CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis
CLEOPATTRA: Effects of NNC6019-0001 Versus Placebo on Cardiovascular Outcomes in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether coramitug (NNC6019-0001) can lower the risk of heart-related death and illness in adults with ATTR-CM, a buildup of a protein called transthyretin in the heart that causes heart failure. By chance, participants get either coramitug or a placebo, a treatment with no active medicine. Everyone keeps taking their usual heart treatments.
This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older. People of any sex may join.
- Have confirmed ATTR-CM, either inherited or not inherited, with protein buildup in the heart.
- Have the protein buildup confirmed by heart tissue testing or specific scans with other tissue, blood, or urine tests.
- Have a heart ultrasound showing that the wall between the heart’s main pumping chambers is at least 12 millimeters thick.
- Have long-term heart failure, with a past hospital stay for heart failure or signs of fluid buildup or high pressure inside the heart.
- Be expected to have stable heart medicines for 4 weeks before treatment is assigned: no changes in medicine types or dose changes over 50%. Water pills are an exception.
- Walk more than 50 meters during a 6-minute walk test at screening.
Who can't join
- Have a known or suspected allergy to the study treatment or related products, or have received an active experimental ATTR-clearing drug or ATTR gene-editing treatment in a study.
- Have another type of amyloidosis, known amyloid buildup in the lining around the brain and spinal cord, or multiple myeloma, a blood cancer.
- Have heart failure mainly caused by something other than ATTR-CM; take medicine that increases the force of heartbeats; have severe, uncorrected left-sided heart valve disease affecting blood flow; or have a heart pumping measure below 30%.
- Be in the hospital now or have been hospitalized within 14 days before screening.
- Within 60 days before screening, have had a heart attack or other sudden heart blood-flow problem, unstable chest pain, stroke or mini-stroke, a procedure to restore heart blood flow, a heart device placed, heart valve repair, or major surgery.
- Have had a solid organ transplant or plan to have one during the study.
- Have had cancer within 3 years before screening, except certain skin, early-stage cervical, or prostate cancers allowed by the study.
- Have bilirubin, a substance measured in blood, more than 3 times the upper normal limit; have kidney function below the study’s limit; or need dialysis, a treatment that filters the blood.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Male or female. 2. Age 18 years or above at the time of signing the informed consent. 3. Have an established diagnosis of ATTR-CM (wild-type ATTR \[ATTRwt\] or variant ATTR \[ATTRv\]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF. Note: Target ATTRv recruitment is approximately 15 percent of the study population. a. Cardiac amyloid infiltration demonstrated by: i. Cardiac biopsy positive for TTR amyloid, OR ii. Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) nuclear medicine imaging with single-photon emission computed tomography (SPECT) or SPECT/CT (preferably) combined with an extracardiac biopsy positive for TTR amyloid, OR iii. Grade 2 or 3 cardiac uptake at PYP/DPD/HMDP nuclear medicine imaging with SPECT or SPECT/CT (preferably) combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \& UPIE)/or mass spectrometry based methods including mass fixation). Notes: * Non-invasive diagnostic pathway will be confirmed by a centralised expert review. * Bone tracer nuclear medicine imaging with SPECT or SPECT/CT (preferably) will be conducted using 99m-technetium (Tc)-labelled pyrophosphate (99mTc-PYP), 99mTc-labelled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD), or 99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP). * The eGFR adjusted acceptable serum free light chain ratio. * Patients with Grade 2 or 3 cardiac uptake at PYP/DPD/HDMP nuclear imaging with SPECT or SPECT/CT (preferably) and evidence of monoclonal gammopathy of undetermined significance (MGUS; based on serum and urine protein electrophoresis and serum free light chains) will require endomyocardial biopsy with typing using mass spectrometry or immunohistochemistry to confirm presence of TTR protein in tissue. * Timing of serum free light chain ratio, SPIE, UPIE and mass spectrometry-based methods including mass fixation should be within 12 months of SPECT or SPECT/CT nuclear imaging. b. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm). c. Chronic HF (New York Heart Association \[NYHA\] Class I-IV): i. At least 1 documented hospitalisation for HF, OR ii. History of HF manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath, signs of pulmonary congestion on x-ray or auscultation, or peripheral oedema that required or requires ongoing treatment with a diuretic). 4. Expected to be on stable cardiovascular medical therapy (defined as no greater than 50 percent dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit. 5. Completed more than 50 meters on the 6MWT at screening. Exclusion Criteria: 1. Known or suspected hypersensitivity to study intervention(s) or related products. 2. Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy. 3. Total bilirubin greater than 3 times the upper limit of normal (ULN) at screening. 4. Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis, or multiple myeloma. 5. HF not primarily caused by ATTR-CM (e.g., due to hypertension, valvular heart disease, or ischemic heart disease in the opinion of the investigator). 6. Currently hospitalised or hospitalised within 14 days prior to screening. 7. Currently treated with positive inotropic medication. 8. Uncorrected, severe, haemodynamically significant, left-sided heart valve disease. 9. Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 60 days of screening. 10. Prior solid organ transplant or planned solid organ transplant during the study. 11. Left ventricular ejection fraction (LVEF) less than 30 percent as assessed by centralised review of echocardiography. 12. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, carcinoma in situ/high-grade prostatic intraepithelial neoplasia \[PIN\], low-risk prostate cancer, or on stable therapy for prostate cancer) within 3 years before screening. 13. End-stage renal disease (estimated glomerular filtration rate \[eGFR\] less than 15 mL/min/1.73 m\^2 at screening, or chronic/intermittent haemodialysis or peritoneal dialysis).
