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NCT06916078 · ClinicalTrials.gov registry record · Phase 1
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
A Phase 1 study of Healthy and Liver Dysfunction, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 4
- Study locations
NCT06916078: Recruiting Phase 1 study of Healthy and Liver Dysfunction, sponsored by Eli Lilly and Company.
NCT06916078 is a Phase 1 study of Healthy and Liver Dysfunction that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 33 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06916078, a Phase 1 study of Healthy and Liver Dysfunction, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
PK: AUC of Lepodisiran
Conditions Studied
Interventions
- DRUG Lepodisiran
Study Locations (4)
Florida
- Clinical Pharmacology of Miami - Miami
- Orlando Clinical Research Center - Orlando
Texas
- American Research Corporation at Texas Liver Institute - San Antonio
Other
- CRU Early Phase Unit - Kistarcsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2025-04-23 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT06916078 shows while recruiting
NCT06916078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Lepodisiran is the first listed.
NCT06916078 reports a single indexed study location in Florida, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT06916078 about?
NCT06916078 is a clinical study titled "A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function". 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 w...
What is the current status of trial NCT06916078?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2025-04-23. Estimated completion is 2026-06.
What conditions does trial NCT06916078 study?
This clinical trial studies the following conditions: Healthy, Liver Dysfunction.
What interventions are being tested in trial NCT06916078?
The interventions under investigation include: Lepodisiran (DRUG).
Who is sponsoring clinical trial NCT06916078?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06916078 being conducted?
This trial has 4 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06916078's enrollment target sits among peer trials
33 641st of 1090 higher than 445 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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