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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT07207811•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female.
•Age 18 years or above at the time of signing the informed consent.
•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.
•1. Cardiac amyloid infiltration demonstrated by:
•* Cardiac biopsy positive for TTR amyloid, OR
•* Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)/diphosphono-1,2-propanodicarboxylic acid (DPD)/ hydroxymethylene diphosphonate (HMDP) scintigraphy with single-photon emission computed tomography (SPECT/CT) combined with an extracardiac biopsy positive for TTR amyloid, OR
•* Grade 2 or 3 cardiac uptake at PYP/DPD/HMDP scintigraphy with SPECT/CT combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \& UPIE).
•Notes:
•* Non-invasive diagnostic pathway will be confirmed by a centralised expert review.
+7 more criteria

Exclusion Criteria

•Known or suspected hypersensitivity to study intervention(s) or related products.
•Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.
•Total bilirubin greater than 3 times the upper limit of normal (ULN) at screening.
•Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis, or multiple myeloma.
•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).
•Currently hospitalised or hospitalised within 14 days prior to screening.
•Currently treated with positive inotropic medication.
•Uncorrected, severe, haemodynamically significant, left-sided heart valve disease.
•Note: Pre-existing echocardiogram up to 2 years old may be used.
•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.
+4 more criteria

Locations (285)

Mayo Clinic Hospital

Phoenix, Arizona, United States

University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC)

La Jolla, California, United States

Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)

Los Angeles, California, United States

Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

UCI Medical Center

Orange, California, United States

Profound Research LLC at Southern California Heart Specialists

Pasadena, California, United States

University of California, San Francisco Medical Center

San Francisco, California, United States

Northbay Cardiology Inc.

Santa Rosa, California, United States

Lucile Packard Children's Hospital

Stanford, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Key Dates

Start Date

October 2, 2025

Primary Completion Date

June 29, 2029

Completion Date

June 29, 2029

Last Updated

March 19, 2026

Enrollment

1,280

ESTIMATED participants

Conditions

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Interventions

NNC6019-0001

DRUG

Placebo (NNC6019-0001)

DRUG

Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178 clinicaltrials@novonordisk.com