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Compensation: Varies

Number of Visits: 1

Duration: 1 day

Etavopivat for Liver Disease

No longer recruiting at 1 trial location

Overseen ByNovo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: UGT2B7 inhibitors, CYP3A4 inducers

Disqualifiers: Pregnancy, Diabetes, Hepatitis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called etavopivat to evaluate its effects in people with liver problems. The goal is to compare the drug's effects in individuals with liver impairments to those with normal liver function. Participants will take one dose of etavopivat and undergo monitoring for about a week. The trial seeks individuals with chronic liver issues that have been stable for over six months or generally healthy individuals. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new drug.

Will I have to stop taking my current medications?

Participants with hepatic impairment must be on a stable dose of their current medications for at least 14 days before the study. However, all participants must avoid certain medications that affect liver enzymes for a specified period before and during the study.

Is there any evidence suggesting that etavopivat is likely to be safe for humans?

Research has shown that etavopivat has been tested for safety in people. This drug is being developed to activate a specific enzyme in red blood cells. In earlier studies, most participants tolerated it well. Some mild to moderate side effects, such as headaches and nausea, were reported, but serious side effects were rare.

As this is an early-phase trial, researchers are still learning about the drug's safety. While initial results are promising, the drug remains under study. Participants in this trial will help provide more information on how well etavopivat is tolerated, particularly in individuals with liver conditions.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about etavopivat for liver disease because it offers a new approach to addressing hepatic impairment. Unlike standard treatments, which often focus on managing symptoms or slowing progression, etavopivat works by enhancing oxygen delivery and improving blood flow. This mechanism could potentially improve liver function more effectively. Additionally, etavopivat is administered orally, making it a convenient option compared to some current treatments that require injections or infusions. This novel approach has the potential to offer a more direct and efficient way to support liver health.

What evidence suggests that this trial's treatment, etavopivat, could be effective for liver disease?

Research has shown that etavopivat holds potential for treating conditions like sickle cell disease (SCD). In studies with SCD patients, the drug was well-tolerated, improved red blood cell health, and increased hemoglobin levels. Although limited information exists on its effects on liver disease, these positive results in blood-related conditions suggest potential benefits. This trial will explore different doses of etavopivat in participants with varying degrees of hepatic impairment and healthy matched controls. The drug improves red blood cell function, which might aid some liver issues. Early findings are promising, but further research is needed to confirm its effectiveness for liver disease.¹ ³ ⁶ ⁷ ⁸

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 adults with a BMI of 18.5-42 kg/m^2 and weight over 40 kg, who have stable liver disease (Child-Pugh class A, B or C) or normal liver function. Participants must not be on prohibited medications, have no severe allergies to the drug being tested, and women should not be pregnant or breastfeeding.

Inclusion Criteria

Body mass index (BMI) between 18.5 and 42.0 kilogram per meter^2 (kg/m^2) at screening

I am either male or female.

My weight is at least 40 kg.

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Exclusion Criteria

Participant unable to refrain from or anticipates the use of any medications or substances prohibited in the study

Known or suspected hypersensitivity to study intervention or related products

Participation in any interventional clinical study within 30 days or 5 times the half-life of the previous investigational medical product (IMP) before screening

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of etavopivat

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, safety, and tolerability after dosing

7-9 days

Daily monitoring (in-person)

What Are the Treatments Tested in This Trial?

Interventions

Etavopivat

Trial Overview The study tests etavopivat in people with different levels of liver health. Each participant will take a single oral dose of etavopivat with water. The effects will then be monitored for about a week to see how it works in those with and without liver issues.

How Is the Trial Designed?

5Treatment groups

Experimental Treatment

Group I: Severe hepatic impairment: Etavopivat dose 1Experimental Treatment1 Intervention