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

Lipoprotein Disorder Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05565742
• Other study ID #: 18547
• Secondary ID: J3L-MC-EZEB
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 20, 2022
• Est. completion date: October 18, 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: October 18, 2024
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lipoprotein Disorder

Intervention

Drug:
• LY3819469
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	CEMEDIC	Buenos Aires
Argentina	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aire
Argentina	Glenny Corp	Buenos Aires	Ciudad Aut
Argentina	Investigaciones Medicas Imoba Srl	Buenos Aires	Ciudad Autónoma De Buenos Aire
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Air
Argentina	Hospital San Roque	Córdoba
Argentina	Centro Cardiovascular Salta	Salta
Argentina	Centro Modelo de Cardiología	San Miguel de Tucuman	Tucumán
Argentina	Investigaciones Clínicas Tucumán	San Miguel de Tucuman	Tucumán
Argentina	Centro de Investigaciones Clinicas del Litoral	Santa Fe
China	The Third Hospital of Nanchang	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Third People's Hospital of Hainan Province	Sanya	Hainan
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
Denmark	Sanos Clinic - Nordjylland	Aalborg	Nordjylland
Denmark	Sanos Clinic	Herlev	Hovedstaden
Denmark	Sanos Clinic - Syddanmark	Vejle	Syddanmark
Germany	Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair	Bad Homburg	Hessen
Germany	Kardiologische Praxen im Spreebogen	Berlin
Germany	Klinikum Bielefeld Mitte	Bielefeld	Nordrhein-Westfalen
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt	Hessen
Germany	Cardiologicum Hamburg	Hamburg
Germany	Diabeteszentrum Hamburg West	Hamburg
Germany	SMO.MD GmbH	Magdeburg	Sachsen-Anhalt
Germany	Medizinisches Versorgungszentrum am Bahnhof Spandau	Spandau	Berlin
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	Rinku General Medical Center	Izumisano	Osaka
Japan	Miyazaki Medical Association Hospital	Miyazaki
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	AMC Nishiumeda Clinic	Osaka
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo
Japan	Heishinkai Medical Group ToCROM Clinic	Shinjuku-ku	Tokyo
Mexico	Fundación Cardiovascular de Aguascalientes A.C.	Aguascalientes
Mexico	Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.	Culiacán	Sinaloa
Mexico	Virgen Cardiovascular Research SC	Guadalajara	Jalisco
Mexico	Centro de Estudios Clínicos de Querétaro (CECLIQ)	Querétaro
Mexico	Centro de Investigacion Cardiovascular y Metabólica	Tijuana	Baja California
Netherlands	Amphia Ziekenhuis, locatie Breda Molengracht	Breda	Noord-Brabant
Netherlands	Reinier de Graaf Ziekenhuis, locatie Delft	Delft	Zuid-Holla
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	Groene Hart Ziekenhuis	Gouda	Zuid-Holland
Netherlands	Saxenburgh Medisch Centrum	Hardenberg	Overijssel
Netherlands	Antonius Ziekenhuis, locatie D&A Research and Genetics	Sneek
Romania	Private Practice - Dr. Mercea Corina Delia	Baia Mare	Maramure?
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	Centrul Medical Endocrinologie si Diabet Dr. Paveliu	Bucharest	Bucure?ti
Romania	Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului	Bucharest	Bucure?ti
Romania	Cardiomed Ia?i	Ia?i
Romania	Sal Med Srl	Pite?ti	Arge?
Romania	Cardiomed	Târgu Mure?	Mure?
Romania	Private Practice - Dr. Cristian Podoleanu	Târgu-Mure?	Mure?
Romania	Centrul Medical Medicalis	Timisoara	Timi?
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona [Barcelona]
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucía
Spain	Hospital Unviersitario Virgen Nieves	Granada
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Catalunya [Cataluña]
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza
United States	Care Access - Baltimore	Baltimore	Maryland
United States	Capital Area Research, LLC	Camp Hill	Pennsylvania
United States	Aventiv Research Inc	Columbus	Ohio
United States	Care Access - Dorchester	Dorchester	Massachusetts
United States	Virginia Heart	Falls Church	Virginia
United States	Care Access - Georgetown	Georgetown	Texas
United States	Care Access - Katy	Katy	Texas
United States	Care Access - Lake Charles	Lake Charles	Louisiana
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Care Access - Lima	Lima	Ohio
United States	Care Access - 801 South Power Road, Mesa	Mesa	Arizona
United States	Care Access - South Pasadena	Pasadena	California
United States	Care Access - Rapid City	Rapid City	South Dakota
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	Cardiology Consultants of Philadelphia Yardley	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  China,  Denmark,  Germany,  Japan,  Mexico,  Netherlands,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Time Averaged Lipoprotein(a) [Lp(a)]		Baseline, Days 60 - 180
Secondary	Percent Change from Baseline in Time Averaged Lp(a)		Baseline, 240 - 360
Secondary	Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (nmol/L)		Days 60, 180, 240, 360, and 540
Secondary	Percent Change from Baseline in Lp(a)		Baseline to Days 60, 180, 240, 360, and 540
Secondary	Percent Change from Baseline in Apolipoprotein B (ApoB)		Baseline to Days 60, 180, 240, 360, and 540
Secondary	Percent Change from Baseline in High-sensitivity C-reactive Protein (hsCRP)		Baseline to Days 60, 180, 240, 360, and 540
Secondary	Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3819469	Population PK parameters will be assessed by AUC	Baseline to Day 540

External Links

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