A Study of LY3561774 in Participants With Mixed Dyslipidemia (NCT05256654) | Clinical Trial Compass
CompletedPhase 2
A Study of LY3561774 in Participants With Mixed Dyslipidemia
United States205 participantsStarted 2022-07-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180