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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05565742
Collaborator
(none)
254
Enrollment
82
Locations
5
Arms
24
Anticipated Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
254 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Oct 20, 2022
Anticipated Primary Completion Date :
Oct 21, 2023
Anticipated Study Completion Date :
Oct 18, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3819469 Dose 1

Participants will receive LY3819469 subcutaneously (SC).

Drug: LY3819469
Administered SC
Experimental: LY3819469 Dose 2

Participants will receive LY3819469 SC.

Drug: LY3819469
Administered SC
Experimental: LY3819469 Dose 3

Participants will receive LY3819469 SC.

Drug: LY3819469
Administered SC
Experimental: LY3819469 Dose 4 + Placebo

Participants will receive LY3819469 SC and placebo.

Drug: LY3819469
Administered SC

Drug: Placebo
Administered SC
Placebo Comparator: Placebo

Participants will receive placebo.

Drug: Placebo
Administered SC

Outcome Measures

Primary Outcome Measures

  1. Percent Change from Baseline in Time Averaged Lipoprotein(a) [Lp(a)] [Baseline, Days 60 - 180]

Secondary Outcome Measures

  1. Percent Change from Baseline in Time Averaged Lp(a) [Baseline, 240 - 360]

  2. Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (nmol/L) [Days 60, 180, 240, 360, and 540]

  3. Percent Change from Baseline in Lp(a) [Baseline to Days 60, 180, 240, 360, and 540]

  4. Percent Change from Baseline in Apolipoprotein B (ApoB) [Baseline to Days 60, 180, 240, 360, and 540]

  5. Percent Change from Baseline in High-sensitivity C-reactive Protein (hsCRP) [Baseline to Days 60, 180, 240, 360, and 540]

  6. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3819469 [Baseline to Day 540]

