A Study of LY3561774 in Participants With Mixed Dyslipidemia

JRCT ID: jRCT2031220033

Registered date:23/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dyslipidemias,Lipid Metabolism Disorders,Metabolic Diseases,Hyperlipoproteinemia
• Date of first enrollment: 02/06/2022
• Target sample size: 225
• Countries of recruitment: Argentina,Japan,Canada,Japan,Mexico,Japan,Poland,Japan,Turkey,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: LY3561774
Administered SC
-Drug: Placebo
Administered SC
Study Arms
-Experimental: LY3561774 Dose 1
Participants will receive LY3561774 subcutaneously (SC)
Intervention: Drug: LY3561774
-Experimental: LY3561774 Dose 2
Participants will receive LY3561774 SC
Intervention: Drug: LY3561774
-Experimental: LY3561774 Dose 3
Participants will receive LY3561774 SC
Intervention: Drug: LY3561774
-Experimental: LY3561774 Dose 4
Participants will receive LY3561774 SC
Intervention: Drug: LY3561774
-Placebo Comparator: Placebo
Participants will receive placebo
Intervention: Drug: Placebo

Outcome(s)

• Primary Outcome: Percent Change from Baseline for Non-High Density Lipoprotein-Cholesterol (non-HDL-C) [ Time Frame: Baseline, Day 180 ]

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05256654