Are you living with transthyretin amyloid cardiomyopathy (ATTR-CM)?
The CLEOPATTRA study may be able to help reduce amyloid deposits in the heart and ATTR-CM symptoms.
Transthyretin amyloid cardiomyopathy, or ATTR-CM, is a rare, progressive, and potentially fatal heart condition where misfolded transthyretin (TTR) protein builds up in the heart muscle, leading to heart failure.
Living with ATTR-CM can feel overwhelming and limiting. Current treatments mainly focus on preventing new protein deposits in the heart but do not remove the deposits that have already formed. This gap in treatment highlights the pressing need for therapies that not only help manage the various symptoms more effectively but also aim to improve your overall quality of life.
But there’s hope. Together, we can work toward potential solutions, which is why we invite you to consider the CLEOPATTRA study that is testing a study medication for ATTR-CM that can also be used alongside standard-of-care treatments.
The CLEOPATTRA study is testing a study medication called NNC6019-0001, an antibody treatment that could potentially reduce or even reverse amyloid deposits in the heart. The purpose of this study is to learn about the effectiveness of NNC6019-0001 in reducing deaths and illness related to the heart and blood circulation and to see how well it is tolerated. The study will also look at whether the study medication increases the ability to walk and quality of life. Earlier trials showed this treatment helped improve heart failure symptoms in people with ATTR-CM.
This is the first study medication designed to be taken alongside standard-of-care treatments for ATTR-CM. During the study, you may continue any treatments recommended by your doctor and healthcare team, including general heart failure management.
Participants may receive:
Access to a study medication that may or may not help people with more advanced ATTR-CM
Close care and specialized monitoring in addition to patients being able to continue their current standard of care
Compensation for their time and travel for patients and their caregivers
You may be able to join if you:
- Are at least 18 years old
- Have been diagnosed with ATTR-CM, either hereditary (ATTRv) or wild-type (ATTRwt)
- Have protein buildup and thickening in your heart and heart failure symptoms
- Have been on a stable heart medication regimen (except for diuretics) for at least 4 weeks when you receive the first dose of study medication
- Can walk more than 50 meters (164 feet) during a 6-minute walk test
You will need to meet other requirements to join the CLEOPATTRA study.
Contact one of our study doctors to see if you meet all the requirements. The study doctors are looking for a diverse population to be included in this clinical trial.
The total duration of your participation in the CLEOPATTRA study will vary depending on when you enroll and includes:
- Screening period: Up to 6 weeks (or up to 12 weeks if taking part in the cardiac imaging substudy)
- Treatment period: Frequent study visits. The study doctor will explain the visit schedule in more detail during screening
- Follow-up: 16 weeks after you stop taking the study medication or placebo
If you are eligible and decide to take part in the CLEOPATTRA study, you will be assigned randomly (as if flipping a coin) to receive either the study medication, NNC6019-0001, or placebo, which looks like the study medication but contains no active ingredients. Using a placebo in a study is the best way to find out if the treatment being tested works better than receiving no treatment or standard-of-care treatment.
Both NNC6019-0001 and the placebo are given through an infusion (into a vein in your arm). During the study, you will also undergo genetic testing (blood test) if you have not previously had such testing.
Cardiac magnetic imaging substudy: The CLEOPATTRA study includes a recommended but optional cardiac imaging study in some countries, using cardiac magnetic resonance imaging, to see how well the study medication reduces protein buildup in the heart. This involves using a noninvasive imaging technique to view the structure and function of your heart. This substudy requires a separate consent, which your study doctor will go over with you should you decide to join.
Participants must meet additional criteria to take part in this optional substudy.
What is cardiac magnetic resonance (CMR) imaging? Cardiac magnetic resonance (CMR) is a noninvasive imaging procedure that uses a strong magnetic field to create detailed images of your heart. These images help doctors see how your heart is functioning and assess the presence of amyloid deposits, which are common in ATTR-CM.
- CMR imaging does not involve radiation exposure.
- Each CMR procedure involves use of a contrast medium, a special dye that helps to provide detailed imaging of the heart.
- The contrast medium will be injected into an arm vein where it travels to the heart.
- The contrast involved is specific to MR imaging and not related to iodinated contrast used for other kinds of imaging studies.
Why is it part of this study? The CMR imaging will help researchers measure the extent and nature of amyloid deposits in the heart. The results from this imaging will also help determine how well the study medication, NNC6019-0001, is working in participants with ATTR-CM.
Who is eligible to take part in the substudy?
