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

Lilly

Status and phase: Active, not recruiting; Phase 2

Conditions: Lipoprotein Disorder

Treatments: Drug: Placebo; Drug: LY3819469

Study type: Interventional

Funder types: Industry

Identifiers

NCT05565742

18547

J3L-MC-EZEB (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.

Enrollment: 216 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 5 patient groups, including a placebo group

LY3819469 Dose 1

Experimental group

Description:

Participants will receive LY3819469 subcutaneously (SC).

Treatment:

Drug: LY3819469

LY3819469 Dose 2

Experimental group

Description:

Participants will receive LY3819469 SC.

Treatment:

Drug: LY3819469

LY3819469 Dose 3

Experimental group

Description:

Participants will receive LY3819469 SC.

Treatment:

Drug: LY3819469

LY3819469 Dose 4 + Placebo

Experimental group

Description:

Participants will receive LY3819469 SC and placebo.

Treatment:

Drug: LY3819469

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo