mRNA-0184 for Heart Failure

No longer recruiting at 15 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ModernaTX, Inc.

Must be taking: Cardiovascular medications

Disqualifiers: Decompensated HF, Angina, Severe pulmonary disease, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mRNA-0184 to determine its safety and tolerability for people with heart failure. Participants will receive either a single dose, up to four doses of the treatment, or a placebo for comparison. The trial targets individuals diagnosed with heart failure who manage it with consistent medication. It is not suitable for those recently hospitalized for heart issues or those with severe heart-related conditions. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial requires that you have been on a stable regimen of heart medications for at least 4 weeks before joining, so you should not stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that mRNA-0184 is a new treatment aimed at addressing heart failure. This treatment uses a special type of messenger RNA (mRNA) packed in tiny particles, which the body reads to produce a beneficial protein. Previous studies have primarily assessed the safety and tolerability of this treatment in humans.

Since mRNA-0184 remains in early testing stages, information about its safety in humans is limited. However, similar mRNA-based treatments have been tested before and are generally well-tolerated. In those cases, common reactions included mild side effects like soreness at the injection site or mild flu-like symptoms.

As this study is in its early phases, it focuses heavily on safety and ensuring participants can tolerate the treatment without serious issues. Researchers are exercising caution and closely monitoring how patients respond to different doses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Researchers are excited about mRNA-0184 for heart failure because it represents a new approach using mRNA technology. Unlike traditional heart failure treatments, which often involve medications like beta-blockers and ACE inhibitors that help manage symptoms and slow the progression, mRNA-0184 works by delivering specific genetic instructions to cells, potentially helping the heart heal and function better. This innovative mechanism could lead to more effective management of heart failure by addressing the underlying cellular processes, offering hope for improved outcomes where existing treatments may fall short.

What evidence suggests that mRNA-0184 might be an effective treatment for heart failure?

Research shows that mRNA-0184 is designed to help the body produce a protein similar to the hormone relaxin, which may reduce stress on the heart. Studies have found that mRNA-0184 includes a modification that extends the protein's activity in the body. This approach holds promise for improving heart function and alleviating heart failure symptoms. Early tests and lab studies suggest potential benefits for individuals with heart issues. However, limited information from human studies prevents confirmation of mRNA-0184's effectiveness in treating heart failure. Participants in this trial will receive either mRNA-0184 or a placebo, enabling researchers to evaluate its effectiveness and safety. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with heart failure who have been on stable heart medication for at least 4 weeks. They should have a left ventricular ejection fraction between 35% and <50%, fall under NYHA HF Class I or II, and not be hospitalized for cardiovascular reasons recently. People can't join if they've had recent COVID-19 vaccination, angina symptoms, severe allergies to the drug's components, other clinical study participation recently, uncontrolled diabetes, certain heart diseases or severe lung problems.

Inclusion Criteria

Your heart's pumping function is between 35% and 50%, as measured by a heart imaging test within the past 3 months.

My heart failure is mild to moderate.

I have been officially diagnosed with heart failure.

Exclusion Criteria

History of hypersensitivity to any components of the investigational product (IP)

I was hospitalized for heart-related issues within the last 3 months.

I have had a fast heartbeat due to irregular rhythms in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SAD Stage

Participants receive a single dose of mRNA-0184

Duration not specified

MAD Stage

Participants receive up to 4 doses of mRNA-0184 or placebo over a treatment period

up to 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-0184
• Placebo

Trial Overview The trial is testing mRNA-0184 against a placebo in people with chronic heart failure. It aims to find out how safe it is and how well participants tolerate different doses of this new treatment when given once or multiple times.

How Is the Trial Designed?

Group I: SAD Stage: mRNA-0184 Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-0184.

Group II: MAD Stage: mRNA-0184 Experimental Treatment 1 Intervention

Participants will receive up to 4 doses of mRNA-0184 administered over a treatment period of up to 16 weeks.

Group III: MAD Stage: Placebo Placebo Group 1 Intervention

Participants will receive placebo matching to mRNA-0184 administered over a treatment period of up to 16 weeks.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05659264

NCT05659264 | A Study to Evaluate the Safety of mRNA- ... A Study to Evaluate the Safety of mRNA-0184 in Participants With Heart Failure. ClinicalTrials.gov ID NCT05659264. Sponsor ModernaTX ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11283281/

Translational pharmacokinetic/pharmacodynamic model for ... Translational pharmacokinetic/pharmacodynamic model for mRNA‐0184, an investigational therapeutic for the treatment of heart failure. Neeraj Kaushal. Neeraj ...

3. isrctn.com isrctn.com/ISRCTN79552451

Phase I study to evaluate the safety of mRNA-0184 in ... The study drug is intended to increase the body's ability to make a protein similar to a naturally occurring hormone called relaxin. Researchers believe that ...

4. s29.q4cdn.com s29.q4cdn.com/435878511/files/doc_downloads/program_detail/2023/09/Relaxin-09-13-23.pdf

Relaxin (mRNA-0184) - Moderna Presentation mRNA-0184 encodes Relaxin protein attached to VLK, which extends the half-life of the protein – this longer half-.

5. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-safety-of-mrna-0184-in-participants-with-heart-failure

A Study to Evaluate the Safety of mRNA-0184 in Participants ... The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses at escalating dose levels of ...

6. trials.modernatx.com trials.modernatx.com/study/?id=mRNA-0184-P101

A Study to Evaluate the Safety of mRNA-0184 in ... A Study to Evaluate the Safety of mRNA-0184 in Participants with Heart Failure. This study is: Study Complete. Moderna TX ID. mRNA-0184-P101.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05659264/a-study-to-evaluate-the-safety-of-mrna-0184-in-participants-with-heart-failure

A Study to Evaluate the Safety of mRNA-0184 in ... The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses at escalating dose levels of mRNA-0184.