A Study of LY3561774 in Participants With Mixed Dyslipidemia

Study Overview
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Brief Summary
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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.

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

Conditions
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Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases, Hyperlipoproteinemia

Intervention / Treatment
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* Drug: LY3561774
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3561774 Dose 1<br>Participants will receive LY3561774 subcutaneously (SC) | Drug: LY3561774<br>* Administered SC<br>|
| Experimental: LY3561774 Dose 2<br>Participants will receive LY3561774 SC | Drug: LY3561774<br>* Administered SC<br>|
| Experimental: LY3561774 Dose 3<br>Participants will receive LY3561774 SC | Drug: LY3561774<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline for Apolipoprotein B (ApoB) |  | Baseline, Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline for Angiopoietin-like (ANGPTL3) |  | Baseline, Day 180 | 
| Percent Change from Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) |  | Baseline, Day 180 | 
| Percent Change from Baseline for High Density Lipoprotein-Cholesterol (HDL-C) |  | Baseline, Day 180 | 
| Percent Change from Baseline for Non-High-Density Lipoprotein-Cholesterol (non-HDL-C) |  | Baseline, Day 180 | 
| Percent Change from Baseline for Triglycerides |  | Baseline, Day 180 | 
| Percent Change from Baseline for ANGPTL3 |  | Baseline, Day 270 | 
| Percent Change from Baseline for non-HDL-C |  | Baseline, Day 270 | 
| Percent Change from Baseline for HDL-C |  | Baseline, Day 270 | 
| Percent Change from Baseline for LDL-C |  | Baseline, Day 270 | 
| Percent Change from Baseline for ApoB |  | Baseline, Day 270 | 
| Percent Change from Baseline for Triglycerides |  | Baseline, Day 270 | 
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3561774 |  | Up to Day 270 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triglycerides, LDL Cholesterol, Mixed Dyslipidemia