Etavopivat for Heart Rhythm

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: Antacids, Iron, St. John's Wort

Disqualifiers: Pregnancy, Tobacco use, ECG abnormalities, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Etavopivat affects the heart's electrical activity in healthy individuals. The study consists of two parts: the first tests a high dose of Etavopivat, while the second compares different doses and a placebo. It targets individuals who are generally healthy and not using certain medications or tobacco. The trial aims to gather information about the safety and effects of Etavopivat before its use in treating sickle cell disease. Participants will assist researchers in understanding the new medicine's mechanisms. As a Phase 1 trial, this research focuses on how Etavopivat functions in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications, including antacids, iron, and drugs that affect specific enzymes, for 28 days before starting and throughout the study. If you're taking any of these, you may need to stop them.

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

Research has shown that Etavopivat does not cause QT-prolongation, meaning it does not affect the heart's electrical signals. Studies found no impact on heart rate, suggesting the treatment is well-tolerated. This offers reassurance about its safety. However, the trial is in an early phase, just beginning to test safety in humans. While safety data remains limited, earlier studies showed no major heart-related side effects from Etavopivat. Participants can expect careful health monitoring during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike most treatments for heart rhythm issues, which often rely on medications like beta-blockers or calcium channel blockers, Etavopivat works by targeting different mechanisms in the body. Researchers are excited about Etavopivat because it acts on red blood cells to enhance their energy production, potentially improving oxygen delivery throughout the body. This novel approach could lead to more efficient management of heart rhythm conditions, offering hope for faster and possibly more effective relief compared to traditional therapies. Additionally, Etavopivat's unique mechanism may result in fewer side effects, making it a promising alternative for patients who struggle with current treatments.

What evidence suggests that this trial's treatments could be effective for heart rhythm?

Research is examining how Etavopivat affects heart rhythm, particularly the heart's electrical activity. Although limited information exists on its potential for treating sickle cell disease (SCD), this trial primarily focuses on its impact on the heart in healthy individuals. Participants will receive a single dose of Etavopivat, while others will receive a placebo or moxifloxacin in different study arms. Etavopivat is believed to work by affecting certain pathways that could alter heart function. Early results suggest it might have an effect, but further studies are needed to fully understand its potential benefits. Since the current research involves healthy participants, conclusions about its effectiveness for SCD are not yet available. ^{2 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 healthy individuals who can participate in a study to understand the effects of Etavopivat on heart rhythm. Participants will be randomly assigned to receive either Etavopivat or a placebo, and must be available for the duration of the study phases.

Inclusion Criteria

I am either male or female.

I am between 18 and 55 years old.

Body mass index (BMI) between 18.0 and 32.0 kg/m^2 at screening

Exclusion Criteria

The study aims to include a balanced number of men and women.

Current participation in any other interventional clinical study

Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (IMP) before screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A: Treatment

Participants receive a single dose of Etavopivat or placebo to assess safety

10-36 days

1 visit (in-person)

Part B: Treatment

Participants receive four different treatments on four occasions with a 7-day break between each

27-53 days

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Etavopivat

Trial Overview The trial tests how Etavopivat affects heart electrical activity. It has two parts: Part A (safety of high dose) with single-dose treatment, and Part B (comparing different doses and medicines), where participants get four treatments including two doses of Etavopivat, a placebo, and moxifloxacin.

How Is the Trial Designed?

Group I: Part B- Moxifloxacin Experimental Treatment 1 Intervention

Participants will receive a single dose of moxifloxacin.

Group II: Part B- Etavopivat Experimental Treatment 1 Intervention

Participants will receive a single dose of etavopivat.

Group III: Part A- Etavopivat Experimental Treatment 1 Intervention

Participants will receive a single dose of etavopivat.

Group IV: Part B- Placebo Placebo Group 1 Intervention

Participants will receive a single dose of placebo.

Group V: Part A- Placebo Placebo Group 1 Intervention

Participants will receive a single dose of placebo.

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. trial.medpath.com trial.medpath.com/clinical-trial/338d1528ba6fb10c/nct07023029-etavopivat-cardiac-repolarisation-healthy-participants

A Study on the Effect of Etavopivat on Heart Rhythm in Healthy ... The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study ...

2. clinconnect.io clinconnect.io/trials/NCT07023029

A Study on the Effect of Etavopivat on Heart Rhythm in However, in this study, the researchers want to see how Etavopivat affects heart rhythm in healthy volunteers. The trial has two parts: the first part will ...

3. withpower.com withpower.com/trial/phase-1-thalassemia-5-2025-5be70

Etavopivat for Heart Rhythm · Info for Participants The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study comprises two parts ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05725902

Study of the Effect of Etavopivat on Cerebral Hemodynamic ... This study is a pilot, open-label, single-arm study to evaluate the effect of etavopivat on cerebral hemodynamics, as measured by frequency domain near- ...

5. smartpatients.com smartpatients.com/trials/NCT07023029

A Study on the Effect of Etavopivat on Heart Rhythm ... The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study comprises two parts ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9306898/

Safety, Pharmacokinetics, and Pharmacodynamics of ... For the SAD cohorts with high‐quality ECG data, no QT‐prolongation effects of etavopivat were observed. There were no heart rate effects nor ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04987489

NCT04987489 | A Study of Etavopivat in Patients With ... This clinical trial is a Phase 2 study that will evaluate the safety and clinical activity of etavopivat in patients with thalassemia or sickle cell disease ...

8. clinicaltrials.eu clinicaltrials.eu/trial/long-term-safety-study-of-etavopivat-for-adults-adolescents-and-children-with-sickle-cell-disease-or-thalassemia/

Long-term safety study of oral etavopivat tablets in children ... This study assesses the long-term safety and effectiveness of Etavopivat, a tablet-form medication, in treating individuals with blood disorders, ...

9. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/pdf/10.1002/cpdd.1058

4202), an Allosteric Activator of Pyruvate Kinaseâ The safety analysis set included all participants who received ≥1 dose of any study treatment (etavo- pivat or placebo). The PK analysis set included all.