A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]

JRCT ID: jRCT2031220412

Registered date:26/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lipoprotein Disorder
• Date of first enrollment: 10/11/2022
• Target sample size: 254
• Countries of recruitment: Argentina,Japan,China,Japan,Denmark,Japan,Germany,Japan,Mexico,Japan,Netherlands,Japan,Romania,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: LY3819469
Administered SC
-Drug: Placebo
Administered SC

Study Arms
-Experimental: LY3819469 Dose 1
Participants will receive LY3819469 subcutaneously (SC).
Intervention: Drug: LY3819469
-Experimental: LY3819469 Dose 2
Participants will receive LY3819469 SC.
Intervention: Drug: LY3819469
-Experimental: LY3819469 Dose 3
Participants will receive LY3819469 SC.
Intervention: Drug: LY3819469
-Experimental: LY3819469 Dose 4 + Placebo
Participants will receive LY3819469 SC and placebo.
Interventions:
-Drug: LY3819469
-Drug: Placebo
-Placebo Comparator: Placebo
Participants will receive placebo.
Intervention: Drug: Placebo

Outcome(s)

• Primary Outcome: Percent Change from Baseline in Time Averaged Lipoprotein(a) [Lp(a)] [ Time Frame: Baseline, Days 60 - 180 ]

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participants must be at least 40 years old at the time of signing the informed consent.
-Participants with Lp(a) >=175 nmol/L at screening, measured at the central laboratory
-Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to screening and randomization and expected to remain on a stable regimen through the end of the Treatment and Assessment 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.
Male and/or Female
-Males who agree to use highly effective/effective methods of contraception may participate in this trial.
-Women not of childbearing potential (WNOCBP) may participate in this trial.

Exclude 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

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05565742