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LY3981314 for Autoimmune Hepatitis

Not yet recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to assess if a single dose of LY3981314 is safe in participants with autoimmune hepatitis. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body

The study will last about 30 weeks.

Who Is on the Research Team?

C1

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Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for people diagnosed with autoimmune hepatitis. Participants should not have other types of hepatitis, like Hepatitis B, or any conditions that could interfere with the study.

Inclusion Criteria

Have alanine aminotransferase (ALT) greater than 1.5x upper limit of normal (ULN) to less than 5x ULN
Have elevated soluble FAS (sFAS) based on Sponsor predetermined threshold
I have been on the same dose of immunosuppressive medication for AIH for at least 8 weeks.
See 2 more

Exclusion Criteria

Have a controlled attenuation parameter (CAP) score >300 dB/m as measured by transient elastography
Have any medical condition increasing risk of complications related to liver biopsy such as known coagulopathy, inherited disorders of hemostasis, sickle cell disease, amyloidosis
I have or had a chronic liver disease other than autoimmune hepatitis.
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What Are the Treatments Tested in This Trial?

Interventions

  • LY3981314

Trial Overview

The study is testing a single dose of an experimental drug called LY3981314 to see if it is safe and how the body reacts to it in people with autoimmune hepatitis. The study lasts about 30 weeks.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: LY3981314Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

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