A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
- Registration Number
- NCT05563246
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of LY3473329 in adult participants with elevated Lp(a) at high risk for cardiovascular events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 233
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Participants must be at least 40 years old
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Participants with Lp(a) ≥175 nmol/L at randomization, measured at the central laboratory.
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High risk for cardiovascular events defined as documented coronary artery disease (CAD), stroke, or peripheral artery disease or atherosclerotic cardiovascular disease (ASCVD) risk equivalents (familial hypercholesterolemia or type 2 diabetes).
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Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to randomization and expected to remain on a stable regimen through the end of the post-treatment follow-up period.
- lipid-lowering drugs
- testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
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Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.
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Males who agree to use highly effective or effective methods of contraception may participate in this trial.
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Women of childbearing potential (WOCBP) who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial.
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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.
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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
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Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes
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Have uncontrolled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mg LY3473329 LY3473329 Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period. 60 mg LY3473329 LY3473329 Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period. 240 mg LY3473329 LY3473329 Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period. Placebo Placebo Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay Baseline, Week 12 Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.
Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay Baseline, Week 12 LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay Week 12 The percentage of participants who achieved Lp(a) less than (\<) 125 nmol/L, as measured using the intact Lp(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay Week 12 The percentage of participants who achieved Lp(a) \< 125 nmol/L, as measured using the apo(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.
Percent Change From Baseline in Apolipoprotein B (ApoB) Baseline, Week 12 LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment\*Time.
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Baseline, Week 12 LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment\*Time.
Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329 Week from randomization 1, 2, 8, 12: Pre-dose C-trough were measured at specified time points to assess the minimum concentration of LY3473329 in the blood before the next dose was administered.
Trial Locations
- Locations (42)
Care Access - Baltimore
🇺🇸Baltimore, Maryland, United States
Nightingale Research
🇦🇺Adelaide, South Australia, Australia
Care Access - Dorchester
🇺🇸Dorchester, Massachusetts, United States
Core Research Group
🇦🇺Brisbane, Queensland, Australia
Instituto Dante Pazzanese de Cardiology
🇧🇷São Paulo, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
🇧🇷Rio de Janeiro, Brazil
Private Practice - Dr. Frank Menzel
🇩🇪Dessau, Germany
Care Access - Lima
🇺🇸Lima, Ohio, United States
CEPIC - Centro Paulista de Investigação Clínica
🇧🇷São Paulo, Brazil
ClinPhenomics GmbH & Co KG
🇩🇪Frankfurt, Hessen, Germany
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
Minamino Cardiovascular Hospital
🇯🇵Hachioji, Tokyo, Japan
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
CPCLIN
🇧🇷Sao Paulo, Brazil
Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte
🇩🇪Mühldorf, Bayern, Germany
Kath. St.-Johannes-Gesellschaft Dortmund
🇩🇪Dortmund, Nordrhein-Westfalen, Germany
Iwate Prefectural Central Hospital
🇯🇵Morioka, Iwate, Japan
Miyazaki Medical Association Hospital
🇯🇵Miyazaki, Japan
Third People's Hospital of Hainan Province
🇨🇳Sanya, Hainan, China
The First Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The Fourth Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Changzhou Second People's Hospital
🇨🇳Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The Third Hospital of Nanchang
🇨🇳Nanchang, Jiangxi, China
China-Japan Union Hospital
🇨🇳Changchun, Jilin, China
CEDOES
🇧🇷Vitória, Espírito Santo, Brazil
Centro de Pesquisa Clinica do Coracao
🇧🇷Acaraju, Sergipe, Brazil
Medifarma 98 Kft
🇭🇺Nyiregyhaza, Nyíregyháza, Hungary
Flor Ferenc Hospital of Pest County
🇭🇺Kistarcsa, Pest, Hungary
Victorian Heart Hospital
🇦🇺Clayton, Victoria, Australia
Semmelweis University
🇭🇺Budapest, Hungary
VieCuri Medisch Centrum, locatie Venlo
🇳🇱Venlo, Limburg, Netherlands
Dél-Pesti Centrumkórház
🇭🇺Budapest, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
Pesquisa Clínica em Diabetes - Dra Rosângela Réa
🇧🇷Curitiba, Paraná, Brazil
Meander Medisch Centrum
🇳🇱Amersfoort, Utrecht, Netherlands
Incor - Instituto do Coracao
🇧🇷Sao Paulo, São Paulo, Brazil
Belvárosi Egészségház
🇭🇺Zalaegerszeg, Zala, Hungary
Funabashi Municipal Medical Center
🇯🇵Funabashi, Chiba, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Hiroshima City Hospital
🇯🇵Hiroshima, Japan