

Hiroshima, 734-8551, Japan

Location

Kumamoto University Hospital, Cardiovascular Medicine

Kumamoto-shi, Kumamoto, 860-8556, Japan

Location

Shinshu University Hospital, Department of Neurology

Nagano, 390-8621, Japan

Location

Nagasaki University Hospital, Cardiovascular Medicine

Nagasaki, 852-8501, Japan

Location

Okayama University Hospital_Cardiovascular Medicine

Okayama-shi, Okayama, 700-8558, Japan

Location

UMC Groningen

Groningen, 9713 GZ, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Hospital da Senhora da Oliveira - Guimarães

Guimarães, 4835-044, Portugal

Location

ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães

Guimarães, 4835-044, Portugal

Location

ULS De Tras-Os-Montes E Alto Douro E.P.E. - Unidade Hospitalar de Vila Real

Vila Real, 5000-508, Portugal

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 9, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (7); CA (2); US (8); FR (3); JP (7); ES (1); IT (3); PT (3); NL (3); CZ (1)