A Study of LY3981314 in Participants With Autoimmune Hepatitis

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

Fase 1

Rango de edad

18 años - 70 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

12 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (2)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

2 centros

Equipo y fechas

Patrocinador principal

Eli Lilly and Company

Inicio del estudio

2026-12 Estimado

Finalización primaria

2028-06 Estimado

Finalización del estudio

2028-06 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio