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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05563246




Registration number
NCT05563246
Ethics application status
Date submitted
28/09/2022
Date registered
3/10/2022

Titles & IDs
Public title
A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
Scientific 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
Secondary ID [1] 0 0
J2O-MC-EKBC
Secondary ID [2] 0 0
18495
Universal Trial Number (UTN)
Trial acronym
KRAKEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lipoprotein Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3473329
Treatment: Drugs - Placebo

Experimental: LY3473329 Dose 1 - Participants will receive LY3473329 orally.

Experimental: LY3473329 Dose 2 - Participants will receive LY3473329 orally.

Experimental: LY3473329 Dose 3 - Participants will receive LY3473329 orally.

Placebo comparator: Placebo - Participants will receive placebo orally.


Treatment: Drugs: LY3473329
Administered orally

Treatment: Drugs: Placebo
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change from Baseline in Lipoprotein (a) Lp(a)
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Lp(a) <125 Nanomole/Liter (nmol/L)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percent Change from Baseline for Apolipoprotein B (ApoB)
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Percent Change from Baseline for High Sensitivity C-reactive (hsCRP)
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3473329
Timepoint [4] 0 0
Baseline to Week 12

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/03/2024
Sample size
Target
Accrual to date
Final
233
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Core Research Group - Brisbane
Recruitment hospital [2] 0 0
Nightingale Research - Adelaide
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 0 0
4064 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
Brazil
State/province [4] 0 0
Espírito Santo
Country [5] 0 0
Brazil
State/province [5] 0 0
Paraná
Country [6] 0 0
Brazil
State/province [6] 0 0
Sergipe
Country [7] 0 0
Brazil
State/province [7] 0 0
São Paulo
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio de Janeiro
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
China
State/province [10] 0 0
Hainan
Country [11] 0 0
China
State/province [11] 0 0
Heilongjiang
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
China
State/province [13] 0 0
Jiangxi
Country [14] 0 0
China
State/province [14] 0 0
Jilin
Country [15] 0 0
China
State/province [15] 0 0
Shaanxi
Country [16] 0 0
Germany
State/province [16] 0 0
Bayern
Country [17] 0 0
Germany
State/province [17] 0 0
Hessen
Country [18] 0 0
Germany
State/province [18] 0 0
Nordrhein-Westfalen
Country [19] 0 0
Germany
State/province [19] 0 0
Dessau
Country [20] 0 0
Hungary
State/province [20] 0 0
Csongrád
Country [21] 0 0
Hungary
State/province [21] 0 0
Nyíregyháza
Country [22] 0 0
Hungary
State/province [22] 0 0
Pest
Country [23] 0 0
Hungary
State/province [23] 0 0
Zala
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Japan
State/province [25] 0 0
Chiba
Country [26] 0 0
Japan
State/province [26] 0 0
Fukuoka
Country [27] 0 0
Japan
State/province [27] 0 0
Iwate
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Japan
State/province [30] 0 0
Hiroshima
Country [31] 0 0
Japan
State/province [31] 0 0
Miyazaki
Country [32] 0 0
Netherlands
State/province [32] 0 0
Limburg
Country [33] 0 0
Netherlands
State/province [33] 0 0
Utrecht

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05563246