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

NCT05565742
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
320
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2022-10-20
clinicaltrials.gov
Number of sites
80
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
clinicaltrials.gov
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)
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
Yes
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2024-10-17
clinicaltrials.gov
First posted
2022-10-04
clinicaltrials.gov
Registry last updated
2025-05-28
clinicaltrials.gov
Primary completion date
2023-10-23
clinicaltrials.gov
Start date
2022-10-20
clinicaltrials.gov

Actual participants
320
clinicaltrials.gov
Participants
320
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
80
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05565742
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05565742
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2022-501426-38-00
  • J3L-MC-EZEB
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)