A Study of LY3561774 in Participants With Mixed Dyslipidemia

Dyslipidemias Clinical Trial

— PROLONG-ANG3  

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 in Adults With Mixed Dyslipidemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05256654
• Other study ID #: 18361
• Secondary ID: J3F-MC-EZCB2021-
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 20, 2022
• Est. completion date: June 3, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: June 3, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemias
• Hyperlipoproteinemia
• Hyperlipoproteinemias
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• LY3561774
Administered SC
• Placebo
Administered SC

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Japan,  Mexico,  Poland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline for Apolipoprotein B (ApoB)		Baseline, Day 180
Secondary	Percent Change from Baseline for Angiopoietin-like (ANGPTL3)		Baseline, Day 180
Secondary	Percent Change from Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)		Baseline, Day 180
Secondary	Percent Change from Baseline for High Density Lipoprotein-Cholesterol (HDL-C)		Baseline, Day 180
Secondary	Percent Change from Baseline for Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)		Baseline, Day 180
Secondary	Percent Change from Baseline for Triglycerides		Baseline, Day 180
Secondary	Percent Change from Baseline for ANGPTL3		Baseline, Day 270
Secondary	Percent Change from Baseline for non-HDL-C		Baseline, Day 270
Secondary	Percent Change from Baseline for HDL-C		Baseline, Day 270
Secondary	Percent Change from Baseline for LDL-C		Baseline, Day 270
Secondary	Percent Change from Baseline for ApoB		Baseline, Day 270
Secondary	Percent Change from Baseline for Triglycerides		Baseline, Day 270
Secondary	Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3561774		Up to Day 270

External Links

•   A Study of LY3561774 in Participants With Mixed Dyslipidemia (PROLONG-ANG3)