AzTrials
AzTrials

Lipoprotein DisorderPhase 2NCT05565742

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

A Phase 2 study testing LY3819469 in people with Lipoprotein Disorder, run by Eli Lilly and Company at 80 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Lipoprotein Disorder
What is being tested?
LY3819469
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
80 sitesin 10 countries
Study dates
20 Oct 2022to 17 Oct 2024
Phase
Phase 2

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • acute limb ischemia
  • Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes.
  • Have uncontrolled hypertension

Trial locations and contacts

80 sites in 10 countries.

80 sites in 10 countries

United States19 sites

  • Care Access - Baltimore

    Baltimore, Maryland, 21213

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Aventiv Research Inc

    Columbus, Ohio, 43213

  • Care Access - Dorchester

    Dorchester, Massachusetts, 02124

  • Virginia Heart

    Falls Church, Virginia, 22042

  • Care Access - Georgetown

    Georgetown, Texas, 78633

  • Care Access - Katy

    Katy, Texas, 77450

  • Care Access - Lake Charles

    Lake Charles, Louisiana, 70601

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Care Access - Lima

    Lima, Ohio, 45805

  • Care Access - 801 South Power Road, Mesa

    Mesa, Arizona, 85206

  • Care Access - South Pasadena

    Pasadena, California, 91105

  • Care Access - Rapid City

    Rapid City, South Dakota, 57701

  • Care Access - Santa Clarita

    Santa Clarita, California, 91321

  • Care Access - Spring Hill

    Spring Hill, Florida, 34609

  • Care Access - Pebble Beach Boulevard, Tampa

    Sun City, Florida, 33573

  • Care Access - Tamarac

    Tamarac, Florida, 33321

  • Care Access - Tampa

    Tampa, Florida, 33625

  • Cardiology Consultants of Philadelphia Yardley

    Yardley, Pennsylvania, 19067

Other trials in United States

Argentina11 sites

  • Investigaciones Medicas Imoba Srl

    Balvanera, Ciudad Autónoma de Buenos Aire, C1056ABH

  • Mautalen Salud e Investigación

    Buenos Aires, Buenos Aires F.D., C1128AAF

  • Glenny Corp. S.A.

    Buenos Aires, Ciudad Aut, C1430CKE

  • CIPREC

    Buenos Aires, Ciudad Autónoma de Buenos Aire, C1061AAS

  • CEMEDIC

    Buenos Aires, 1407

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Air, C1027AAP

  • Hospital San Roque

    Córdoba, 5000

  • Centro Cardiovascular Salta

    Salta, 4406

  • Centro Modelo de Cardiología

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigaciones Clínicas Tucumán

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro de Investigaciones Clinicas del Litoral

    Santa Fe, 3000

Other trials in Argentina

Japan9 sites

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577

  • Miyazaki Medical Association Hospital

    Miyazaki, 880-2102

  • Hyogo Medical University Hospital

    Nishinomiya, Hyōgo, 663-8501

  • AMC Nishiumeda Clinic

    Osaka, 530-0001

  • Kitasato University Hospital

    Sagamihara, Kanagawa, 252-0375

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, 160-0004

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008

Other trials in Japan

Romania9 sites

  • Private Practice - Dr. Mercea Corina Delia

    Baia Mare, Maramureş, 430123

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 500283

  • Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului

    Bucharest, Bucharest, 011053

  • Centrul Medical Endocrinologie si Diabet Dr. Paveliu

    Bucharest, Bucharest, 50538

  • Cardiomed Iași

    Iași, 700687

  • Sal Med Srl

    Piteşti, Argeş, 110437

  • Cardiomed

    Târgu Mureş, Mureș County, 540124

  • Private Practice - Dr. Cristian Podoleanu

    Târgu Mureş, Mureș County, 540143

  • Centrul Medical Medicalis

    Timișoara, Timiș County, 300462

Other trials in Romania

Germany8 sites

  • Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair

    Bad Homburg, Hesse, 61348

  • Kardiologische Praxen im Spreebogen

    Berlin, 10559

  • Klinikum Bielefeld Mitte

    Bielefeld, North Rhine-Westphalia, 33604

  • Cardioangiologisches Centrum Bethanien

    Frankfurt am Main, Hesse, 60389

  • Cardiologicum Hamburg

    Hamburg, 22041

  • Diabeteszentrum Hamburg West

    Hamburg, 22607

  • SMO.MD GmbH

    Magdeburg, Saxony-Anhalt, 39120

  • Medizinisches Versorgungszentrum am Bahnhof Spandau

    Spandau, State of Berlin, 13597

Other trials in Germany

Netherlands6 sites

  • Amphia Ziekenhuis, locatie Breda Molengracht

    Breda, North Brabant, 4818 CK

  • Reinier de Graaf Ziekenhuis, locatie Delft

    Delft, Zuid-Holla, 2625 AD

  • Medisch Spectrum Twente

    Enschede, Overijssel, 7512 KZ

  • Groene Hart Ziekenhuis

    Gouda, South Holland, 2803HH

  • Saxenburgh Medisch Centrum

    Hardenberg, Overijssel, 7772 SE

  • Antonius Ziekenhuis, locatie D&A Research and Genetics

    Sneek, 8601 ZR

Other trials in Netherlands

Spain6 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona [Barcelona], 08916

