A Study of LY3561774 in Participants With Mixed Dyslipidemia (PROLONG-ANG3)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 in Adults With Mixed Dyslipidemia

This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.

Inclusion Criteria: Have fasting triglycerides (TGs) within the range of 150 (1.69 millimole/liter (mmoL) to 499 milligram/deciliter (mg/dL) 2.26 to 5.64 millimole/liter (mmol/L) at screening. Have fasting LDL-C ≥70 mg/dL (1.81 mmol/L) at screening. Have non-HDL-C ≥ 130 mg/dL (3.36 mmol/L) at screening. Must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study. Have a body mass index within the range of 18.5 to 40.0 kilogram/square meter (kg/m²), inclusive Exclusion Criteria: Have in the 6 months prior to screening, uncontrolled Type 1 or Type 2 diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization, or have an hemoglobin A1c (HbA1c) ≥8% at screening. Have a history of nephrotic syndrome. Have a history of acute or chronic pancreatitis. Have had within the past 3 months prior to screening Myocardial infarction Unstable angina Coronary artery bypass graft Percutaneous coronary intervention - diagnostic angiograms are permitted Peripheral artery disease Transient ischemic attack, or Cerebrovascular accident Have New York Heart Association Class III or IV heart failure or last known left ventricular ejection fraction <30%. Have undergone LDL apheresis within 12 months prior to screening. Have clinically relevant anemia, as defined by the investigator. Have, within 1 year prior to screening or plan on having during the study, surgical treatment for obesity. Have within 3 years prior to screening a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse. Have uncontrolled hypertension. Have used or are taking products for the purpose of lowering lipid levels (except for statins, PCSK9 inhibitors, bempedoic acid, and ezetimibe). This includes lipid-regulating medication, over-the-counter products, or herbal therapies.

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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.

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.

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.