Assessing how olomorasib is processed in people with liver impairment and healthy individuals

An Open-Label, Nonrandomized, Single-Dose, Safety and Pharmacokinetic Study of LY3537982 in Participants With Hepatic Impairment and Healthy Participants

This study is testing how a drug called olomorasib is processed in the body of people with liver problems compared to healthy individuals to see if it's safe and how well it works.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eli Lilly and Company (Industry-sponsored)
• Locations: 4 sites (Lake Forest, California and 3 other locations)
• Trial ID: NCT06719128 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics of olomorasib, focusing on how it is absorbed and eliminated in participants with varying degrees of liver impairment compared to healthy individuals. Participants will be categorized based on their liver function, and the study will monitor the safety and tolerability of the drug over a period of up to six weeks. The research aims to provide insights into the drug's behavior in the bloodstream and its potential effects on individuals with hepatic insufficiency.

Who should consider this trial

Good fit: Ideal candidates include males and females with documented hepatic impairment or healthy individuals within a specified BMI range.

Not a fit: Patients with significant liver disease not meeting the study criteria or those who are lactating or of childbearing potential may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of olomorasib's safety and efficacy in patients with liver impairment, leading to better treatment options.

How similar studies have performed: While studies on drug metabolism in hepatic impairment are common, this specific investigation into olomorasib's pharmacokinetics is novel.

Eligibility criteria

Inclusion Criteria:

* Males and females of non-childbearing potential.
* Men or women with a body mass index of 18.0 to 40.0 kilograms per meter squared (kg/m²).
* Able to comply with all study procedures, including the 5- to 6-night stays at the CRU and the follow-up phone call.
* Healthy participants: In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at screening and/or admission as assessed by the investigator (or designee).
* Participants with hepatic impairment: Diagnosis of cirrhosis due to parenchymal liver disease, which is confirmed and documented by at least one of the following: medical history, physical examination, hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy.

Exclusion Criteria:

* Females who are lactating or of childbearing potential.
* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

  1. Metabolic disease
  2. Gastrointestinal disease
  3. Hematological disease
  4. Neurological disease
  5. History or presence of clinically significant cardiovascular disease.
* 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.
* Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
* Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial, unless deemed acceptable by the investigator (or designee) and medical monitor.
* History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.

Where this trial is running

Lake Forest, California and 3 other locations

• Orange County Research Center — Lake Forest, California, United States (Recruiting)
• Clinical Pharmacology of Miami — Miami, Florida, United States (Recruiting)
• Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
• American Research Corporation at Texas Liver Institute — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Conditions Hepatic Insufficiency; Healthy; Olomorasib; Hepatic Impairment