MK-8527 for Liver Disease

Recruiting at 1 trial location

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Cancer, HIV, Major surgery, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MK-8527, an experimental drug, to observe its behavior in the body over time. Researchers compare the effects of MK-8527 on healthy individuals and those with mild to moderate liver problems. Participants will receive a single dose of the treatment. Individuals diagnosed with stable chronic liver issues might be a good fit. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that MK-8527 is likely to be safe for humans?

Research has shown that MK-8527 is generally well tolerated, with most people not experiencing severe side effects. In previous studies, no serious side effects were reported. Testing in individuals without liver disease found MK-8527 to be safe. The drug's behavior in the body is predictable, with higher doses leading to expected increases in its presence. Another study found MK-8527 to be a safe and effective treatment for fatty liver disease in people with HIV, suggesting potential safety for other liver conditions. Overall, evidence suggests that MK-8527 is likely well tolerated in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MK-8527 because it offers a potentially new way to tackle liver disease. Unlike traditional treatments that often focus on managing symptoms or slowing disease progression, MK-8527 may work through a novel mechanism, directly targeting the underlying causes of liver impairment. This direct approach could result in more effective treatment outcomes and improve liver function more swiftly than existing options. Moreover, MK-8527 is being tested across various levels of liver impairment, which could help it become a versatile treatment option for a wide range of patients.

What evidence suggests that MK-8527 might be an effective treatment for liver disease?

Research shows that MK-8527 is under investigation as a treatment for HIV-1. It blocks an enzyme necessary for the virus to reproduce. Studies suggest that MK-8527 might reduce the viral load in the body. Although detailed information about its effects on liver disease in humans is lacking, its enzyme-targeting mechanism hints at potential benefits for conditions involving viral replication. This trial will evaluate MK-8527 in participants with varying degrees of hepatic impairment and in healthy participants. Early research examines its safety and pharmacokinetics. ^{1 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate liver impairment and healthy individuals. It aims to understand how a drug, MK-8527, behaves in the body over time. Participants must be non-smokers and not have any other significant medical conditions.

Inclusion Criteria

I have been diagnosed with long-term liver disease with cirrhosis.

I have mild or moderate liver problems but am otherwise healthy.

I am healthy with no significant medical issues.

Exclusion Criteria

I have mild or moderate liver impairment, no significant health or mental issues, and am not positive for Hepatitis B or C.

All participants must not have positive results for human immunodeficiency virus (HIV)

I haven't had major surgery or lost a lot of blood in the last 56 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of MK-8527 on Day 1

1 day

1 visit (in-person)

Pharmacokinetic Monitoring

Plasma and blood samples are collected at pre-specified timepoints to determine pharmacokinetic parameters of MK-8527

4 weeks

Multiple visits (in-person) for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-8527

Trial Overview The study is testing MK-8527 by observing its pharmacokinetics—how it's absorbed, distributed, metabolized, and excreted in those with varying degrees of liver health compared to healthy volunteers.

How Is the Trial Designed?

Group I: Moderate Hepatic Impairment (Group 2) Experimental Treatment 1 Intervention

All participants will receive a single dose of MK-8527 on Day 1.

Group II: Mild Hepatic Impairment (Group 1) Experimental Treatment 1 Intervention

All participants will receive a single dose of MK-8527 on Day 1.

Group III: Healthy (Group 3) Experimental Treatment 1 Intervention

All participants will receive a single dose of MK-8527 on Day 1.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11514626/

State of the ART (antiretroviral therapy): Long-acting HIV-1 ... These inhibitors include islatravir (ISL, EFdA, or MK-8591) and MK-8527. All of these classes - NNRTIs, NRTIs, and NRTTIs - target HIV-1 RT. This viral enzyme ...

2. aidsmap.com aidsmap.com/node/38849/preview

Contents Researchers from the SLIM LIVER trial found that semaglutide taken for six months reduced liver fat by 31% and that semaglutide was generally ...

3. merck.com merck.com/news/merck-to-present-new-data-from-hiv-treatment-and-prevention-pipeline-at-european-aids-conference-2025/

Merck to Present New Data from HIV Treatment and ... A poster presentation of MK-8527 Phase 1 safety and pharmacokinetics data in adults with moderate or severe renal impairment ... Outcomes ...

4. synapse.patsnap.com synapse.patsnap.com/drug/97ec4fb84ec54f01917cf20f6d71c22e

MK-8527 - Drug Targets, Indications, Patents The primary efficacy endpoint was the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 (non-inferiority margin 4%). In this trial, 513 adults ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07071623

NCT07071623 | A Study of MK-8527 to Prevent Human ... The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis ( ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0166870

Hepatic Impairment (HI) (DBCOND0166870) Associated Data ; NCT07025551. A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015). MK-8527 ; NCT01271387.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12435975/

Safety and Pharmacokinetics of MK‐8527 in Adults Without ... MK‐8527 was generally well tolerated with no serious adverse events. Plasma exposure of MK‐8527 increased approximately dose‐proportionally, and ...

8. globalhealthmedicine.com globalhealthmedicine.com/site/download-doc-pdf.html?docid=386

State of the ART (antiretroviral therapy): Long-acting HIV-1 ... Safety and pharmacokinetic study of oral MK-8527 QM in participants at low-risk for HIV-. 1 infection (MK-8527-007). https://classic.clinicaltrials. gov/show/ ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07063238

A Clinical Study of MK-8527 in Healthy Adult Participants ... Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...