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CompletedNCT06719128Updated Sep 22, 2025

A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants

A Phase 1 interventional study of Olomorasib in Hepatic Insufficiency and Healthy, sponsored by Eli Lilly and Company. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Aug 2025, 1 year 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatic Insufficiency
  • Healthy

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Keywords

  • Olomorasib
  • Hepatic Impairment
03

In context

Hepatic Insufficiency

325 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.

This study's enrollment of 46 is above the median of 36 across 220 interventional studies indexed under Hepatic Insufficiency.

Browse Hepatic Insufficiency studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Olomorasib (Mild Hepatic Impairment)

    Olomorasib administered orally.

    Drug: Olomorasib

  • Experimental
    Olomorasib (Moderate Hepatic Impairment)

    Olomorasib administered orally.

    Drug: Olomorasib

  • Experimental
    Olomorasib (Severe Hepatic Impairment)

    Olomorasib administered orally.

    Drug: Olomorasib

  • Experimental
    Olomorasib (Normal Hepatic Function)

    Olomorasib administered orally.

    Drug: Olomorasib

Interventions

  • DrugOlomorasib

    Administered orally.

    Also known as: LY3537982

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib

    PK: Cmax of Olomorasib

    Time frame: Predose on Day 1 up to 96 hours postdose

  2. PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib

    PK: AUC0-inf of Olomorasib

    Time frame: Predose on Day 1 up to 96 hours postdose

07

Study locations

4 sites
  • Orange County Research Center
    Lake Forest, California 92630, United States
  • Clinical Pharmacology of Miami
    Miami, Florida 33014, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • American Research Corporation at Texas Liver Institute
    San Antonio, Texas 78215, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06719128
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Dec 5, 2024
Start date
Dec 6, 2024
Primary completion
Aug 25, 2025
Completion
Aug 25, 2025
Last update
Sep 22, 2025

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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