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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05563246

Collaborator

(none)

233

Enrollment

Locations

Arms

13.5

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lipoprotein Disorder	Drug: LY3473329 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

233 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

KRAKEN: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Once-Daily LY3473329 in Adults With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

Actual Study Start Date :

Nov 24, 2022

Anticipated Primary Completion Date :

Jan 8, 2024

Anticipated Study Completion Date :

Jan 8, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3473329 Dose 1 Participants will receive LY3473329 orally.	Drug: LY3473329 Administered orally
Experimental: LY3473329 Dose 2 Participants will receive LY3473329 orally.	Drug: LY3473329 Administered orally
Experimental: LY3473329 Dose 3 Participants will receive LY3473329 orally.	Drug: LY3473329 Administered orally
Placebo Comparator: Placebo Participants will receive placebo orally.	Drug: Placebo Administered orally

Outcome Measures

Primary Outcome Measures

Percent Change from Baseline in Lipoprotein (a) Lp(a) [Baseline to Week 12]

Secondary Outcome Measures

Percentage of Participants Achieving Lp(a) <125 Nanomole/Liter (nmol/L) [Week 12]
Percent Change from Baseline for Apolipoprotein B (ApoB) [Baseline, Week 12]
Percent Change from Baseline for High Sensitivity C-reactive (hsCRP) [Baseline, Week 12]
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3473329 [Baseline to Week 12]
PK Ctrough of LY34723329 will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants must be at least 40 years old
Participants with Lp(a) ≥175 nmol/L at randomization, measured at the central laboratory.
High risk for cardiovascular events defined as documented coronary artery disease (CAD), stroke, or peripheral artery disease or atherosclerotic cardiovascular disease (ASCVD) risk equivalents (familial hypercholesterolemia or type 2 diabetes).
Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to randomization and expected to remain on a stable regimen through the end of the post-treatment follow-up 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.
Males who agree to use highly effective or effective methods of contraception may participate in this trial.
Women of childbearing potential (WOCBP) who agree to use highly effective or effective methods of contraception and 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	Liverpool Hospital	Liverpool	New South Wales	Australia	2170
2	Core Research Group	Brisbane	Queensland	Australia	4064
3	Nightingale Research	Adelaide	South Australia	Australia	5000
4	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
5	Monash Health	Clayton	Victoria	Australia	3168
6	CEDOES	Vitória	Espírito Santo	Brazil	29055450
7	Quanta Diagnóstico e Terapia	Curitiba	Paraná	Brazil	80040-110
8	Centro de Pesquisa Clinica do Coracao	Acaraju	Sergipe	Brazil	49055-530
9	CPCLIN	Sao Paulo	São Paulo	Brazil	01228-200
10	Incor - Instituto do Coracao	Sao Paulo	São Paulo	Brazil	05403-900
11	IBPClin - Instituto Brasil de Pesquisa Clínica	Rio de Janeiro		Brazil	20241-180
12	Instituto Dante Pazzanese de Cardiology	São Paulo		Brazil	04012-909
13	CEPIC - Centro Paulista de Investigação Clínica	São Paulo		Brazil	04266-010
14	Third People's Hospital of Hainan Province	Sanya	Hainan	China	572000
15	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
16	Changzhou Second People's Hospital	Changzhou	Jiangsu	China	213000
17	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210011
18	The Third Hospital of Nanchang	Nanchang	Jiangxi	China	330009
19	China-Japan Union Hospital	Changchun	Jilin	China	130033
20	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061
21	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang	China	310016
22	Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte	Mühldorf	Bayern	Germany	84453
23	ClinPhenomics CVC GmbH	Frankfurt	Hessen	Germany	60596
24	St.-Johannes-Hospital Dortmund	Dortmund	Nordrhein-Westfalen	Germany	44137
25	Private Practice - Dr. Frank Menzel	Dessau		Germany	06846
26	Bacs-Kiskun Megyei Korhaz	Kecskemét	Bács-Kiskun	Hungary	6000
27	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged	Csongrád	Hungary	6720
28	Medifarma 98 Kft	Nyiregyhaza	Nyíregyháza	Hungary	4400
29	Flor Ferenc Hospital of Pest County	Kistarcsa	Pest	Hungary	2143
30	Belvárosi Egészségház	Zalaegerszeg	Zala	Hungary	8900
31	Dél-Pesti Centrumkórház	Budapest		Hungary	1097
32	Semmelweis Egyetem	Budapest		Hungary	1122
33	Funabashi Municipal Medical Center	Funabashi	Chiba	Japan	273-0853
34	Kokura Memorial Hospital	Kitakyushu	Fukuoka	Japan	802-8555
35	Iwate Prefectural Central Hospital	Morioka	Iwate	Japan	020-0066
36	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka	Japan	565-0853
37	Minamino Cardiovascular Hospital	Hachioji	Tokyo	Japan	192-0918
38	Hiroshima City Hospital	Hiroshima		Japan	730-8518
39	Miyazaki Medical Association Hospital	Miyazaki		Japan	880-2102
40	Clinica Omega	Mexico City	Distrito Federal	Mexico	06700
41	Cardiolink Clin Trials	Monterrey	Nuevo León	Mexico	64060
42	Eukarya PharmaSite	Monterrey	Nuevo León	Mexico	64718
43	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León	Mexico	66460
44	Centro de Atención e Investigación Cardiovascular del Potosí	San Luis Potosí		Mexico	78200
45	VieCuri Medisch Centrum, locatie Venlo	Venlo	Limburg	Netherlands	5912 BL
46	Amsterdam UMC, locatie AMC	Amsterdam	Noord-Holland	Netherlands	1105 AZ
47	Meander Medisch Centrum	Amersfoort	Utrecht	Netherlands	3813 TZ

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