What side effects are associated with this type of intervention?

Common treatments for liver impairment include medications like tolvaptan, which is used to correct hyponatremia and improve cognitive function, quality of life, and brain edema in cirrhosis. Side effects of tolvaptan are generally well-tolerated but can include thirst, dry mouth, and increased urination. Other treatments, such as feprazone and mirtazapine, have been associated with hepatic injury and steatosis, respectively, leading to symptoms like jaundice and lethargy. For treatments similar to Belzutifan, which targets HIF-2α, specific side effects are not detailed, but monitoring for hepatic function and potential drug-induced liver injury is crucial.

What prior FDA approvals exist?

FDA-approved treatments for liver impairment often focus on managing underlying conditions such as hepatitis, cirrhosis, and hepatocellular carcinoma. For instance, sorafenib and lenvatinib are approved for advanced hepatocellular carcinoma and work by inhibiting multiple kinases involved in tumor growth and angiogenesis. While Belzutifan targets HIF-2α, a specific pathway not commonly addressed by other liver treatments, it represents a novel approach in managing conditions associated with hypoxia and tumor growth. Broader treatments for liver impairment include antiviral therapies for hepatitis C, such as sofosbuvir and simeprevir, which have significantly improved outcomes for patients with viral-induced liver damage.

What other types of research exist?

Promising alternatives to Belzutifan for liver impairment patients include givosiran, which has shown efficacy and safety in reducing attack frequency and improving quality of life in acute hepatic porphyria patients, and Sn-protoporphyrin, which has demonstrated effectiveness in reducing serum bilirubin concentrations in primary biliary cirrhosis and idiopathic haemochromatosis. These treatments offer potential benefits for managing liver-related conditions in 2024.

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HIF-2alpha Inhibitor

Belzutifan for Liver Impairment

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to dose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96, and 120 hours postdose

Awards & highlights

Study Summary

This trial will compare how well the body processes a new drug, belzutifan, in people with moderate liver impairment versus healthy people. It will also look at how safe and tolerable the drug is in people with moderate liver impairment.

Who is the study for?

This trial is for adults with stable moderate liver impairment and healthy individuals, both having a BMI of 18.0-40.0 kg/m². Women must be incapable of childbearing, while men should either practice abstinence or use contraception if sexually active with women who can bear children. Participants shouldn't have significant medical conditions, recent surgeries, drug abuse history, heavy nicotine/alcohol use, or certain vaccinations close to the study period.Check my eligibility

What is being tested?

The trial tests how a single dose of Belzutifan (80 mg) behaves in the bloodstream of people with moderate liver problems compared to healthy individuals. It also assesses the safety and tolerability of this medication in those with liver issues.See study design

What are the potential side effects?

While specific side effects are not listed here, generally such trials monitor for any adverse reactions including but not limited to gastrointestinal symptoms, allergic reactions, changes in blood pressure or heart rate, headaches or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to dose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96, and 120 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to dose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96, and 120 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to dose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96, and 120 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apparent terminal half-life (t½) of plasma concentration

Area under the plasma concentration time curve from hour 0 to 24 (AUC0-24)

Area under the plasma concentration time curve from hour 0 to infinity (AUC0-inf)

+2 more

Secondary outcome measures

Number of participants who discontinued from the study due to an AE

Number of participants who experienced an adverse event

Trial Design

2Treatment groups

Experimental Treatment

Group I: Belzutifan in participants with normal hepatic functionExperimental Treatment1 Intervention

Participants with normal hepatic function will receive a single oral 80 mg dose of belzutifan.

Group II: Belzutifan in participants with moderate hepatic impairmentExperimental Treatment1 Intervention

Participants with moderate hepatic impairment will receive a single oral 80 mg dose of belzutifan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belzutifan

2018

Completed Phase 1

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver impairment, such as Belzutifan, work by targeting specific molecular pathways to manage disease progression and symptoms. Belzutifan inhibits hypoxia-inducible factor-2 alpha (HIF-2α), reducing abnormal cell growth and angiogenesis, which are critical in liver diseases. Other treatments like ursodeoxycholic acid improve bile flow and reduce inflammation, while systemic therapies such as atezolizumab plus bevacizumab target cancer cells in liver conditions like hepatocellular carcinoma. These mechanisms are crucial for liver impairment patients as they help in selecting therapies that can effectively manage the disease, slow its progression, and enhance liver function.

Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.Regorafenib could cause sinusoidal obstruction syndrome.Pharmacokinetics and safety of galantamine in subjects with hepatic impairment and healthy volunteers.