A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
Completed · Phase 2 · Has a placebo group
Conditions studied: Lipoprotein Disorder
In brief
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.
Key facts
- Study ID
- NCT05565742
- Run by
- Eli Lilly and Company
- People needed
- 320
- Starts
- 2022-10-20
- Expected to finish
- 2024-10-17
- Last updated by the study team
- 2025-05-28
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Care Access - South Pasadena — Pasadena, California, United States
- Care Access - Santa Clarita — Santa Clarita, California, United States
- Care Access - Spring Hill — Spring Hill, Florida, United States
- Care Access - Pebble Beach Boulevard, Tampa — Sun City, Florida, United States
- Care Access - Tamarac — Tamarac, Florida, United States
- Care Access - Tampa — Tampa, Florida, United States
- Care Access - Lake Charles — Lake Charles, Louisiana, United States
- Care Access - Baltimore — Baltimore, Maryland, United States
- Care Access - Dorchester — Dorchester, Massachusetts, United States
- Aventiv Research Inc — Columbus, Ohio, United States
- Care Access - Lima — Lima, Ohio, United States
- Capital Area Research, LLC — Camp Hill, Pennsylvania, United States
- Lancaster General Hospital — Lancaster, Pennsylvania, United States
- Cardiology Consultants of Philadelphia Yardley — Yardley, Pennsylvania, United States
- Care Access - Rapid City — Rapid City, South Dakota, United States
- Care Access - Georgetown — Georgetown, Texas, United States
- Care Access - Katy — Katy, Texas, United States
- Virginia Heart — Falls Church, Virginia, United States
- Mautalen Salud e Investigación — Buenos Aires, Buenos Aires F.D., Argentina
- Centro de Investigaciones Metabólicas (CINME) — Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
- Glenny Corp. S.A. — Buenos Aires, Ciudad Aut, Argentina
- Investigaciones Medicas Imoba Srl — Balvanera, Ciudad Autónoma de Buenos Aire, Argentina
- CIPREC — Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
- Centro Modelo de Cardiología — San Miguel de Tucumán, Tucumán Province, Argentina
- Care Access - 801 South Power Road, Mesa — Mesa, Arizona, United States
Full record on ClinicalTrials.gov
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