Lipoprotein DisorderPhase 2KRAKENNCT05563246

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

A Phase 2 study testing LY3473329 in people with Lipoprotein Disorder, run by Eli Lilly and Company at 42 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Lipoprotein Disorder
What is being tested?: LY3473329
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 233 participants
Where: 42 sitesin 8 countries
Study dates: 24 Nov 2022to 14 Mar 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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.

Who cannot join

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

Show all 9Show fewer

acute limb ischemia
Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes
Have uncontrolled hypertension

Trial locations and contacts

42 sites in 8 countries.

Country

City, postcode or hospital

42 sites in 8 countries

Brazil8 sites

Centro de Pesquisa Clinica do Coracao
Acaraju, Sergipe, 49055-530
Pesquisa Clínica em Diabetes - Dra Rosângela Réa
Curitiba, Paraná, 80040-110
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 22241-180
Incor - Instituto do Coracao
São Paulo, São Paulo, 05403-900
CPCLIN
São Paulo, 01228-200
Instituto Dante Pazzanese de Cardiology
São Paulo, 04012-909
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
CEDOES
Vitória, Espírito Santo, 29055450

Other trials in Brazil

China8 sites

China-Japan Union Hospital
Changchun, Jilin, 130033
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213000
The First Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330009
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Third People's Hospital of Hainan Province
Sanya, Hainan, 572000
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061

Other trials in China

Japan7 sites

Funabashi Municipal Medical Center
Funabashi, Chiba, 273-0853
Minamino Cardiovascular Hospital
Hachiōji, Tokyo, 192-0918
Hiroshima City Hospital
Hiroshima, 730-8518
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Miyazaki Medical Association Hospital
Miyazaki, 880-2102
Iwate Prefectural Central Hospital
Morioka, Iwate, 020-0066
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853

Other trials in Japan

Hungary6 sites

Dél-Pesti Centrumkórház
Budapest, 1097
Semmelweis University
Budapest, 1122
Flor Ferenc Hospital of Pest County
Kistarcsa, Pest County, 2143
Medifarma 98 Kft
Nyíregyháza, Nyíregyháza, 4400
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, 6720
Belvárosi Egészségház
Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Australia4 sites

Nightingale Research
Adelaide, South Australia, 5000
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Core Research Group
Brisbane, Queensland, 4064
Victorian Heart Hospital
Clayton, Victoria, 3168

Other trials in Australia

Germany4 sites

Private Practice - Dr. Frank Menzel
Dessau, 06846
Kath. St.-Johannes-Gesellschaft Dortmund
Dortmund, North Rhine-Westphalia, 44137
ClinPhenomics GmbH & Co KG
Frankfurt am Main, Hesse, 60596
Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte
Mühldorf, Bavaria, 84453

Other trials in Germany

United States3 sites

Care Access - Baltimore
Baltimore, Maryland, 21213
Care Access - Dorchester
Dorchester, Massachusetts, 02124
Care Access - Lima
Lima, Ohio, 45805

Other trials in United States

Netherlands2 sites

Meander Medisch Centrum
Amersfoort, Utrecht, 3813 TZ
VieCuri Medisch Centrum, locatie Venlo
Venlo, Limburg, 5912 BL

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About this study

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

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: Lipoprotein Disorder
Being tested: LY3473329, Placebo
Keywords: Atherosclerotic cardiovascular disease, ASCVD, Dyslipidemia, Lipoprotein(a), Lp(a), Cardiovascular, Cardiovascular disease, Cholesterol, Hyperlipidemia
Medical subject headings: Atherosclerosis, Dyslipidemias, Cardiovascular Diseases, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3473329Drug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT05563246
Study group	Role	What they receive
10 mg LY3473329	Experimental	Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period. Receives: Drug: LY3473329
60 mg LY3473329	Experimental	Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period. Receives: Drug: LY3473329
240 mg LY3473329	Experimental	Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period. Receives: Drug: LY3473329
Placebo	Placebo comparator	Participants received a matching dose of placebo administered orally QD over a 12-week treatment period. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay
Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time.
Measured: Baseline, Week 12
Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay
LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time.
Measured: Baseline, Week 12

Secondary outcomes (5)

Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay
The percentage of participants who achieved Lp(a) less than (<) 125 nmol/L, as measured using the intact Lp(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.
Measured: Week 12
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay
The percentage of participants who achieved Lp(a) < 125 nmol/L, as measured using the apo(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.
Measured: Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB)
LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment*Time.
Measured: Baseline, Week 12
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment*Time.
Measured: Baseline, Week 12
Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329
C-trough were measured at specified time points to assess the minimum concentration of LY3473329 in the blood before the next dose was administered.
Measured: Week from randomization 1, 2, 8, 12: Pre-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 202214 Mar 2024

First posted3 Oct 2022
Study start24 Nov 2022
Primary completion14 Mar 2024
Study completion14 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Lipoprotein DisorderStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05563246
Sponsor's protocol ID: 18495
Other IDs: J2O-MC-EKBC, 2022-501466-21-00
Acronym: KRAKEN
Status last verified: Mar 2025
First submitted: 28 Sep 2022
Last updated: 25 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Nicholls SJ, Ni W, Rhodes GM, Nissen SE, Navar AM, Michael LF, Haupt A, Krege JH. Oral Muvalaplin for Lowering of Lipoprotein(a): A Randomized Clinical Trial. JAMA. 2025 Jan 21;333(3):222-231. doi: 10.1001/jama.2024.24017.
PubMed 39556768
Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
PubMed 39329200
Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.
PubMed 38415744

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Hypercholesterolemia, Atherosclerosis
RecruitingPhase 3
A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk
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RecruitingPhase 1
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia
Healthy Participants, Dyslipidemia
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 2
Phase 2 Study of Kylo-11 in ASCVD Patients With Elevated Lp(a)
Lipoprotein Disorder

All Lipoprotein Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05563246
Acronym / sponsor ID: KRAKEN / 18495
Conditions: Lipoprotein Disorder
Keywords: Atherosclerotic cardiovascular disease, ASCVD, Dyslipidemia, Lipoprotein(a), Lp(a), Cardiovascular, Cardiovascular disease, Cholesterol
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 24 Nov 2022 (actual)
Primary completion: 14 Mar 2024 (actual)
Study completion: 14 Mar 2024 (actual)
First posted: 3 Oct 2022 (actual)
Results: Posted 25 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
10 mg LY3473329	Experimental	Drug: LY3473329Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period.
60 mg LY3473329	Experimental	Drug: LY3473329Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
240 mg LY3473329	Experimental	Drug: LY3473329Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
Placebo	Placebo comparator	Drug: PlaceboParticipants received a matching dose of placebo administered orally QD over a 12-week treatment period.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.
Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.

Key exclusion criteria (9 listed)

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:
Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes
Have uncontrolled hypertension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3473329Administered orally	Drug	10 mg LY3473329, 240 mg LY3473329, 60 mg LY3473329
PlaceboAdministered orally	Drug	Placebo

Primary outcome

Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay
Time frame: Baseline, Week 12
Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time.
Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay
Time frame: Baseline, Week 12
LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time.

5 secondary outcomes

Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay
Time frame: Week 12
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay
Time frame: Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB)
Time frame: Baseline, Week 12
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 12
Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329
Time frame: Week from randomization 1, 2, 8, 12: Pre-dose

Results and safety

Results posted to the registry on 25 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 mg LY3473329	34	33
60 mg LY3473329	64	60
240 mg LY3473329	68	65
Placebo	67	67

Primary outcome: Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: Percent change

Measure	10 mg LY3473329 n = 23	60 mg LY3473329 n = 45	240 mg LY3473329 n = 47	Placebo n = 49
Value	-47.35 (4.811)	-81.57 (1.230)	-85.71 (0.927)	0.48 (6.382)

10 mg LY3473329 vs Placebo: LS Mean Difference (Final Values): -47.61 (95% CI -57.68 to -35.14), p <.001, Mixed Models Analysis
60 mg LY3473329 vs Placebo: LS Mean Difference (Final Values): -81.66 (95% CI -84.62 to -78.13), p <.001, Mixed Models Analysis
240 mg LY3473329 vs Placebo: LS Mean Difference (Final Values): -85.77 (95% CI -88.03 to -83.09), p <.001, Mixed Models Analysis

Population analysed: All randomized participants who received at least one dose of the study drug had a non-missing baseline value and at least one post-baseline value, as assessed by the intact Lp(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.

Primary outcome: Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: Percent change

Measure	10 mg LY3473329 n = 29	60 mg LY3473329 n = 56	240 mg LY3473329 n = 57	Placebo n = 60
Value	-42.26 (4.477)	-70.90 (1.669)	-69.88 (1.676)	-3.15 (5.342)

10 mg LY3473329 vs Placebo: LS Mean Difference (Final Values): -40.38 (95% CI -50.45 to -28.27), p <.001, Mixed Models Analysis
60 mg LY3473329 vs Placebo: LS Mean Difference (Final Values): -69.95 (95% CI -74.23 to -64.96), p <.001, Mixed Models Analysis
240 mg LY3473329 vs Placebo: LS Mean Difference (Final Values): -68.90 (95% CI -73.27 to -63.81), p <.001, Mixed Models Analysis

Population analysed: All randomized participants who received at least one dose of the study drug, had a non-missing baseline value, and at least one post-baseline value, as assessed by the apo(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to end of follow-up (up to 16 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 mg LY3473329	2 of 34 (5.9%)	7 of 34 (20.6%)	0 of 34
60 mg LY3473329	2 of 63 (3.2%)	5 of 63 (7.9%)	0 of 63
240 mg LY3473329	2 of 68 (2.9%)	10 of 68 (14.7%)	0 of 68
Placebo	4 of 67 (6%)	11 of 67 (16.4%)	0 of 67

Limitations and caveats (from the sponsor): Due to country-specific restrictions on sample storage, measurements for the primary endpoint and key secondary endpoints involving Lp(a), as assessed by the intact Lp(a) assay, could not be obtained from participants at the Chinese sites. As a result, intact Lp(a) assay outcome data from these sites were not reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39556768Nicholls SJ, Ni W, Rhodes GM, Nissen SE, Navar AM, Michael LF, Haupt A, Krege JH. Oral Muvalaplin for Lowering of Lipoprotein(a): A Randomized Clinical Trial. JAMA. 2025 Jan 21;333(3):222-231. doi: 10.1001/jama.2024.24017.
Derived from this study: PubMed 39329200Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
Derived from this study: PubMed 38415744Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.
A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (KRAKEN)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Lipoprotein Disorder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

42 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3473329 in people with Lipoprotein Disorder, run by Eli Lilly and Company at 42 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Brazil, China, Japan, Hungary, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563246, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.