A Study of LY3561774 in Participants With Mixed Dyslipidemia

Phase 2

Completed

Conditions: Dyslipidemias
Lipid Metabolism Disorders
Hyperlipoproteinemia
Metabolic Diseases

Interventions: Drug: LY3561774
Drug: Placebo

Registration Number: NCT05256654

Lead Sponsor: Eli Lilly and Company

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 with mixed dyslipidemia and on a stable dose of a statin.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 205

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3561774 100 mg	LY3561774	Participants received 100 milligram (mg) LY3561774 subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
LY3561774 400 mg	LY3561774	Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
LY3561774 800 mg	LY3561774	Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
Placebo	Placebo	Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180	Baseline, Day 180	Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180	Baseline, Day 180	Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180	Baseline, Day 180	Change in LDL-C levels from baseline to the day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180	Baseline, Day 180	Change in HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180	Baseline, Day 180	Change in non-HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for Triglycerides at Day 180	Baseline, Day 180	Change in triglycerides levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)	Baseline, Day 270	Change in ANGPTL3 levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)	Baseline, Day 270	Change in non-HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)	Baseline, Day 270	Change in HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)	Baseline, Day 270	Change in LDL-C levels from baseline to the day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Percent Change From Baseline for Apolipoprotein B (ApoB)	Baseline, Day 270	Change in apoB levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS mean using MMRM model adjusted for baseline.
Percent Change From Baseline for Triglycerides	Baseline, Day 270	Change in triglycerides levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774	On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose	PK: Seady State AUC (0-∞) of LY3561774

Trial Locations

Locations (41): Unidad Médica para la Salud Integral
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San Nicolás de los Garza, Nuevo León, Mexico
Niepubliczny Zakład Opieki Zdrowotnej "Przychodnia z Sercem"
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Grojec, Małopolskie, Poland
North York Diagnostic and Cardiac Centre
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North York, Ontario, Canada
CIPREC
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Caba, Ciudad Aut, Argentina
Investigaciones Medicas Imoba Srl
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Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Investigacion En Salud Y Metabolismo Sc
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Chihuahua, Mexico
Sanatorio San Martin
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Venado Tuerto, Santa Fe, Argentina
NZOZ Centrum Medyczne KERmed
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Bydgoszcz, Kujawsko-p, Poland
Glenny Corp
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Buenos Aires, Ciudad Aut, Argentina
NECCR PrimaCare Research
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Fall River, Massachusetts, United States
Ecogene-21
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Chicoutimi, Quebec, Canada
Clínica Privada Velez Sarsfield
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Córdoba, Argentina
Centrum Zdrowia Tuchów
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Wierzchosławice, Małopolskie, Poland
Viacar Recherche Clinique
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Greenfield Park, Quebec, Canada
Heishinkai Medical Group ToCROM Clinic
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Shinjuku-ku, Tokyo, Japan
Medical Corporation Chiseikai Tokyo Center Clinic
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Chuo-ku, Tokyo, Japan
Cardiolink Clin Trials
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Monterrey, Nuevo León, Mexico
Akdeniz Universitesi Hastanesi
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Antalya, Turkey
Kocaeli Üniversitesi
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Kocaeli, Turkey
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
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Warsaw, Mazowieckie, Poland
Istanbul University Cerrahpasa Medical School Internal Diseases Institute
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Istanbul, Turkey
AMC Nishiumeda Clinic
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Osaka, Japan
Ege Universitesi Hastanesi
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Bornova, İzmir, Turkey
Medical Care and Research SA de CV
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Merida, Yucatán, Mexico
Icahn School of Medicine at Mount Sinai
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New York, New York, United States
Mersin University
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Mersin, Turkey
Preferred Primary Care Physicians
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Uniontown, Pennsylvania, United States
Premier Research
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Trenton, New Jersey, United States
Chase Medical Research, LLC
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Waterbury, Connecticut, United States
MD Medical Research
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Oxon Hill, Maryland, United States
Centro de Investigaciones Metabólicas (CINME)
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Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Centro de Investigaciones Clinicas del Litoral
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Santa Fe, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, Argentina
Fundación Respirar
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Buenos Aires, Argentina
Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)
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Córdoba, Argentina
Clinique des Maladies Lipidiques de Québec
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Québec, Quebec, Canada
Medical Corporation Heishinkai OCROM Clinic
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Suita-shi, Osaka, Japan
Virgen Cardiovascular Research SC
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Guadalajara, Jalisco, Mexico
Centrum Badan Klinicznych PI-House sp. z o.o.
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Gdansk, Pomorskie, Poland
Necmettin Erbakan Meram Medical Fac.
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Meram, Konya, Turkey
OCT Research ULC
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Kelowna, British Columbia, Canada