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Hospital Unviersitario Virgen Nieves

    Granada, 18014

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Mexico5 sites

  • Fundación Cardiovascular de Aguascalientes A.C.

    Aguascalientes, 20230

  • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

    Culiacán, Sinaloa, 80230

  • Virgen Cardiovascular Research SC

    Guadalajara, Jalisco, 44670

  • Centro de Estudios Clínicos de Querétaro (CECLIQ)

    Querétaro, 76000

  • Centro de Investigacion Cardiovascular y Metabólica

    Tijuana, Estado de Baja California, 22500

Other trials in Mexico

China4 sites

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330009

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Third People's Hospital of Hainan Province

    Sanya, Hainan, 572000

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

Other trials in China

Denmark3 sites

  • Sanos Clinic - Nordjylland

    Gandrup, North Denmark, 9362

  • Sanos Clinic

    Herlev, Capital Region, 2730

  • Sanos Clinic - Syddanmark

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

About this study

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)

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.

Being tested
LY3819469, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3819469Drug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05565742
Study groupRoleWhat they receive
16 mg LY3819469ExperimentalParticipants received 16 milligrams (mg) of LY3819469 on day 1 and day 180, administered as a subcutaneous (SC) injection.
Receives: Drug: LY3819469
96 mg LY3819469ExperimentalParticipants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
Receives: Drug: LY3819469
400 mg LY3819469ExperimentalParticipants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
Receives: Drug: LY3819469
400 mg LY3819469 + PlaceboExperimentalParticipants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
Receives: Drug: LY3819469; Drug: Placebo
PlaceboPlacebo comparatorParticipants received placebo on day 1 and day 180, administered as a SC injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over 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.

    Measured: Baseline, Days 60 - 180

Secondary outcomes (7)

  1. Percent Change From Baseline in Time Averaged Lp(a) Over 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.

    Measured: Baseline, Days 240 - 360

  2. Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180

    Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (nmol/L) at Days 60, 180 is reported.

    Measured: Days 60, 180

  3. Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at 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.

    Measured: Days 240, 360, and 540

  4. Percent Change From Baseline in Lp(a)

    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.

    Measured: Baseline, Days 60, 180, 240, 360, and 540

  5. Percent Change From Baseline in Apolipoprotein B (ApoB)

    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.

    Measured: Baseline, Days 60, 180, 240, 360, and 540

  6. Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)

    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.

    Measured: Baseline, Days 60, 180, 240, 360, and 540

  7. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3819469

    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.

    Measured: Day 1: 0.5 hours, 4-9 hours post-dose; Day 180: 24-36 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start20 Oct 2022
  3. Primary completion23 Oct 2023
  4. Study completion17 Oct 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565742
Sponsor's protocol ID
18547
Other IDs
J3L-MC-EZEB, 2022-501426-38-00
Status last verified
May 2025
First submitted
3 Oct 2022
Last updated
28 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Nissen SE, Navar AM, Krege JH, Ni W, St John J, Nicholls SJ, Shen X, Wolski K, Michael LF. Effect on Lipoprotein(a) Oxidized Phospholipids of Lepodisiran, an Extended-Duration siRNA Targeting Lipoprotein(a). J Am Coll Cardiol. 2026 Aug 31:S0735-1097(26)07140-8. doi: 10.1016/j.jacc.2026.07.015. Online ahead of print.

    PubMed 42671367

  • Nissen SE, Ni W, Shen X, Wang Q, Navar AM, Nicholls SJ, Wolski K, Michael L, Haupt A, Krege JH; ALPACA Trial Investigators. Lepodisiran - A Long-Duration Small Interfering RNA Targeting Lipoprotein(a). N Engl J Med. 2025 May 1;392(17):1673-1683. doi: 10.1056/NEJMoa2415818. Epub 2025 Mar 30.

    PubMed 40162643

  • Makhmudova U, Steinhagen-Thiessen E, Volpe M, Landmesser U. Advances in nucleic acid-targeted therapies for cardiovascular disease prevention. Cardiovasc Res. 2024 Sep 2;120(10):1107-1125. doi: 10.1093/cvr/cvae136.

    PubMed 38970537

  • Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.

    PubMed 38415744

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in