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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06916078
The ClinicalTrials.gov registry entry for NCT06916078 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.