Olomorasib for Liver Failure
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.12345Why 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.12567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of Olomorasib to assess pharmacokinetics and safety
Follow-up
Participants are monitored for safety and pharmacokinetic outcomes postdose
What Are the Treatments Tested in This Trial?
Interventions
- Olomorasib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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