VIR-2218 + VIR-3434 for Liver Cirrhosis

Recruiting at3 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Vir Biotechnology, Inc.

Must not be taking: Prescription medications

Disqualifiers: Unstable cardiac, HIV, HBV, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing new drugs VIR-2218 and VIR-3434, either alone or together, in people with liver damage. The goal is to see how these drugs move through the body and if they are safe for patients with liver problems.

Will I have to stop taking my current medications?

If you are a healthy participant, you must stop taking any prescription or over-the-counter medications (except vitamins and hormonal contraceptives) 30 days before the study. If you have liver impairment, you need to be on a stable dose and regimen of your current medications.

Research Team

Eligibility Criteria

This trial is for adults aged 18-70 with liver cirrhosis or impairment, stable health, and a BMI of 18.5-40 kg/m2. They must have a CPT score indicating mild to severe hepatic impairment but can't be on certain medications, have unstable heart conditions, active infections like HIV/HBV/HCV/HDV/HEV (with some exceptions), recent variceal bleeding, or be listed for liver transplantation.

Inclusion Criteria

Healthy matched participants must, in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations

My liver is not working well, but I am healthy enough for the study according to my doctor.

CPT score of 5 to 6 for mild HI at screening

Exclusion Criteria

I am currently listed for or have had a liver transplant.

Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's assessment)

I have HIV, hepatitis A, B, C, D, or E but my viral load is undetectable if positive for HCV or HDV.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434

1 day

Follow-up

Participants are monitored for safety and pharmacokinetic exposure after treatment

4 weeks

Treatment Details

Interventions

• VIR-2218 (Antisense Oligonucleotide)
• VIR-3434 (Antisense Oligonucleotide)

Trial Overview The study tests the effects of single doses of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC alone or in combination on people with different levels of liver function as classified by the Child-Pugh-Turcotte score. It aims to understand how these drugs are processed by the body and their safety profile in those with hepatic issues.

Participant Groups

Group I: Cohort 9: CPT-C (severe HI) and matched healthy participants Experimental Treatment 2 Interventions

This arm is optional based on Cohort 8. All participants in Cohort 9 will be receiving VIR-3434 and VIR-2218 combination therapy.

Group II: Cohort 8: CPT-B (moderate HI) and matched healthy participants Experimental Treatment 2 Interventions

All participants in Cohort 8 will be receiving VIR-3434 and VIR-2218 combination therapy.

Group III: Cohort 7: CPT-A (mild HI) and matched healthy participants Experimental Treatment 2 Interventions

All participants in Cohort 7 will be receiving VIR-3434 and VIR-2218 combination therapy.

Group IV: Cohort 6: CPT-C (severe HI) participants and matched healthy participants Experimental Treatment 1 Intervention

This arm is optional based on Cohort 5. All participants in Cohort 6 will be receiving VIR-3434 monotherapy.

Group V: Cohort 5: CPT-B (moderate HI) participants and matched healthy participants Experimental Treatment 1 Intervention

All participants in Cohort 5 will be receiving VIR-3434 monotherapy.

Group VI: Cohort 4: CPT-A (mild HI) participants and matched healthy participants Experimental Treatment 1 Intervention

All participants in Cohort 4 will be receiving VIR-3434 monotherapy.

Group VII: Cohort 3: CPT-A (mild HI) participants and matched healthy participants Experimental Treatment 1 Intervention

This cohort is optional. All participants in Cohort 3 will be receiving VIR-2218 monotherapy.

Group VIII: Cohort 2: CPT-C (severe HI) participants and matched healthy participants Experimental Treatment 1 Intervention

This arm is optional based on Cohort 1. All participants in Cohort 2 will be receiving VIR-2218 monotherapy.

Group IX: Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated first Experimental Treatment 1 Intervention

All participants in Cohort 1 will be receiving VIR-2218 monotherapy.

Who Is Running the Clinical Trial?

Vir Biotechnology, Inc.

Lead Sponsor

Trials

30

Recruited

13,300+