RecruitingPHASE3INTERVENTIONAL

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

The CLEOPATTRA study is investigating a new medicine, Coramitug (also known as NNC6019-0001), for people who have heart failure due to a condition called transthyretin amyloid (ATTR) amyloidosis. This condition causes unusual protein deposits to build up in the heart, making it harder for the heart to work properly. The main goal of this study is to find out if Coramitug can help lower the risk of heart-related deaths and other serious heart problems. Participants in the study will be randomly assigned to receive either the new medicine or a placebo (a treatment that looks the same but contains no active medicine). It's important to know that everyone in the study will continue to receive the standard heart treatments their doctor recommends, alongside their study treatment. This is a Phase 3 study, meaning the medicine has already been tested in smaller groups and is now being tested on a larger scale to confirm its effectiveness and safety.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

1,280

Start

02 Oct 2025

Estimated completion

29 Jun 2029

Transthyretin Amyloid Cardiomyopathy (ATTR CM)

What is this study about?

The CLEOPATTRA study is focusing on a specific type of heart problem called transthyretin amyloid cardiomyopathy, often shortened to ATTR-CM. In this condition, a protein called transthyretin doesn't fold correctly and builds up in the heart. This build-up makes the heart muscle stiff and thick, which means it can't pump blood as effectively as it should. This can lead to symptoms of heart failure, such as breathlessness, tiredness, and swelling.

Researchers want to see if a new medicine, Coramitug, can make a difference for people living with ATTR-CM. The hope is that this medicine might be able to slow down or reduce the damage to the heart, potentially leading to fewer serious heart problems and perhaps even improving how well people live with the condition. By comparing Coramitug to a placebo, doctors can understand if the medicine itself is causing any positive changes, rather than other factors.

This study is important because ATTR-CM is a serious condition, and new treatments are always needed to help people manage it better. The results of this large study will help doctors decide if Coramitug could become a new option for treating ATTR-CM and improving the lives of those affected.

Key takeaways

The study tests a new medicine, Coramitug, for heart failure caused by ATTR amyloidosis.
It aims to reduce heart-related deaths and illness.
Participants will receive either Coramitug or a placebo.
All participants will continue their usual heart treatments.
It's a large-scale Phase 3 clinical trial.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You must have a confirmed diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM). This diagnosis means doctors have found that your heart has these specific protein deposits, making the walls of your heart thicker and causing heart failure.

Doctors will need to confirm your ATTR-CM diagnosis using specific tests. This could involve a biopsy (taking a small sample of heart tissue), or special scans of your heart, often combined with other blood or tissue tests. These tests help ensure that the heart problem is definitely caused by ATTR amyloid rather than something else.

There are two main types of ATTR-CM – wild-type and variant. The study is open to people with both types. About 15% of the people in the study are expected to have the variant type.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM)?
Have tests shown protein build-up in your heart causing thicker heart walls and heart failure?
Are you willing to undergo specific heart scans and other diagnostic tests if needed?

Answer every question to see your result.

What does participation involve?

Information about what taking part involves is not fully detailed in the provided summary. However, in most clinical trials like this, you would typically have regular visits to a clinic or hospital. These visits would include check-ups, blood tests, and possibly heart scans to monitor your condition and how the study medicine is affecting you. You would take either the study medicine (Coramitug) or the placebo as instructed, alongside your usual heart medications. The total duration of your participation and how many visits are needed would be explained in detail by the study team before you decide to join.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new medicine that could help your heart condition. However, it's also possible you could receive the placebo, which has no active medicine. As with any new medicine, there could be potential side effects or risks, which will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (290)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic Hospital
Verified postcode
Phoenix, United States· Not yet recruiting
University of California San Diego (UCSD) - Sulpizio Cardiovascular Center (SCVC)
Verified postcode
La Jolla, United States· Not yet recruiting
Keck School of Medicine USC - Healthcare Consultation Center 2 (HCCII)
Verified postcode
Los Angeles, United States· Not yet recruiting
Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute
Verified postcode
Los Angeles, United States· Not yet recruiting
UCI Medical Center
Verified postcode
Orange, United States· Not yet recruiting
Profound Research LLC at Southern California Heart Specialists
Verified postcode
Pasadena, United States· Recruiting
University of California, San Francisco Medical Center
Verified postcode
San Francisco, United States· Recruiting
NorthBay Clinical Research
Verified postcode
Santa Rosa, United States· Recruiting
Lucile Packard Children's Hospital
Verified postcode
Stanford, United States· Not yet recruiting
Yale University School of Medicine
Verified postcode
New Haven, United States· Recruiting
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States· Not yet recruiting
UF Health Heart and Vascular Hospital
Verified postcode
Gainesville, United States· Not yet recruiting

Common questions

What is ATTR amyloidosis?

It's a condition where an unusual protein called transthyretin builds up in your heart, making it harder for your heart to work well.

What is Coramitug?

Coramitug is the name of the new medicine being tested in this study to see if it can help people with heart failure due to ATTR amyloidosis.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare the real medicine's effects.

Will I still take my regular heart medicines?

Yes, everyone in the study will continue to receive their usual heart treatments as recommended by their doctor.

What happens if I want to leave the study?

You are free to leave the study at any time, for any reason, and your decision will not affect your future medical care.

How to find out more

Novo Nordisk

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

Always speak to your GP or specialist before deciding to take part in a study.