← Back to Search

Other

Osivelotor for Liver Disease

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to investigate how Osivelotor is processed in individuals with liver dysfunction. They are looking for participants with stable mild to moderate liver dysfunction and no other conditions that could affect how the medication works

Who is the study for?
This study is for individuals with stable liver disease of mild or moderate severity, who have a BMI between 16 to 40 kg/m2 and weigh over 50 kg. They should not have had significant changes in their condition within the last month and must be on stable medications for any other health issues.
What is being tested?
The trial is testing how Osivelotor, a medication taken by mouth, is processed by people with impaired liver function. Participants will take one dose before breakfast on the first day and undergo blood tests, physical exams, and other assessments over a maximum of 112 days with five clinic visits.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored through physical exams and tests to ensure Osivelotor's safety. Side effects could relate to how the drug affects liver processing.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have liver cancer, kidney issues related to liver disease, or a short expected lifespan.
Select...
I have liver problems confirmed by tests or a doctor's exam.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Participants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.
Group II: Group 1Experimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,661 Previous Clinical Trials
17,877,980 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,919,130 Total Patients Enrolled
~7 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top