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

18361

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.

2022-07-20

2024-03-04

2024-06-03

Active (not recruiting)

Early phase I

175

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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2024-05-28