Phase 2
Completed N=320
A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
Lipoprotein Disorder
Source: ClinicalTrials.gov NCT05565742 ↗
Enrolled (actual)
320
Serious AEs
10.9%
Results posted
May 2025
Primary outcomePrimary: Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over Days 60-180 — -39.0; -74.4; -93.7; 3.1 percent change — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over Days 60-180 |
-39.0; -74.4; -93.7; 3.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Time Averaged Lp(a) Over Days 240-360 |
-38.7; -77.4; -95.0; -76.7; 0.3 | 0.002 sig |
| SECONDARY Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180 |
37.14; 86.30; 97.81; 0.00; 14.29; 58.33 | 0.001 sig |
| SECONDARY Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540 |
36.36; 88.06; 98.41; 78.79; 1.56; 24.24 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lp(a) |
-46.2; -80.4; -95.4; -95.4; 2.2; -30.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (ApoB) |
-10.2; -11.8; -13.9; -13.9; 0.2; -7.0 | 0.010 sig |
| SECONDARY Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) |
-15.4; 0.1; -1.9; -1.9; 2.1; 10.6 | 0.353 |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3819469 |
1853; 10110; 55242; 46633 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05565742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.