Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
255
Countries
5
Sites
32
Lipoprotein Disorder
To evaluate if LY3819469 is superior to placebo in percent Lp(a) reduction
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 9 Feb 2023 → 17 Oct 2024
- Decision date (initial)
- 2023-01-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacodynamic, Efficacy, Pharmacokinetic, Safety
To evaluate if LY3819469 is superior to placebo in percent Lp(a) reduction
Conditions and MedDRA coding
Lipoprotein Disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must be at least 40 years old and have Lp(a) level ≥175 nmol/L at screening
- Participants if on lipid-lowering drugs or hormone therapy need to be on stable dose for at least 4 weeks prior to screening
- A body mass index within the range 18.5 to 40 kilogram/square meter
- Males who agree to use highly effective contraception methods or women not of childbearing age
Exclusion criteria 6
- Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that in the opinion of the investigator, would affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
- Had major surgery within 3 months of day 1
- Had coronary, carotid, or peripheral arteria revascularization, stroke, heart attack or chest pain within 3 months of day 1
- Have uncontrolled diabetes
- Have uncontrolled high blood pressure
- Women of childbearing potential
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent change from baseline in time-averaged Lp(a) over Days 60-180
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9918695 · Product
- Active substance
- LY3819469 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 20 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Icon PLC ORG-100042517
|
Dublin 18, Ireland | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Other |
| Iqvia Rds Spain S.L. ORG-100014508
|
Madrid, Spain | On site monitoring |
| Cleveland Clinic ORG-100028017
|
Cleveland, United States | Other |
| Azenta Germany GmbH ORG-100039257
|
Griesheim, Germany | Other |
Locations
5 EU/EEA countries · 32 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 21 | 3 |
| Germany | Ended | 49 | 8 |
| Netherlands | Ended | 25 | 6 |
| Romania | Ended | 15 | 9 |
| Spain | Ended | 15 | 6 |
| Rest of world
China, Japan, Mexico, United States, Argentina
|
— | 130 | — |
Investigational sites
Sanos A/S
n/a, Borgergade 39, 9362, Gandrup
Sanos A/S
N/A, Boulevarden 19g, 7100, Vejle
Sanos A/S
N/A, Herlev Hovedgade 82, 2730, Herlev
Praxisinhaber Dr Ulrich Wendisch Dr Dominik Dahl Und Prof Dr Jens Aberle
N/A, Beselerstraße 2a, Groß Flottbek, Hamburg
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
N/A, Galenstrasse 3, Spandau, Berlin
MVZ CCB Frankfurt Und Main-Taunus GbR
N/A, Im Pruefling 23, Bornheim, Frankfurt Am Main
Smo Md GmbH
N/A, Bierer Weg 9, Leipziger Str., Magdeburg
Cardiologicum Hamburg GbR
N/A, Schlossgarten 7, Marienthal, Hamburg
Klinikum Bielefeld gGmbH
N/A, Teutoburger Strasse 50, Innenstadt, Bielefeld
Praxis Dr. Jungmair
N/A, Louisenstr. 63, 61348, Bad Homburg
Kardiologische Praxis im Spreebogen
N/A, Alt-Moabit 101b, 10559, Berlin
Saxenburgh Medisch Centrum
Cardiology, Jan Weitkamplaan 4a, 7772 SE, Hardenberg
Reinier De Graaf
Research department Cardiology, Reinier De Graafweg 5, 2625 AD, Delft
Amphia Hospital
Research Cardiology, Molengracht 21, 4818 CK, Breda
D & A Research B.V.
D&A Research and Genetics, Hegedyk 9, 8601 ZR, Sneek
Green Heart Hospital
Research Cardiology, Bleulandweg 10, 2803 HH, Gouda
Medisch Spectrum Twente
Thorax centrum Twente, Koningsplein 1, 7512 KZ, Enschede
Societatea Civila Medicala Dr. Paveliu
Endocrinology Department, Strada Dr. Iatropol Panait 24, 050538, Bucharest
Cardiomed S.R.L.
Cardiology Department, Aleea Neculai Tudor C1, 700732, Jassi
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Cardiology Department, Strada Crisului Nr. 1, 500283, Brasov
Sal Med S.R.L.
Cardiology Department, Block P7 Scara E Etaj P, Strada Traian, Pitesti
Medicali`s S.R.L.