You may be eligible to take part in the substudy if you:
- Do not have a pacemaker or implantable cardioverter-defibrillator (ICD)
- Do not have any allergies to the contrast used in the imaging or reactions to agents that contain gadolinium
- Do not have an estimated glomerular filtration rate of <30 ml/min/1.73 m²
What is the potential benefit of participating in the substudy? Participating in the CMR substudy gives you a unique opportunity to gain more detailed insights into your heart health. The imaging results may help you and your doctor better understand the progression of your condition and how it responds to treatment. This could provide valuable information for your overall health management.
Do I have to participate in the substudy? No, participation in the CMR substudy is entirely optional. You can choose whether or not to participate, and if you decide to take part, you are free to leave the substudy at any time for any reason, without any impact on your participation in the main CLEOPATTRA study.
- The CMR imaging will be used to detect the extent and nature of amyloid deposits in ATTR-CM.
- CMR imaging does not involve radiation exposure.
- The imaging results can help determine whether the study medication, NNC6019-0001, is affecting your health.
- Your participation in the CMR imaging substudy is entirely up to you. You can leave the substudy at any time and for any reason.
Please enter your city or your ZIP code / postal code to find a study center near you.
Please select the study center that is most convenient for you.
Take the questionnaire
The following questions are designed to help find out whether a potential participant may be eligible for participation in the CLEOPATTRA study.
A clinical trial is a research study that tests potential new treatment options for patients. Most medications, treatments, medical devices, and tools used in the medical field today started in a clinical trial. Regulatory agencies must review the results from clinical trials before approving a medication, treatment, or medical device. Participants in clinical trials must meet specific criteria to join and can withdraw from a study at any time.
Frequently asked questions
The CLEOPATTRA study is testing a study medication called NNC6019-0001 to see what effect it may have on your ATTR-CM and symptoms and health-related events.
This is the first study medication designed to be taken alongside standard-of-care treatments for ATTR-CM. During the study, you may continue any treatments recommended by your doctor and healthcare team, including general heart failure management.
The total duration of your participation in the CLEOPATTRA study will vary depending on when you enroll. It includes up to 6 weeks of screening (or up to 12 weeks if taking part in the cardiac imaging substudy), followed by a treatment period where you will receive infusions. After completing the study treatment or if you leave early, you will have a follow-up visit 16 weeks after receiving the last dose of study medication or placebo.
Cardiac Magnetic Resonance Imaging Substudy
As a part of the CLEOPATTRA study, you may have the opportunity to take part in an optional cardiac imaging substudy (in selected countries), which involves using a noninvasive imaging technique to view the structure and function of your heart.
Joining the CLEOPATTRA study is completely up to you. Deciding not to take part will not affect your usual medical care now or in the future. If you take part, you can decide to leave the study at any time and for any reason.
- Hypersensitivity reactions - allergic-like responses by the immune system, such as rash, itching, or swelling
- Myocardial inflammation - swelling or irritation in the heart muscle
- Cardiac arrhythmia - irregular or abnormal heartbeat
You may or may not benefit from taking part in this study or taking the study medicine.
If you join the CLEOPATTRA study, you will receive at no cost:
- The study medication, NNC6019-0001, or placebo
- Support and close medical care from your study team
- Reimbursement for study-related expenses (travel and meals, for participants and caregivers)
- The opportunity to help us learn more about the study medication, which may help others with ATTR-CM in the future
During a clinical study, you may receive the study medication that is being studied. This will be done at scheduled times and can occur only once or multiple times throughout the study, depending on the medication. If you participate, you may also have the following procedures done to track your health: vital signs, blood work, physical exams, or other types of assessments that are necessary to gather the required information about the study medication. In some studies, you may not receive the study medication but instead receive a placebo. All study volunteers are always closely watched by clinic staff and the medical team to ensure their safety. During the CLEOPATTRA study, you will also undergo genetic testing (blood test) if you have not previously had such testing.
Placebo: A placebo looks like the study medication being tested, but it doesn’t have any active ingredients. In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment or standard-of-care treatment.
Novo Nordisk (the study sponsor) will reimburse all study participants and their caregivers for study-related travel and expenses. For more information, please speak with a member of the study team during your study visits.
There are many reasons to take part in clinical research. For starters, it allows participants to play a more proactive role in their own health by receiving a potential treatment for an ongoing disease or condition. Participants also play an important part in bringing much-needed medications to market, benefiting thousands of people who also have the disease or condition.
We are dedicated to enrolling participants from a wide range of backgrounds in our clinical trial. By ensuring diversity in our participant population, we aim to gather comprehensive data that will help make medical advancements more accessible and relevant to all communities.
Every clinical trial must be reviewed, and is continually watched, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
Novo Nordisk is responsible for conducting this clinical study.
