Lipoprotein(a)Phase 1NCT07914738
A Study of Lepodisiran (LY3819469) in Participants With High Lipoprotein(a)
A Phase 1 study testing LY3819469 in people with Lipoprotein(a), run by Eli Lilly and Company.
Trial summary
The main purpose of this study will evaluate how the body takes in lepodisiran (LY3819469) after a single injection under the skin. Researchers will compare how much lepodisiran gets into the body from each injection site. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipoprotein(a)
- What is being tested?
- LY3819469
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be 18 (21 for the Singapore site) to 70 years of age, inclusive, at the time of signing the ICF.
- Are overtly healthy as determined by medical evaluation including medical history, physical examination and other screening procedures.
- Have Lp(a) levels greater than or equal to (≥)75 nanomole per liter (nmol/L) as measured by the central laboratory.
- Have, except for Lp(a) and lipid panel, clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- Have a body mass index within the range of 18.5 to 35.0 kilograms per square meter (kg/m²), inclusive, at the time of screening.
- Are individuals assigned male at birth (AMAB) or assigned female at birth (AFAB).
Who cannot join
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Have had any history of clinically overt cardiovascular disease (CVD).
- Have known allergies to lepodisiran, related compounds, or any components of the formulation.
- Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction.
- Have clinically significant multiple or severe drug allergies.
- Have a history or presence of psychiatric disorders.
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- Have participated, within the last 1 month, in a clinical study involving an investigational product.
- Have previously completed or withdrawn from this study or any other study investigating an Lp(a) small interfering ribonucleic acid (RNA) therapeutic within 1 year prior to screening.
- Have an estimated glomerular filtration rate less than (<)60 milliliter per minute per 1.73 square meters (mL/min/1.73 m²).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
About this study
Official title: A Phase 1, Open-Label, Pharmacokinetic Study of Lepodisiran Administered as a Single Subcutaneous Dose in the Abdomen, Thigh, or Upper Arm in Healthy Participants With High Lipoprotein(a)
The main purpose of this study will evaluate how the body takes in lepodisiran (LY3819469) after a single injection under the skin. Researchers will compare how much lepodisiran gets into the body from each injection site. The study will also look at how safe lepodisiran is and how it affects lipoprotein(a) (Lp(a)), in healthy adults who have high Lp(a) levels. Participants will take part in the study for about 17 weeks.
Participants will be admitted to the clinical research unit on Day -1 and remain confined until discharge on Day 4. The study drug will be administered on Day 1. Participants will return to the clinical research unit for outpatient visits on Days 8, 15, 29, and 57.
- Conditions
- Lipoprotein(a)
- Being tested
- LY3819469
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3819469Drug
Also called Lepodisiran
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3819469 (Upper Arm) | Experimental | Administered subcutaneously (SC) in the upper arm Receives: Drug: LY3819469 |
| LY3819469 (Thigh) | Experimental | Administered SC in the thigh Receives: Drug: LY3819469 |
| LY3819469 (Abdomen) | Experimental | Administered SC in the abdomen Receives: Drug: LY3819469 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3819469
Measured: Day 1 through Day 15
PK: Area Under the Concentration versus Time Curve (AUC) of LY3819469
Measured: Day 1 through Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipoprotein(a)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
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
- NCT07914738
- Sponsor's protocol ID
- 27848
- Other IDs
- J3L-MC-EZEK
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Pharmacokinetic Study of Lepodisiran Administered as a Single Subcutaneous Dose in the Abdomen, Thigh, or Upper Arm in Healthy Participants With High Lipoprotein(a)
- ClinicalTrials.gov ID
- NCT07914738
- Acronym / sponsor ID
- 27848
- Conditions
- Lipoprotein(a)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Nov 2026 (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 will evaluate how the body takes in lepodisiran (LY3819469) after a single injection under the skin. Researchers will compare how much lepodisiran gets into the body from each injection site. The study will also look at how safe lepodisiran is and how it affects lipoprotein(a) (Lp(a)), in healthy adults who have high Lp(a) levels. Participants will take part in the study for about 17 weeks.
Participants will be admitted to the clinical research unit on Day -1 and remain confined until discharge on Day 4. The study drug will be administered on Day 1. Participants will return to the clinical research unit for outpatient visits on Days 8, 15, 29, and 57.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3819469 (Upper Arm) | Experimental | Drug: LY3819469Administered subcutaneously (SC) in the upper arm |
| LY3819469 (Thigh) | Experimental | Drug: LY3819469Administered SC in the thigh |
| LY3819469 (Abdomen) | Experimental | Drug: LY3819469Administered SC in the abdomen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be 18 (21 for the Singapore site) to 70 years of age, inclusive, at the time of signing the ICF.
- Are overtly healthy as determined by medical evaluation including medical history, physical examination and other screening procedures.
- Have Lp(a) levels greater than or equal to (≥)75 nanomole per liter (nmol/L) as measured by the central laboratory.
- Have, except for Lp(a) and lipid panel, clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- Have a body mass index within the range of 18.5 to 35.0 kilograms per square meter (kg/m²), inclusive, at the time of screening.
Key exclusion criteria (9 listed)
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Have had any history of clinically overt cardiovascular disease (CVD).
- Have known allergies to lepodisiran, related compounds, or any components of the formulation.
- Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction.
- Have clinically significant multiple or severe drug allergies.
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 |
|---|---|---|
| LY3819469Also: LepodisiranAdministered SC | Drug | LY3819469 (Abdomen), LY3819469 (Thigh), LY3819469 (Upper Arm) |
Primary outcome
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3819469
Time frame: Day 1 through Day 15
PK: Area Under the Concentration versus Time Curve (AUC) of LY3819469
Time frame: Day 1 through Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3819469 in people with Lipoprotein(a), run by Eli Lilly and Company.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LY3819469 (time frame: Day 1 through Day 15). 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 4 Nov 2026.