A Study of LY3981314 in Participants With Autoimmune Hepatitis

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 70 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

12 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Have a confirmed diagnosis of autoimmune hepatitis (AIH) for greater than or equal to (≥) 6 months according to American Association for the Study of Liver Diseases diagnostic criteria (Appendix 8, Section 10.8)
• 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
• Be on a stable immunosuppressive medication regimen for AIH with no dose changes or weaning of treatment for ≥8 weeks prior to screening, and no anticipated medication adjustments until after the post-treatment liver biopsy at Day 29. The following medications are permitted for the management of AIH:

• Azathioprine
• 6-Mercaptopurine
• Inhibitors of inosine monophosphate dehydrogenase (mycophenolate mofetil, mycophenolate sodium, mycophenolic acid)
• Tacrolimus
• Cyclosporine
• Corticosteroids at a dose equivalent to less than or equal to (≤) 10 mg of prednisone per day

Exclusion Criteria:

• Have clinical, laboratory, histological, or imaging evidence of cirrhosis
• Have a controlled attenuation parameter (CAP) score \>300 decibel-milliwatt (dB/m) as measured by transient elastography
• Have clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities

• international normalized ratio \>1.3
• history of esophageal varices, ascites or hepatic encephalopathy
• Have or had other forms of chronic liver disease per Medical History:

• alcoholic liver disease
• hepatitis B
• hepatitis C
• history of primary biliary cholangitis or primary sclerosing cholangitis
• history of celiac disease, or other autoimmune disorders including immune-checkpoint related hepatitis associated with elevated aminotransferases
• uncontrolled thyroid disease
• current drug-induced liver disease based on typical exposure and history
• metabolic dysfunction associated steatohepatitis, Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, or cystic fibrosis-related liver disease
• suspected or proven liver cancer
• any other physician confirmed liver disease other than AIH
• Have any medical condition that, in the opinion of the investigator, may increase the risk of complications related to liver biopsy (for example, a known coagulopathy, inherited disorders of hemostasis, sickle cell disease, amyloidosis)
• Have any of the following laboratory abnormalities at screening:

• Platelet count \<150,000/cubic millimeter (mm³)
• Hemoglobin

• \<10 grams per deciliter (g/dL) for individuals assigned female at birth (AFAB)
• \<11 g/dL for individuals assigned male at birth (AMAB)
• Absolute neutrophil count \<1000/mm³
• Transferrin saturation \>50 percentage (%) (except when it has been demonstrated that a diagnosis of hemochromatosis has been excluded by genetic testing or when a previous liver biopsy has demonstrated no evidence of iron overload.)
• Total bilirubin \> ULN unless known Gilbert's syndrome per Medical History.

• Gilbert's syndrome participant must have normal direct bilirubin; if diagnosis of Gilbert's cannot be confirmed by medical records, participant may not participate in the study
• Have renal impairment measured as estimated glomerular filtration rate\<60 milliliters per minute (mL/min)/1.73 square meter (m²), calculated using the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (2021 version), as determined by the local laboratory during screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

Eli Lilly and Company

Study start

2026-12 Estimated

Primary completion

2028-06 Estimated

Study completion

2028-06 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts