Olomorasib for Liver Failure

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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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 participants with mild, moderate and severe impaired liver function compared to participants with normal liver function. The safety and tolerability of olomorasib will also be evaluated. The study may last up to 6 weeks for each participant including the screening period.

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.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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