Coramitug for Transthyretin Amyloid Cardiomyopathy

(CLEOPATTRA Trial)

Recruiting at 270 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must be taking: Loop diuretics

Must not be taking: Positive inotropic medication

Disqualifiers: Non-ATTR amyloidosis, Severe valve disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 years

1280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new medicine NNC6019-0001 (also known as Coramitug) can reduce the risk of heart-related problems in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM), a condition affecting the heart. Participants will receive either the medicine or a placebo (a treatment with no active ingredients) while continuing their regular heart treatments. Suitable candidates for this trial include individuals with ATTR-CM experiencing heart issues such as shortness of breath or leg swelling. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop your current heart medications. You should continue your usual heart treatments as recommended by your doctor.

Is there any evidence suggesting that NNC6019-0001 is likely to be safe for humans?

In a previous study, patients who took NNC6019-0001, a new medicine for transthyretin amyloid cardiomyopathy (ATTR-CM), generally tolerated it well, with most not reporting serious side effects. Research has shown that this treatment is a humanized monoclonal antibody, which helps remove harmful proteins from the heart. This might explain its general tolerability. Another study found no major safety issues over a longer period, suggesting it is safe for many people. However, like any medicine, some might experience mild side effects. Always discuss potential risks with a doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Coramitug, or NNC6019-0001, is unique because it represents a new experimental approach to treating transthyretin amyloid cardiomyopathy (ATTR-CM), a condition typically managed by stabilizing the transthyretin (TTR) protein or reducing its production. Unlike current treatments like tafamidis, which stabilize the TTR protein, NNC6019-0001 is administered intravenously and is designed to target and remove the amyloid deposits that cause damage to the heart. This direct action on amyloid deposits offers a potentially transformative way to address the root cause of heart problems in ATTR-CM, which is why researchers are particularly excited about its potential impact.

What evidence suggests that NNC6019-0001 might be an effective treatment for ATTR-CM?

Research shows that NNC6019-0001, which participants in this trial may receive, may help treat transthyretin amyloid cardiomyopathy (ATTR-CM), a heart condition. In earlier studies, this antibody drug helped remove harmful protein deposits called amyloids from the heart and other organs. These amyloid deposits can damage tissues. By reducing these deposits, NNC6019-0001 might improve heart function and lower the risk of heart problems. Initial results from other trials showed that this treatment is safe and well-tolerated by patients, suggesting NNC6019-0001 could be an effective option for managing ATTR-CM. ^{3 6 7 8 9}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for individuals with transthyretin amyloid cardiomyopathy (ATTR-CM), a condition that affects the heart. Participants must be currently receiving standard treatments for heart failure and are willing to add either the study drug or placebo to their regimen.

Inclusion Criteria

I am either male or female.

Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeters (mm)

I am 18 years old or older.

Exclusion Criteria

Known or suspected hypersensitivity to study intervention(s) or related products

Current or previous participation 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NNC6019-0001 or placebo intravenously, alongside their standard of care treatments

Up to 4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NNC6019-0001

Trial Overview The CLEOPATTRA study is testing NNC6019-0001, a new medication, against a placebo. The goal is to see if it can lower the risk of heart-related death and illness in ATTR-CM patients. Treatment assignment is random.

How Is the Trial Designed?

Group I: NNC6019-0001 Experimental Treatment 1 Intervention

Participants will receive NNC6019-0001 intravenously (IV). Participants will also have the option to continue any Standard of care (SoC) treatments as recommended by their medical health professional.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to NNC6019-0001 IV. Participants will also have the option to continue any SoC treatments as recommended by their medical health professional.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06260709

NCT06260709 | A Research Study to Look at Long-term ... 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 ...

2. sciencehub.novonordisk.com sciencehub.novonordisk.com/content/sciencehub/global/en/congresses-and-scientific-publications/congresses/aha2025/fontana.html

AHA 2025 - Primary results from the phase 2 randomized ... Primary results from the phase 2 randomized, placebo controlled, blinded trial of the monoclonal antibody coramitug in transthyretin amyloid cardiomyopathy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379670/

Current and Future Treatment Landscape of Transthyretin ... Preclinical studies showed effective amyloid clearance across multiple organs, including the heart, liver, and spleen, with sustained phagocytic ...

4. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/NN6019-4940

ATTR CM: Efficacy and Safety of NNC6019-0001 in ... The purpose of this study is to determine whether an investigational drug called NNC6019-0001 can be used to treat people with transthyretin (TTR)

5. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN6019-4958.html

A Research Study to Look at the Effects of Treatment ... 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 ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.077304

Coramitug, a Humanized Monoclonal Antibody for the ... Coramitug is a humanized monoclonal antibody that targets misfolded transthyretin, designed to promote clearance of transthyretin amyloid ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05442047

NCT05442047 | A Research Study to Look at How a New ... This study is testing a potential new medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis.

8. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/NN6019-7565

Long-Term Safety and Efficacy of NNC6019-0001 in ... The purpose of this study is to evaluate the long-term safety and effectiveness of a medicine called NNC6019-0001 in people who have heart failure.

9. academic.oup.com academic.oup.com/eurheartj/article/43/Supplement_2/ehac544.1767/6745267

NNC6019–0001, a humanized monoclonal antibody, in ... This is a randomized, double-blind, placebo-controlled trial recruiting 99 patients with hereditary or wild-type ATTR-CM.