Cardiology Department, Strada Cernauti 13, 300362, Timisoara
Hightech Medical Services S.R.L.
Diabetes Department, Sector 1, Alexandra Ioan Cuza Blvd 76, Bucharest
Cmi Dr. Podoleanu Cristian
Cardiology Department, Aleea Cornisa Nr 5, Ap. 4, Targu Mures
Cmi Cardiologie-Dr. Mercea Corina Delia
Cardiology Department, Bulevardul Independentei 10/43, 430123, Baia Mare
Cardiology Department
Cardiology Department, B-dul 22 Decembrie 1989 nr 76-78,, Romania, Targu-Mures
University Hospital Virgen Del Rocio S.L.
Medicina Interna, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Unviersitario Miguel Servet
Unidad de Lípidos, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario Reina Sofia
Medicina Interna, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Virgen De Las Nieves
Medicina Interna, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitari Germans Trias I Pujol
Endocrinología y Nutrición, Ctra. Canyet S/n, Edificio General 1a Planta, Badalona
Bellvitge University Hospital
Medicina Interna, Carretera De La Feixa Llarga S/n, Poligono Industrial De La Zona Ranca De Barcelona, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-02-09 | 2024-09-25 | 2023-02-13 | 2023-03-24 | |
| Germany | 2023-02-09 | 2024-10-04 | 2023-02-09 | 2023-03-24 | |
| Netherlands | 2023-02-09 | 2024-10-04 | 2023-02-14 | 2023-03-24 | |
| Romania | 2023-02-09 | 2024-10-09 | 2023-02-13 | 2023-03-24 | |
| Spain | 2023-02-09 | 2024-10-04 | 2023-02-15 | 2023-03-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00 SUM-79643
|
2025-04-17T17:52:18 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| J3L-MC-EZEB Lay Person Summary of Results 2022-501426-38-00 | 2025-09-30T21:50:55 | Submitted | Laypersons Summary of Results |
| J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_Spanish | 2025-11-05T04:36:12 | Submitted | Laypersons Summary of Results |
| J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_Danish | 2025-11-05T04:38:16 | Submitted | Laypersons Summary of Results |
| J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_Dutch | 2025-11-05T04:39:25 | Submitted | Laypersons Summary of Results |
| J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_German | 2025-11-05T04:40:58 | Submitted | Laypersons Summary of Results |
| J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_Romanian | 2025-11-05T04:42:04 | Submitted | Laypersons Summary of Results |
Documents 19 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | J3L-MC-EZEB Lay Person Summary of Results 2022-501426-38-00 | 1 |
| Laypersons summary of results (for publication) | J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_Danish | 1 |
| Laypersons summary of results (for publication) | J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_Dutch | 1 |
| Laypersons summary of results (for publication) | J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_German | 1 |
| Laypersons summary of results (for publication) | J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_Romanian | 1 |
| Laypersons summary of results (for publication) | J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00_Spanish | 1 |
| Recruitment arrangements (for publication) | EZEB_race_ethnicity_justification_ENG | 1 |
| Recruitment arrangements (for publication) | EZEB_Recruitment_arrangements_ENG | 1 |
| Subject information and informed consent form (for publication) | EZEB_Addendum_ICF_Biomaterial_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | EZEB_Addendum_ICF_Biomaterial_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | EZEB_ICF_patient_reimbursement_DE Final_Redacted | 2 |
| Subject information and informed consent form (for publication) | EZEB_ICF_patient_reimbursement_tc_Redacted | 2 |
| Subject information and informed consent form (for publication) | EZEB_main_ICF_DE_Redacted | 3 |
| Subject information and informed consent form (for publication) | EZEB_main_ICF_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | EZEB_patient_ID_DE | 1 |
| Subject information and informed consent form (for publication) | EZEB_patient_reimbursement_handout_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | EZEB_pre-screening_ICF_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | EZEB_pre-screening_ICF_TC_Redacted | 2 |
| Summary of results (for publication) | J3L-MC-EZEB_Final Summary of Results_2022-501426-38-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-21 | Netherlands | Acceptable with conditions 2023-01-23
|
2023-01-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-04-23 | Netherlands | Acceptable with conditions 2023-01-23
|
2024-04-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-03 | Acceptable with conditions | 2024-09-02 |