> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/a-study-of-ly3819469-in-participants-with-elevated-e06eb494-8b89-4757-9b4c-e00000b0e581
> Record changed: 2026-10-13

# A Study of LY3819469 in Participants With Elevated Lipoprotein(a) \[Lp(a)\]

NCT05565742

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

Participants

320

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

Lead sponsor

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

Start date

2022-10-20

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

Number of sites

80

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Title and summary

**Summary**

The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Short title**

A Study of LY3819469 in Participants With Elevated Lipoprotein(a) \[Lp(a)\]

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Official title**

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3819469 in Adults With Elevated Lipoprotein(a)

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Registry reports results**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Dates

**Completion date**

2024-10-17

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**First posted**

2022-10-04

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Registry last updated**

2025-05-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Primary completion date**

2023-10-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Start date**

2022-10-20

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Size and sites

**Actual participants**

320

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Participants**

320

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Protocol amendments**

3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Number of sites**

80

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Lead sponsor**

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Identifiers

**Registry ID**

NCT05565742

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**ClinicalTrials.gov ID**

NCT05565742

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Outcomes

### Primary outcomes

1. Percent Change From Baseline in Time Averaged Lipoprotein(a) \[Lp(a)\] Over Days 60-180  
Timeframe: Baseline, Days 60 - 180  
LPa levels were assessed using Immuno turbidimetric method. Percent change is calculated as: Percent Change=\\\[(Lp(a) at Time Point-Lp(a) at Baseline)/Lp(a) at Baseline\\\]×100 Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as post-baseline measures. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.

### Secondary outcomes

1. Percent Change From Baseline in Time Averaged Lp(a) Over Days 240-360  
Timeframe: Baseline, Days 240 - 360  
LPa levels were assessed using Immuno turbidimetric method. LS mean was determined using MMRM model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as post-baseline measures.. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.
2. Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180  
Timeframe: Days 60, 180  
Percentage of Participants Achieving Lp(a) \\<125 and \\<75 Nanomole/Liter (nmol/L) at Days 60, 180 is reported.
3. Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540  
Timeframe: Days 240, 360, and 540  
Percentage of Participants Achieving Lp(a) \\<125 and \\<75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540 is reported.
4. Percent Change From Baseline in Lp(a)  
Timeframe: Baseline, Days 60, 180, 240, 360, and 540  
LS mean was determined using MMRM model with log(Actual Measurement/Baseline) = log (Baseline) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment\\\*Time (Type III sum of squares) as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.
5. Percent Change From Baseline in Apolipoprotein B (ApoB)  
Timeframe: Baseline, Days 60, 180, 240, 360, and 540  
LS mean was determined using MMRM model with log (Actual Measurement/Baseline) = log(Baseline) + Baseline Lp(a) stratum (\\<275 nmol/L vs. \\>=275 nmol/L) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment\\\*Time (Type III sum of squares as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.
6. Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)  
Timeframe: Baseline, Days 60, 180, 240, 360, and 540  
hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation. LS mean was determined using MMRM model with log (Actual Measurement/Baseline) = log(Baseline) + Baseline Lp(a) stratum (\\<275 nmol/L vs. \\>=275 nmol/L) + High Risk CV Stratum (yes/no) + Treatment + Time + Treatment\\\*Time (Type III sum of squares as post-baseline measures. Variance-Covariance structure (Change from Baseline) = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.
7. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC\[0-inf\]) of LY3819469  
Timeframe: Day 1: 0.5 hours, 4-9 hours post-dose; Day 180: 24-36 hours post-dose  
AUC was computed using the population PK model. Therefore, the concentrations are simulated from time 0 to infinity to estimate AUC for each participant. The timeframe reflects the PK timepoints that were collected to develop the population PK. Although this is a multiple dose study, the plasma PK is very short, so AUC0-180days is equivalent to AUC0-infinity.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

40 Years

**Healthy volunteers**

No

### Inclusion criteria

- Participants must be at least 40 years old at the time of signing the informed consent.
- Participants with Lp(a) ≥175 nmol/L at screening, measured at the central laboratory
- Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to screening and randomization and expected to remain on a stable regimen through the end of the Treatment and Assessment Period:

  - lipid-lowering drugs
  - testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
  - Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.

Male and/or Female

- Males who agree to use highly effective/effective methods of contraception may participate in this trial.
- Women not of childbearing potential (WNOCBP) may participate in this trial.

### Exclusion criteria

- Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
- Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:

  - major surgery
  - coronary, carotid, or peripheral arterial revascularization
  - stroke or transient ischemic attack
  - myocardial infarction or unstable angina
  - acute limb ischemia
- Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes.
- Have uncontrolled hypertension

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Sites

- Care Access - 801 South Power Road, MesaMesa, United States
- Care Access - South PasadenaPasadena, United States
- Care Access - Santa ClaritaSanta Clarita, United States
- Care Access - Spring HillSpring Hill, United States
- Care Access - Pebble Beach Boulevard, TampaSun City, United States
- Care Access - TamaracTamarac, United States
- Care Access - TampaTampa, United States
- Care Access - Lake CharlesLake Charles, United States
- Care Access - BaltimoreBaltimore, United States
- Care Access - DorchesterDorchester, United States
- Aventiv Research IncColumbus, United States
- Care Access - LimaLima, United States
- Capital Area Research, LLCCamp Hill, United States
- Lancaster General HospitalLancaster, United States
- Cardiology Consultants of Philadelphia YardleyYardley, United States
- Care Access - Rapid CityRapid City, United States
- Care Access - GeorgetownGeorgetown, United States
- Care Access - KatyKaty, United States
- Virginia HeartFalls Church, United States
- Mautalen Salud e InvestigaciónBuenos Aires, Argentina
- Centro de Investigaciones Metabólicas (CINME)Ciudad Autónoma de Buenos Aire, Argentina
- Glenny Corp. S.A.Buenos Aires, Argentina
- Investigaciones Medicas Imoba SrlBalvanera, Argentina
- CIPRECBuenos Aires, Argentina
- Centro Modelo de CardiologíaSan Miguel de Tucumán, Argentina

And 55 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## References

- PubMed 40162643  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40162643/)
Related publication
- PubMed 38970537  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38970537/)
Related publication
- PubMed 38415744  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38415744/)
Related publication

- Related resource (trials.lilly.com)  
Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/363038)

### Other registry identifiers (2)

- 2022-501426-38-00
- J3L-MC-EZEB

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05565742)

## Related records

### Drugs (1)

- [Lepodisiran](https://trialight.com/data/asset/lepodisiran-8b0f52c0-9390-4d13-a122-cdbe797db75f.md)

### Lead sponsors (1)

- [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md)

### Conditions (1)

- [Multisystem inflammatory syndrome in children and adults](https://trialight.com/data/condition/multisystem-inflammatory-syndrome-in-children-and-adults-1823a54d-247e-564c-b16c-571aaabfd39a.md) Primary condition

---

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