Study sites (63)
AZ
- Mayo Clinic Hospital · Phoenix, AZ 85054More trials in Phoenix
CA
- University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC) · La Jolla, CA 92037More trials in La Jolla
- Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII) · Los Angeles, CA 90033More trials in Los Angeles
- Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute · Los Angeles, CA 90048More trials in Los Angeles
- UCI Medical Center · Orange, CA 92868More trials in Orange
- Profound Research LLC at Southern California Heart Specialists · Pasadena, CA 91105More trials in Pasadena
- University of California, San Francisco Medical Center · San Francisco, CA 94143More trials in San Francisco
- NorthBay Clinical Research · Santa Rosa, CA 95405More trials in Santa Rosa
- Lucile Packard Children's Hospital · Stanford, CA 94305More trials in Stanford
CT
- Yale University School of Medicine · New Haven, CT 06510More trials in New Haven
DC
- MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center · Washington D.C., DC 20010-3017More trials in Washington D.C.
FL
- UF Health Heart and Vascular Hospital · Gainesville, FL 32608More trials in Gainesville
GA
- Northeast Georgia Heart Center, Pc (Nghc) · Gainesville, GA 30501-3466More trials in Gainesville
HI
- The Queen's Medical Center · Honolulu, HI 96813More trials in Honolulu
IL
- Northwestern University Clinical and Translational Sciences Institute · Chicago, IL 60611More trials in Chicago
- The University of Chicago Medicine · Chicago, IL 60637More trials in Chicago
- Endeavor Health - Glenbrook Hospital · Glenview, IL 60026More trials in Glenview
IN
- Indiana University (IU) Health - Methodist Professional Center II · Indianapolis, IN 46202More trials in Indianapolis
LA
- LCMC - LSU University Medical Center New Orleans LCMC Center · New Orleans, LA 70112More trials in New Orleans
MA
- Tufts Medical Center · Boston, MA 02111More trials in Boston
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
MD
- University of Maryland Medical Center (UMMC) - Children's Hospital (UMCH) · Baltimore, MD 21201More trials in Baltimore
- John Hopkins Medicine · Baltimore, MD 21287More trials in Baltimore
MI
- University of Michigan Health System · Ann Arbor, MI 48109More trials in Ann Arbor
- Henry Ford Health · Detroit, MI 48202More trials in Detroit
- Profound Research · Farmington Hills, MI 48334More trials in Farmington Hills
MN
- Mayo Clinic · Rochester, MN 55905More trials in Rochester
MO
- Saint Luke's Hospital of Kansas City · Kansas City, MO 64111More trials in Kansas City
- Saint Louis University · St Louis, MO 63110More trials in St Louis
- Washington University School of Medicine · St Louis, MO 63110More trials in St Louis
MS
- Cardiology Associates Research, LLc · Tupelo, MS 38801More trials in Tupelo
NC
- Duke University Health System · Durham, NC 27750More trials in Durham
NE
- University of Nebraska Medical Center · Omaha, NE 68198More trials in Omaha
NY
- North Shore University Hospital, Northwell Health · Manhasset, NY 11030More trials in Manhasset
- NYU Langone Health · New York, NY 10016More trials in New York
- Weill Medical College Of Cornell University · New York, NY 10021More trials in New York
- Mount Sinai Medical Center · New York, NY 10029More trials in New York
- Columbia University Medical Center · New York, NY 10032More trials in New York
- Laurelton Heart Specialist, PC · Rosedale, NY 11422More trials in Rosedale
- Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) · The Bronx, NY 10467-2401More trials in The Bronx
OH
- The Carl and Edyth Lindner-Center for Research and Education at The Christ Hospital · Cincinnati, OH 45219-2906More trials in Cincinnati
- Cleveland Clinic - Taussig Cancer Institute · Cleveland, OH 44195More trials in Cleveland
- OhioHealth Riverside Methodist Hospital · Columbus, OH 43214More trials in Columbus
OR
- Oregon Health and Science University · Portland, OR 97239More trials in Portland
PA
- Jefferson Health · Abington, PA 19001More trials in Abington
- Lehigh Valley Hospital · Allentown, PA 18103More trials in Allentown
- Penn State Milton S.Hershey Medical Center - Penn State Hershey Cancer Institute · Hershey, PA 17033More trials in Hershey
- The Heart Group of Lancaster General Health · Lancaster, PA 17603More trials in Lancaster
- Penn Medicine: University of Pennsylvania Health System · Philadelphia, PA 19104More trials in Philadelphia
SC
- Prisma Health · Greenville, SC 29605More trials in Greenville
TN
- Saint Thomas Health · Nashville, TN 37205More trials in Nashville
TX
- Ascension Texas Cardiovascular Research Institute · Austin, TX 78705More trials in Austin
- St. Davids Heart and Vascular · Austin, TX 78751More trials in Austin
- Baylor Scott & White Research Institute - Annette C. and Harold C. Simmons Transplant Institute · Dallas, TX 75246More trials in Dallas
- University of Texas Southwestern Medical Center · Dallas, TX 75390-9045More trials in Dallas
- Baylor St. Luke Medical Center · Houston, TX 77030More trials in Houston
- Houston Methodist Hospital · Houston, TX 77030More trials in Houston
- Baylor Scott & White The Heart Hospital · Plano, TX 75093More trials in Plano
UT
- Intermountain Healthcare - Intermountain Medical Center - C. DuWayne Schmidt Chest Clinic · Murray, UT 84107More trials in Murray
VA
- Inova Fairfax Hospital - Inova Heart and Vascular Institute · Falls Church, VA 22042More trials in Falls Church
- Sentara Cardiovascular Research Institute · Norfolk, VA 23507More trials in Norfolk
- Virginia Commonwealth University Medical Center · Richmond, VA 23298More trials in Richmond
WA
- Providence Sacred Heart Medical Center and Children's Hospital · Spokane, WA 99201More trials in Spokane