Clinical trial NCT05565742: A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lipoprotein Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-10-04
Enrollment: 320
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over Days 60-180
timeFrame: Baseline, Days 60 - 180
Secondary outcomes:
measure: Percent Change From Baseline in Time Averaged Lp(a) Over Days 240-360
timeFrame: Baseline, Days 240 - 360
measure: Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180
timeFrame: Days 60, 180
measure: 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
measure: Percent Change From Baseline in Lp(a)
timeFrame: Baseline, Days 60, 180, 240, 360, and 540
measure: Percent Change From Baseline in Apolipoprotein B (ApoB)
timeFrame: Baseline, Days 60, 180, 240, 360, and 540
measure: Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
timeFrame: Baseline, Days 60, 180, 240, 360, and 540
measure: 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
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Care Access - 801 South Power Road, Mesa
state: Arizona
city: Pasadena
country: United States
facility: Care Access - South Pasadena
state: California
city: Santa Clarita
country: United States
facility: Care Access - Santa Clarita
state: California
city: Spring Hill
country: United States
facility: Care Access - Spring Hill
state: Florida
city: Sun City
country: United States
facility: Care Access - Pebble Beach Boulevard, Tampa
state: Florida
city: Tamarac
country: United States
facility: Care Access - Tamarac
state: Florida
city: Tampa
country: United States
facility: Care Access - Tampa
state: Florida
city: Lake Charles
country: United States
facility: Care Access - Lake Charles
state: Louisiana
city: Baltimore
country: United States
facility: Care Access - Baltimore
state: Maryland
city: Dorchester
country: United States
facility: Care Access - Dorchester
state: Massachusetts
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Lima
country: United States
facility: Care Access - Lima
state: Ohio
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia Yardley
state: Pennsylvania
city: Rapid City
country: United States
facility: Care Access - Rapid City
state: South Dakota
city: Georgetown
country: United States
facility: Care Access - Georgetown
state: Texas
city: Katy
country: United States
facility: Care Access - Katy
state: Texas
city: Falls Church
country: United States
facility: Virginia Heart
state: Virginia
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Air
city: Buenos Aires
country: Argentina
facility: Glenny Corp. S.A.
state: Ciudad Aut
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Balvanera
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aire
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aire
city: San Miguel de Tucuman
country: Argentina
facility: Centro Modelo de Cardiología
state: Tucumán
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clínicas Tucumán
state: Tucumán
city: Buenos Aires
country: Argentina
facility: CEMEDIC
city: Córdoba
country: Argentina
facility: Hospital San Roque
city: Salta
country: Argentina
facility: Centro Cardiovascular Salta
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones Clinicas del Litoral
city: Sanya
country: China
facility: Third People's Hospital of Hainan Province
state: Hainan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Herlev
country: Denmark
facility: Sanos Clinic
state: Hovedstaden
city: Gandrup
country: Denmark
facility: Sanos Clinic - Nordjylland
state: Nordjylland
city: Vejle
country: Denmark
facility: Sanos Clinic - Syddanmark
state: Syddanmark
city: Spandau
country: Germany
facility: Medizinisches Versorgungszentrum am Bahnhof Spandau
state: Berlin
city: Bad Homburg
country: Germany
facility: Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
state: Hessen
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
state: Hessen
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Mitte
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Kardiologische Praxen im Spreebogen
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Clinical Research Hospital Tokyo
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic
state: Tokyo
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Tijuana
country: Mexico
facility: Centro de Investigacion Cardiovascular y Metabólica
state: Baja California
city: Guadalajara
country: Mexico
facility: Virgen Cardiovascular Research SC
state: Jalisco
city: Culiacán
country: Mexico
facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
state: Sinaloa
city: Aguascalientes
country: Mexico
facility: Fundación Cardiovascular de Aguascalientes A.C.
city: Querétaro
country: Mexico
facility: Centro de Estudios Clínicos de Querétaro (CECLIQ)
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis, locatie Breda Molengracht
state: Noord-Brabant
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Hardenberg
country: Netherlands
facility: Saxenburgh Medisch Centrum
state: Overijssel
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
state: Zuid-Holland
city: Delft
country: Netherlands
facility: Reinier de Graaf Ziekenhuis, locatie Delft
state: Zuid-Holla
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis, locatie D&A Research and Genetics
city: Pitești
country: Romania
facility: Sal Med Srl
state: Argeș
city: Brasov
country: Romania
facility: C.M.D.T.A. Neomed
state: Brașov
city: Bucharest
country: Romania
facility: Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
state: București
city: Bucharest
country: Romania
facility: Centrul Medical Endocrinologie si Diabet Dr. Paveliu
state: București
city: Baia Mare
country: Romania
facility: Private Practice - Dr. Mercea Corina Delia
state: Maramureș
city: Târgu Mureș
country: Romania
facility: Cardiomed
state: Mureș
city: Târgu-Mureș
country: Romania
facility: Private Practice - Dr. Cristian Podoleanu
state: Mureș
city: Timisoara
country: Romania
facility: Centrul Medical Medicalis
state: Timiș
city: Iași
country: Romania
facility: Cardiomed Iași
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona [Barcelona]
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Catalunya [Cataluña]
city: Granada
country: Spain
facility: Hospital Unviersitario Virgen Nieves
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: