Phase 2
N=205
A Study of LY3561774 in Participants With Mixed Dyslipidemia
Dyslipidemias · Lipid Metabolism Disorders · Metabolic Diseases · Hyperlipoproteinemia
Bottom Line
View on ClinicalTrials.gov: NCT05256654 ↗Enrolled (actual)
205
Serious AEs
5.4%
Results posted
Mar 2025
Primary outcome: Primary: Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180 — -11.6; -14.1; -24.3; -19.0 Percent change — p=0.691
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY3561774 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180 |
-11.6; -14.1; -24.3; -19.0 | 0.691 |
| SECONDARY Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180 |
-3.2; -55.7; -70.8; -77.3 | <.001 sig |
| SECONDARY Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180 |
-8.7; -9.9; -24.0; -19.7 | 0.854 |
| SECONDARY Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180 |
4.3; -2.1; -12.8; -19.4 | 0.143 |
| SECONDARY Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180 |
-10.2; -19.8; -33.1; -31.5 | 0.068 |
| SECONDARY Percent Change From Baseline for Triglycerides at Day 180 |
-15.1; -45.9; -57.8; -59.7 | <.001 sig |
| SECONDARY Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) |
-17.0; -49.0; -61.9; -69.8 | <.001 sig |
| SECONDARY Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) |
-9.8; -13.5; -27.6; -27.3 | 0.506 |
| SECONDARY Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) |
1.5; -1.9; -7.3; -10.9 | 0.428 |
| SECONDARY Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) |
-12.7; -7.1; -21.0; -17.5 | 0.412 |
| SECONDARY Percent Change From Baseline for Apolipoprotein B (ApoB) |
-9.5; -19.2; -19.7; -19.4 | 0.101 |
| SECONDARY Percent Change From Baseline for Triglycerides |
-13.9; -38.3; -50.5; -52.5 | <.001 sig |
| SECONDARY Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774 |
6979; 25045; 61306 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05256654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.