Hepatic InsufficiencyPhase 1NCT06719128
A Study of Olomorasib (LY3537982) in Participants With Hepatic Impairment and Healthy Participants
A Phase 1 study testing Olomorasib in people with Hepatic Insufficiency and Healthy, run by Eli Lilly and Company at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency, Healthy
- What is being tested?
- Olomorasib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Dec 2024to 25 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Metabolic disease
- Gastrointestinal disease
- Hematological disease
- Neurological disease
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Orange County Research Center
Lake Forest, California, 92630
Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: An Open-Label, Nonrandomized, Single-Dose, Safety and Pharmacokinetic Study of LY3537982 in Participants With Hepatic Impairment and Healthy 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 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.
- Conditions
- Hepatic Insufficiency, Healthy
- Being tested
- Olomorasib
- Keywords
- Olomorasib, Hepatic Impairment
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlomorasibDrug
Also called LY3537982
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Olomorasib (Mild Hepatic Impairment) | Experimental | Olomorasib administered orally. Receives: Drug: Olomorasib |
| Olomorasib (Moderate Hepatic Impairment) | Experimental | Olomorasib administered orally. Receives: Drug: Olomorasib |
| Olomorasib (Severe Hepatic Impairment) | Experimental | Olomorasib administered orally. Receives: Drug: Olomorasib |
| Olomorasib (Normal Hepatic Function) | Experimental | Olomorasib administered orally. Receives: Drug: Olomorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib
PK: Cmax of Olomorasib
Measured: Predose on Day 1 up to 96 hours postdose
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib
PK: AUC0-inf of Olomorasib
Measured: Predose on Day 1 up to 96 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start6 Dec 2024
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719128
- Sponsor's protocol ID
- 18677
- Other IDs
- J3M-OX-JZQF
- Status last verified
- Sep 2025
- First submitted
- 2 Dec 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Nonrandomized, Single-Dose, Safety and Pharmacokinetic Study of LY3537982 in Participants With Hepatic Impairment and Healthy Participants
- ClinicalTrials.gov ID
- NCT06719128
- Acronym / sponsor ID
- 18677
- Conditions
- Hepatic Insufficiency, Healthy
- Keywords
- Olomorasib, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Olomorasib (Mild Hepatic Impairment) | Experimental | Drug: OlomorasibOlomorasib administered orally. |
| Olomorasib (Moderate Hepatic Impairment) | Experimental | Drug: OlomorasibOlomorasib administered orally. |
| Olomorasib (Severe Hepatic Impairment) | Experimental | Drug: OlomorasibOlomorasib administered orally. |
| Olomorasib (Normal Hepatic Function) | Experimental | Drug: OlomorasibOlomorasib administered orally. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlomorasibAlso: LY3537982Administered orally. | Drug | Olomorasib (Mild Hepatic Impairment), Olomorasib (Moderate Hepatic Impairment), Olomorasib (Normal Hepatic Function), Olomorasib (Severe Hepatic Impairment) |
Primary outcome
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib
Time frame: Predose on Day 1 up to 96 hours postdose
PK: Cmax of Olomorasib
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-inf) of Olomorasib
Time frame: Predose on Day 1 up to 96 hours postdose
PK: AUC0-inf of Olomorasib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Hepatic Insufficiency
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olomorasib in people with Hepatic Insufficiency and Healthy, run by Eli Lilly and Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of Olomorasib (time frame: Predose on Day 1 up to 96 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.