A Phase 1, Multicenter, Sequential-Design, Single-Dose, Open-Label Study of Lepodisiran in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment
Eli Lilly and Company
Summary
The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild, moderate, or severe liver function impairment compared to participants with normal liver function. The study will also evaluate how well lepodisiran is tolerated and what side effects may occur in these participants. The study will last up to approximately 9 weeks, excluding screening.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Have a body weight of 55 kilogram (kg) or more and body mass index within the range 19.0 to 42.0 kilogram per square meter (kg/m²) * Additional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1: * Healthy participants with clinically normal hepatic function * For Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4: * Participants with hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment). Diagnosis of chronic hepatic impairment of greater than 6 months, per physician diagnos…
Interventions
- DrugLepodisiran
Lepodisiran administered SC
Locations (4)
- Clinical Pharmacology of MiamiMiami, Florida
- Orlando Clinical Research CenterOrlando, Florida
- American Research Corporation at Texas Liver InstituteSan Antonio, Texas
- CRU Early Phase UnitKistarcsa