A Study of LY3561774 in Participants With Mixed Dyslipidemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases, Hyperlipoproteinemia

In brief

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.

Key facts

Study ID

NCT05256654

Run by

Eli Lilly and Company

People needed

205

Starts

2022-07-20

Expected to finish

2024-05-23

Last updated by the study team

2025-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• MD Medical Research — Oxon Hill, Maryland, United States
• NECCR PrimaCare Research — Fall River, Massachusetts, United States
• Premier Research — Trenton, New Jersey, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States
• Centro de Investigaciones Metabólicas (CINME) — Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
• Glenny Corp — Buenos Aires, Ciudad Aut, Argentina
• CIPREC — CABA, Ciudad Aut, Argentina
• Investigaciones Medicas Imoba Srl — Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina
• Sanatorio San Martin — Venado Tuerto, Santa Fe Province, Argentina
• Fundación Respirar — Buenos Aires, Argentina
• Clínica Privada Velez Sarsfield — Córdoba, Argentina
• Centro de Investigaciones Clinicas Instituto del Corazon (CICIC) — Córdoba, Argentina
• Centro de Investigaciones Clinicas del Litoral — Santa Fe, Argentina
• OCT Research ULC — Kelowna, British Columbia, Canada
• North York Diagnostic and Cardiac Centre — North York, Ontario, Canada
• Ecogene-21 — Chicoutimi, Quebec, Canada
• Viacar Recherche Clinique — Greenfield Park, Quebec, Canada
• Clinique des Maladies Lipidiques de Québec — Québec, Quebec, Canada
• Medical Corporation Heishinkai OCROM Clinic — Suita-shi, Osaka, Japan
• Medical Corporation Chiseikai Tokyo Center Clinic — Chuo-ku, Tokyo, Japan
• Heishinkai Medical Group ToCROM Clinic — Shinjuku-ku, Tokyo, Japan
• AMC Nishiumeda Clinic — Osaka, Japan

Full record on ClinicalTrials.gov

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