    Population PK parameters will be assessed by AUC

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Care Access - 801 South Power Road, Mesa Mesa Arizona United States 85206
2 Care Access - South Pasadena Pasadena California United States 91105
3 Care Access - Santa Clarita Santa Clarita California United States 91321
4 Care Access - Spring Hill Spring Hill Florida United States 34609
5 Care Access - Pebble Beach Boulevard, Tampa Sun City Florida United States 33573
6 Care Access - Tamarac Tamarac Florida United States 33321
7 Care Access - Tampa Tampa Florida United States 33625
8 Care Access - Lake Charles Lake Charles Louisiana United States 70601
9 Care Access - Baltimore Baltimore Maryland United States 21213
10 Care Access - Dorchester Dorchester Massachusetts United States 02124
11 Aventiv Research Inc Columbus Ohio United States 43213
12 Care Access - Lima Lima Ohio United States 45805
13 Capital Area Research, LLC Camp Hill Pennsylvania United States 17011
14 Lancaster General Hospital Lancaster Pennsylvania United States 17602
15 Cardiology Consultants of Philadelphia Yardley Yardley Pennsylvania United States 19067
16 Care Access - Rapid City Rapid City South Dakota United States 57701
17 Care Access - Georgetown Georgetown Texas United States 78633
18 Care Access - Katy Katy Texas United States 77450
19 Virginia Heart Falls Church Virginia United States 22042
20 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Air Argentina C1027AAP
21 Glenny Corp Buenos Aires Ciudad Aut Argentina C1430CKE
22 Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1128AAF
23 Investigaciones Medicas Imoba Srl Buenos Aires Ciudad Autónoma De Buenos Aire Argentina C1179AAB
24 CIPREC Caba Ciudad Autónoma De Buenos Aire Argentina C1061AAS
25 Centro Modelo de Cardiología San Miguel de Tucuman Tucumán Argentina 4000
26 Investigaciones Clínicas Tucumán San Miguel de Tucuman Tucumán Argentina 4000
27 CEMEDIC Buenos Aires Argentina 1407
28 Hospital San Roque Córdoba Argentina 5000
29 Centro de Investigaciones Clinicas Instituto del Corazon (CICIC) Córdoba Argentina X5002HWE
30 Centro Cardiovascular Salta Salta Argentina 4406
31 Centro de Investigaciones Clinicas del Litoral Santa Fe Argentina S3000FWO
32 Third People's Hospital of Hainan Province Sanya Hainan China 572000
33 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
34 The Third Hospital of Nanchang Nanchang Jiangxi China 330009
35 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710061
36 Sanos Clinic Herlev Hovedstaden Denmark 2730
37 Sanos Clinic - Nordjylland Aalborg Nordjylland Denmark 9362
38 Sanos Clinic - Syddanmark Vejle Syddanmark Denmark 7100
39 Medizinisches Versorgungszentrum am Bahnhof Spandau Spandau Berlin Germany 13597
40 Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair Bad Homburg Hessen Germany 61348
41 Cardioangiologisches Centrum Bethanien Frankfurt Hessen Germany 60389
42 Klinikum Bielefeld Mitte Bielefeld Nordrhein-Westfalen Germany 33604
43 SMO.MD GmbH Magdeburg Sachsen-Anhalt Germany 39120
44 Kardiologische Praxen im Spreebogen Berlin Germany 10559
45 Cardiologicum Hamburg Hamburg Germany 22041
46 Diabeteszentrum Hamburg West Hamburg Germany 22607
47 Sapporo Medical University Hospital Sapporo Hokkaido Japan 060-8543
48 Hyogo College of Medicine Nishinomiya Hyogo Japan 663-8501
49 Kitasato University Hospital Sagamihara Kanagawa Japan 252-0375
50 Rinku General Medical Center Izumisano Osaka Japan 598-8577
51 Tokyo-Eki Center-building Clinic Chuo-ku Tokyo Japan 103-0027
52 Heishinkai Medical Group ToCROM Clinic Shinjuku-ku Tokyo Japan 160-0008
53 Clinical Research Hospital Tokyo Shinjuku-ku Tokyo Japan 162-0053
54 Miyazaki Medical Association Hospital Miyazaki Japan 880-2102
55 AMC Nishiumeda Clinic Osaka Japan 530-0001
56 Centro de Investigacion Cardiovascular y Metabólica Tijuana Baja California Mexico 22500
57 Private Practice - Dr. Francisco Gerardo Padilla Guadalajara Jalisco Mexico 44670
58 Virgen Cardiovascular Research SC Guadalajara Jalisco Mexico 44670
59 Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. Culiacán Sinaloa Mexico 80230
60 Fundación Cardiovascular de Aguascalientes A.C. Aguascalientes Mexico 20230
61 Investigacion En Salud Y Metabolismo Sc Chihuahua Mexico 31217
62 Amphia Ziekenhuis, locatie Breda Molengracht Breda Noord-Brabant Netherlands 4818 CK
63 Medisch Spectrum Twente Enschede Overijssel Netherlands 7512 KZ
64 Saxenburgh Medisch Centrum Hardenberg Overijssel Netherlands 7772 SE
65 Groene Hart Ziekenhuis Gouda Zuid-Holland Netherlands 2803HH
66 Reinier de Graaf Ziekenhuis, locatie Delft Delft Zuid-Holla Netherlands 2625 AD
67 Antonius Ziekenhuis, locatie D&A Research and Genetics Sneek Netherlands 8601 ZR
68 Sal Med Srl Pitești Argeș Romania 110437
69 C.M.D.T.A. Neomed Brasov Brașov Romania 500283
70 Centrul pentru Studiul Metabolismului Bucharest București Romania 011053
71 Centrul Medical Endocrinologie si Diabet Dr. Paveliu Bucharest București Romania 50538
72 Private Practice - Dr. Mercea Corina Delia Baia Mare Maramureș Romania 430123
73 Cardiomed Târgu Mureș Mureș Romania 540124
74 Private Practice - Dr. Cristian Podoleanu Târgu-Mureș Mureș Romania 540143
75 Centrul Medical Medicalis Timisoara Timiș Romania 300462
76 Cardiomed Iași Iași Romania 700687
77 Hu Reina Sofia Cordoba Andalucía Spain 14004
78 Hospital Germans Trias i Pujol Badalona Barcelona [Barcelona] Spain 08916
79 Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Catalunya [Cataluña] Spain 08907
80 Hospital Unviersitario Virgen Nieves Granada Spain 18014
81 Hospital Universitario Virgen Del Rocio Sevilla Spain 41013
82 Hospital Universitario Miguel Servet Zaragoza Spain 50009

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05565742
Other Study ID Numbers:
  • 18547
  • J3L-MC-EZEB
First Posted:
Oct 4, 2022
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 19, 2023