A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events ( KRAKEN )

2022-501466-21-00 Protocol J2O-MC-EKBC Therapeutic exploratory (Phase II) Ended

Start 1 Mar 2023 · End 14 Mar 2024 · Status Ended · 3 EU/EEA countries · 13 sites · Protocol J2O-MC-EKBC

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 233
Countries 3
Sites 13

Lipoprotein Disorder

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.

Key facts

Sponsor
Eli Lilly & Co., Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
1 Mar 2023 → 14 Mar 2024
Decision date (initial)
2023-02-09
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Dose response, Efficacy, Pharmacokinetic, Safety

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.

Conditions and MedDRA coding

Lipoprotein Disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Participants must be at least 40 years old and have Lp(a) level≥175 nmol/L at screening.
  2. Have coronary artery disease, stroke or peripheral artery disease, familiar hypercholesterinemia or type 2 diabetes.
  3. Participants if on the following medications must be on stable regimen before participating and through the end of treatment and assessment period: lipidlowering drugs, testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators or growth hormone
  4. A body mass index within the range 18.5 to 40 kilogram/square meter
  5. Males and female of child bearing potential who agree to use highly effective contraception methods or women not of childbearing age

Exclusion criteria 5

  1. Had history of underlying disease or surgical, physical medical or psychiatric condition
  2. Had major surgery within 3 months of randomization
  3. Had coronary, carotid, or peripheral arteria revascularization, stroke, heart attack or chest pain within 3 months of day 1
  4. Have uncontrolled diabetes
  5. Have uncontrolled high blood pressure

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Percent Change from Baseline in Lipoprotein (a) Lp(a) [Time Frame: Baseline to Week 12]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

LY3473329

PRD9964416 · Product

Active substance
LY3473329
Pharmaceutical form
FILM COATED TABLET
Route of administration
ORAL
Max daily dose
240 mg milligram(s)
Max total dose
20160 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

LY3473329

PRD9964406 · Product

Active substance
LY3473329
Pharmaceutical form
FILM COATED TABLET
Route of administration
ORAL
Max daily dose
240 mg milligram(s)
Max total dose
20160 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match LY3473329

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.

137 Total trials 45 Recruiting 84 Ended
Commercial
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 8

OrganisationCity, countryDuties
Cleveland Clinic
ORG-100028017
 Cleveland, United States Other
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States Other
Icon PLC
ORG-100042517
 Dublin 18, Ireland Other
Iqvia Rds Spain S.L.
ORG-100014508
 Madrid, Spain On site monitoring
Q Squared Solutions LLC
ORG-100043195
 Durham, United States Other
Azenta Germany GmbH
ORG-100039257
 Griesheim, Germany Other

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
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 8

OrganisationCity, countryDuties
Cleveland Clinic
ORG-100028017
 Cleveland, United States Other
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States Other
Icon PLC
ORG-100042517
 Dublin 18, Ireland Other
Iqvia Rds Spain S.L.
ORG-100014508
 Madrid, Spain On site monitoring
Q Squared Solutions LLC
ORG-100043195
 Durham, United States Other
Azenta Germany GmbH
ORG-100039257
 Griesheim, Germany Other

Locations

3 EU/EEA countries · 13 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ended 30 4
Hungary Ended 45 7
Netherlands Ended 25 2
Rest of world
Japan, China, Mexico, Australia, Brazil
 — 133 —

Investigational sites

Germany

4 sites · Ended
ClinPhenomics CVC GmbH
N/A, Alfred-Lippmann-Straße 6, Rohrbach, St. Ingbert
Private Practice - Dr. Frank Menzel
Private Practice, Puschkinallee 17, Private Practice - Dr. Frank Menzel, Dessau-Roßlau
Kardiologische Praxis, Diabetologische Schwerpunktpraxis
Private Practice, Schlüsselbergstr. 6, Kardiologische Praxis, Mühldorf am Inn
St Johannes Hospital gGmbH
N/A, Johannesstrasse 9-17, Mitte, Dortmund

Hungary

7 sites · Ended
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Belgyogyaszat- Angiologia-Nefrologiai osztaly, Kardiovaszkularis ambulancia, Nagyvarad Ter 1, 1097, Budapest Ix
University Of Szeged
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Csaladorvosi Intézet es Rendelő, Tisza Lajos Korut 109, 6725, Szeged
Bacs-Kiskun Megyei Korhaz A Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
I. Belgyogyaszat - Kardiologia, Nyiri Ut 38, 6000, Kecskemet
Belvarosi Egeszseghaz Kft.
Belvarosi Egeszseghaz Kft., Platan Sor 2-4, 8900, Zalaegerszeg
Pest Megyei Flor Ferenc Korhaz
V. Belgyogyaszat, Semmelweis Ter 1, 2143, Kistarcsa
Semmelweis University
Semmelweis Egyetem Varosmajori Sziv-es Ergyogyaszati Klinika, Varosmajor Utca 68, Kerulet, Budapest XII
Medifarma-98 Kft.
Medifarma 98 Kft., Praga Utca 3, 4400, Nyiregyhaza

Netherlands

2 sites · Ended
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Cardiology, Tegelseweg 210, 5912 BL, Venlo
Stichting Meander Medisch Centrum
Internal Medicine, Maatweg 3, 3813 TZ, Amersfoort

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2023-03-01 2024-03-12 2023-03-07 2023-11-08
Hungary 2023-03-01 2024-03-08 2023-04-05 2023-11-10
Netherlands 2023-03-28 2024-02-21 2023-05-03 2023-11-03

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

TitleSubmission dateStatusType
J2O-MC-EKBC_Final Summary of Results_2022-501466-21-00
SUM-74279
 2025-03-12T03:52:47 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
J2O-MC-EKBC_Lay Person Summary of Results_2022-501466-21-00 2025-03-05T05:07:49 Submitted Laypersons Summary of Results
J2O-MC-EKBC_Lay Person Summary of Results_2022-501466-21-00_Dutch(Netherlands) 2025-04-17T21:25:15 Submitted Laypersons Summary of Results
J2O-MC-EKBC_Lay Person Summary of Results_2022-501466-21-00_German_Germany 2025-04-17T21:26:50 Submitted Laypersons Summary of Results
J2O-MC-EKBC_Lay Person Summary of Results_2022-501466-21-00_Hungarian_Hungary 2025-04-17T21:28:18 Submitted Laypersons Summary of Results

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) J2O-MC-EKBC_Lay Person Summary of Results_2022-501466-21-00 1
Laypersons summary of results (for publication) J2O-MC-EKBC_Lay Person Summary of Results_2022-501466-21-00_Dutch_Netherlands 1
Laypersons summary of results (for publication) J2O-MC-EKBC_Lay Person Summary of Results_2022-501466-21-00_German_Germany 1
Laypersons summary of results (for publication) J2O-MC-EKBC_Lay Person Summary of Results_2022-501466-21-00_Hungarian_Hungary 1
Summary of results (for publication) J2O-MC-EKBC_Final Summary of Results_2022-501466-21-00 1

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-10-11 Hungary Acceptable
2023-02-06
 2023-02-09
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-02-10 Acceptable
2023-02-06
 2023-02-10
3 NON SUBSTANTIAL MODIFICATION NSM-2 2023-02-15 Acceptable
2023-02-06
 2023-02-15
4 SUBSTANTIAL MODIFICATION SM-2 2023-03-09 Acceptable 2023-05-24
5 SUBSTANTIAL MODIFICATION SM-1 2023-03-10 Acceptable 2023-04-12
6 SUBSTANTIAL MODIFICATION SM-3 2023-03-27 Hungary Acceptable 2023-05-08

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