Clinical trial NCT05256654: A Study of LY3561774 in Participants With Mixed Dyslipidemia
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 in Adults With Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipoproteinemia
Keywords: Triglycerides
LDL Cholesterol
Mixed Dyslipidemia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-02-25
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180
timeFrame: Baseline, Day 180
Secondary outcomes:
measure: Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180
timeFrame: Baseline, Day 180
measure: Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180
timeFrame: Baseline, Day 180
measure: Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180
timeFrame: Baseline, Day 180
measure: Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180
timeFrame: Baseline, Day 180
measure: Percent Change From Baseline for Triglycerides at Day 180
timeFrame: Baseline, Day 180
measure: Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)
timeFrame: Baseline, Day 270
measure: Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
timeFrame: Baseline, Day 270
measure: Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline, Day 270
measure: Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline, Day 270
measure: Percent Change From Baseline for Apolipoprotein B (ApoB)
timeFrame: Baseline, Day 270
measure: Percent Change From Baseline for Triglycerides
timeFrame: Baseline, Day 270
measure: Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774
timeFrame: On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose
Other outcomes:
Locations:
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Air
city: Buenos Aires
country: Argentina
facility: Glenny Corp
state: Ciudad Aut
city: Caba
country: Argentina
facility: CIPREC
state: Ciudad Aut
city: Buenos Aires
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aire
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aire
city: Venado Tuerto
country: Argentina
facility: Sanatorio San Martin
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Córdoba
country: Argentina
facility: Clínica Privada Velez Sarsfield
city: Córdoba
country: Argentina
facility: Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones Clinicas del Litoral
city: Kelowna
country: Canada
facility: OCT Research ULC
state: British Columbia
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Greenfield Park
country: Canada
facility: Viacar Recherche Clinique
state: Quebec
city: Québec
country: Canada
facility: Clinique des Maladies Lipidiques de Québec
state: Quebec
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: Medical Corporation Chiseikai Tokyo Center Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic
state: Tokyo
city: Osaka
country: Japan
facility: AMC Nishiumeda Clinic
city: Guadalajara
country: Mexico
facility: Virgen Cardiovascular Research SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Cardiolink Clin Trials
state: Nuevo León
city: San Nicolás de los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral
state: Nuevo León
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
state: Kujawsko-p
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
state: Mazowieckie
city: Grojec
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej "Przychodnia z Sercem"
state: Małopolskie
city: Wierzchosławice
country: Poland
facility: Centrum Zdrowia Tuchów
state: Małopolskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi
state: İzmir
city: Meram
country: Turkey
facility: Necmettin Erbakan Meram Medical Fac.
state: Konya
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical School Internal Diseases Institute
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: