Status:
COMPLETED
A Study of LY3561774 in Participants With Mixed Dyslipidemia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Dyslipidemias
Lipid Metabolism Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT05256654
Start Date
July 20 2022
End Date
May 23 2024
Last Update
March 17 2025
Active Locations (41)
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1
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
2
MD Medical Research
Oxon Hill, Maryland, United States, 20745
3
NECCR PrimaCare Research
Fall River, Massachusetts, United States, 02721
4
Premier Research
Trenton, New Jersey, United States, 08611