A Study of LY3561774 in Participants With Mixed Dyslipidemia

• Status: Not yet recruiting
• Trial end date: 2023-11-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Have fasting non-HDLC-C ≥100 milligram/deciliter (mg/dL) 2.59 millimole/liter (mmol/L) and triglycerides within the range of 150 to 500 mg/dL (1.69 mmol/L to 5.65 mmol/L) at screening.

• Have fasting LDL-C >40 mg/dL (1.03 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, 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.