Olomorasib for Liver Failure

No longer recruiting at 3 trial locations

Overseen By Eric Lawitz

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Prescription medications

Disqualifiers: Metabolic, Gastrointestinal, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called olomorasib, a potential new drug, to understand its movement and elimination in individuals with varying liver function levels. Participants will include those with mild, moderate, and severe liver issues, as well as those with normal liver function, to observe the drug's behavior across these groups. The study also evaluates the treatment's safety and tolerability. It suits individuals diagnosed with cirrhosis (chronic liver damage) from liver disease, confirmed by medical tests, who can commit to a 6-week study period. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or over-the-counter medications 14 days before starting the trial and throughout the study, unless the investigator approves otherwise.

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

Research shows that olomorasib is being tested for safety, particularly in individuals with varying liver health. As this is an early study, the primary goal is to understand how the drug moves through and is processed by the body. This helps researchers determine if olomorasib is easily tolerated.

Currently, limited safety information exists because the treatment is new. Early trials like this one typically assess immediate side effects and how the body handles the drug. If olomorasib had been approved for another use, it might indicate some safety, but that is not the case here.

Participants will help identify any adverse reactions and their frequency. This early research is a crucial step before more people can safely use the treatment in the future. ^{1 2 3 4 5}

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

Olomorasib is unique because it offers a new approach to treating liver failure by potentially targeting pathways not addressed by current therapies like liver transplantation or medications that manage symptoms. Unlike traditional treatments, Olomorasib is administered orally, which could simplify the treatment process and improve patient adherence. Researchers are excited about its potential to provide a more targeted and less invasive option for patients with varying degrees of hepatic impairment, from mild to severe, while maintaining effectiveness across these different conditions.

What evidence suggests that olomorasib might be an effective treatment for liver failure?

Research has shown that olomorasib, a new drug, could be beneficial for liver conditions by targeting a specific protein involved in liver disease. While direct information on its effects on liver failure is limited, studies have found potential benefits in other conditions, such as certain cancers. In these cases, olomorasib reduced tumor activity when combined with another drug. This trial will evaluate olomorasib in participants with varying degrees of hepatic impairment, including mild, moderate, and severe, as well as those with normal hepatic function. Early results suggest that olomorasib might improve liver function by altering its processing in the body, potentially leading to better liver health. ^{1 2 5 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This study is for adults with varying degrees of liver function, from healthy to severe impairment. Participants will be compared based on their liver health status. Specific details about inclusion and exclusion criteria are not provided.

Inclusion Criteria

My BMI is between 18.0 and 40.0.

I cannot become pregnant or get someone pregnant.

I can stay at the research unit for 5-6 nights and answer a follow-up call.

Exclusion Criteria

I am currently breastfeeding or able to become pregnant.

Abnormal laboratory values determined to be clinically significant by the Investigator (or designee)

Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination

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 Olomorasib to assess pharmacokinetics and safety

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetic outcomes postdose

96 hours

Multiple assessments over 4 days

What Are the Treatments Tested in This Trial?

Interventions

• Olomorasib

Trial Overview

The trial is testing Olomorasib's absorption and clearance in the body among participants with different levels of liver health over a period that could last up to six weeks, including initial screening.

How Is the Trial Designed?

Group I: Olomorasib (Severe Hepatic Impairment) Experimental Treatment 1 Intervention

Olomorasib administered orally.

Group II: Olomorasib (Normal Hepatic Function) Experimental Treatment 1 Intervention

Olomorasib administered orally.

Group III: Olomorasib (Moderate Hepatic Impairment) Experimental Treatment 1 Intervention

Olomorasib administered orally.

Group IV: Olomorasib (Mild Hepatic Impairment) Experimental Treatment 1 Intervention

Olomorasib administered orally.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.

tipranks.com

tipranks.com/news/company-announcements/eli-lillys-olomorasib-study-a-step-forward-in-hepatic-impairment-treatment

Eli Lilly's Olomorasib Study: A Step Forward in Hepatic ...

The primary aim was to evaluate how the drug olomorasib enters the bloodstream and is processed by the body in individuals with varying degrees ...

2.

onclive.com

onclive.com/view/olomorasib-with-pembrolizumab-generates-antitumor-activity-in-kras-g12c-mutant-nsclc

Olomorasib Plus Pembrolizumab Generates Antitumor ...

All grade 3 ALT/AST resolved to grade 1 or baseline after a median of 6 days following dose modification and/or corticosteroids. No grade 2 or ...

3.

withpower.com

withpower.com/trial/olomorasib-for-liver-failure-6fd4c

Olomorasib for Liver Failure · Info for Participants

The main purpose of this study is to assess how olomorasib gets into the blood stream and how long it takes the body to remove it when administered to ...

4.

oncodaily.com

oncodaily.com/dialogues/191628

ASCO24 Updates: Timothy Burns on Olomorasib and ...

Dr. Timothy Burns, shared insights on 'Efficacy and safety of olomorasib (LY3537982), a second-generation KRAS G12C inhibitor (G12Ci), in combination with ...

5.

delta.larvol.com

delta.larvol.com/Products/?ProductId=65d97bf4-8b77-442d-af72-27d99b9c59ac

olomorasib (LY3537982) / Eli Lilly

Delicious. September 23, 2025. A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants ... Trial completion • Hepatitis ...

6.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/34399104/eli-lillys-olomorasib-study-a-closer-look-at-hepatic-impairment-research/

Eli Lilly's Olomorasib Study: A Closer Look at Hepatic ...

' The study aims to evaluate how the drug olomorasib is absorbed and eliminated in the body among individuals with varying degrees of liver ...

7.

app.trialscreen.org

app.trialscreen.org/trials/phase-1-olomorasib-ly3537982-participants-hepatic-impairment-healthy-trial-nct06719128

A Phase 1 study of Olomorasib in hepatic impairment

The study results may help develop better treatment options for people with liver impairment in the future. Risks: As with any investigational drug, there may ...