Liver DysfunctionPhase 1NCT06916078
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
A Phase 1 study testing Lepodisiran in people with Liver Dysfunction and Healthy, run by Eli Lilly and Company at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Dysfunction, Healthy
- What is being tested?
- Lepodisiran
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Apr 2025to 13 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 diagnosis and standard-of-care practice
Who cannot join
- Have significant history of, or current, cardiovascular (CV), respiratory, hepatic (hepatic applies to Group 1 only), renal, gastrointestinal, endocrine, hematological, or neurological disorders
- Have severe atopy or a history of clinically significant multiple or severe drug allergies
- Have known allergies to lepodisiran, related compounds, or any components of the formulation
- Have a history of, or current, psychiatric disorders
- Have had any malignancy within the past 5 years
- Have estimated glomerular filtration rate (eGFR) less than 60 milliliters per minute per 1.73 m² (mL/min/1.73 m²) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Have participated, within the last 1 month, in a clinical study involving an investigational product
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Clinical Pharmacology of Miami
Miami, Florida, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, 32809
American Research Corporation at Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: 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
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.
- Conditions
- Liver Dysfunction, Healthy
- Being tested
- Lepodisiran
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LepodisiranDrug
Also called LY3819469
Lepodisiran administered SC
| Study group | Role | What they receive |
|---|---|---|
| Lepodisiran Group 1 | Experimental | Lepodisiran administered subcutaneously (SC) Receives: Drug: Lepodisiran |
| Lepodisiran Group 2 | Experimental | Lepodisiran administered SC Receives: Drug: Lepodisiran |
| Lepodisiran Group 3 | Experimental | Lepodisiran administered SC Receives: Drug: Lepodisiran |
| Lepodisiran Group 4 | Experimental | Lepodisiran administered SC Receives: Drug: Lepodisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran
PK: AUC of Lepodisiran
Measured: Baseline Up to 9 weeks
PK: Maximum Concentration (Cmax) of Lepodisiran
PK: Cmax of Lepodisiran
Measured: Baseline Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start23 Apr 2025
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DysfunctionStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916078
- Sponsor's protocol ID
- 27200
- Other IDs
- J3L-MC-EZEH, 2024-520315-40-00
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06916078
- Acronym / sponsor ID
- 27200
- Conditions
- Liver Dysfunction, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lepodisiran Group 1 | Experimental | Drug: LepodisiranLepodisiran administered subcutaneously (SC) |
| Lepodisiran Group 2 | Experimental | Drug: LepodisiranLepodisiran administered SC |
| Lepodisiran Group 3 | Experimental | Drug: LepodisiranLepodisiran administered SC |
| Lepodisiran Group 4 | Experimental | Drug: LepodisiranLepodisiran administered SC |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- For Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:
Key exclusion criteria (7 listed)
- Have significant history of, or current, cardiovascular (CV), respiratory, hepatic (hepatic applies to Group 1 only), renal, gastrointestinal, endocrine, hematological, or neurological disorders
- Have severe atopy or a history of clinically significant multiple or severe drug allergies
- Have known allergies to lepodisiran, related compounds, or any components of the formulation
- Have a history of, or current, psychiatric disorders
- Have had any malignancy within the past 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LepodisiranAlso: LY3819469Lepodisiran administered SC | Drug | Lepodisiran Group 1, Lepodisiran Group 2, Lepodisiran Group 3, Lepodisiran Group 4 |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran
Time frame: Baseline Up to 9 weeks
PK: AUC of Lepodisiran
PK: Maximum Concentration (Cmax) of Lepodisiran
Time frame: Baseline Up to 9 weeks
PK: Cmax of Lepodisiran
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lepodisiran in people with Liver Dysfunction and Healthy, run by Eli Lilly and Company at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Lepodisiran (time frame: Baseline Up to 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.