PROLONG-ANG3: A Study of LY3561774 in Participants With Mixed Dyslipidemia

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05256654

Collaborator

(none)

225

Enrollment

Locations

Arms

19.4

Anticipated Duration (Months)

5.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Hyperlipoproteinemia	Drug: LY3561774 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 20, 2022

Anticipated Primary Completion Date :

Sep 4, 2023

Anticipated Study Completion Date :

Mar 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3561774 Dose 1 Participants will receive LY3561774 subcutaneously (SC)	Drug: LY3561774 Administered SC
Experimental: LY3561774 Dose 2 Participants will receive LY3561774 SC	Drug: LY3561774 Administered SC
Experimental: LY3561774 Dose 3 Participants will receive LY3561774 SC	Drug: LY3561774 Administered SC
Placebo Comparator: Placebo Participants will receive placebo	Drug: Placebo Administered SC

Outcome Measures

Primary Outcome Measures

Percent Change from Baseline for Apolipoprotein B (ApoB) [Baseline, Day 180]

Secondary Outcome Measures

Percent Change from Baseline for Angiopoietin-like (ANGPTL3) [Baseline, Day 180]
Percent Change from Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) [Baseline, Day 180]
Percent Change from Baseline for High Density Lipoprotein-Cholesterol (HDL-C) [Baseline, Day 180]
Percent Change from Baseline for Non-High-Density Lipoprotein-Cholesterol (non-HDL-C) [Baseline, Day 180]
Percent Change from Baseline for Triglycerides [Baseline, Day 180]
Percent Change from Baseline for ANGPTL3 [Baseline, Day 270]
Percent Change from Baseline for non-HDL-C [Baseline, Day 270]
Percent Change from Baseline for HDL-C [Baseline, Day 270]
Percent Change from Baseline for LDL-C [Baseline, Day 270]
Percent Change from Baseline for ApoB [Baseline, Day 270]
Percent Change from Baseline for Triglycerides [Baseline, Day 270]
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3561774 [Up to Day 270]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have fasting triglycerides (TGs) within the range of 200 to 499 milligram/deciliter (mg/dL) 2.26 to 5.64 millimole/liter (mmol/L) at screening.
Have fasting LDL-C ≥100 mg/dL (2.59 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, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
2	MD Medical Research	Oxon Hill	Maryland	United States	20745
3	NECCR PrimaCare Research	Fall River	Massachusetts	United States	02721
4	Premier Research	Trenton	New Jersey	United States	08611
5	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
6	Preferred Primary Care Physicians	Uniontown	Pennsylvania	United States	15401
7	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires	Argentina	C1027AAP
8	Glenny Corp	Buenos Aires	Ciudad Autónoma De Buenos Aire	Argentina	1430
9	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aire	Argentina	C1061AAS
10	Investigaciones Medicas Imoba Srl	Buenos Aires	Ciudad Autónoma De Buenos Aire	Argentina	C1179AAB
11	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aire	Ciudad Autónoma De Buenos Aire	Argentina	C1425AGC
12	Sanatorio San Martin	Venado Tuerto	Santa Fe	Argentina	2600
13	Fundación Respirar	Buenos Aires		Argentina	C1426ABP
14	Clínica Privada Velez Sarsfield	Córdoba		Argentina	5016
15	Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)	Córdoba		Argentina	X5002HWE
16	Centro de Investigaciones Clinicas del Litoral	Santa Fe		Argentina	3000
17	OCT Research ULC	Kelowna	British Columbia	Canada	V1Y 1Z9
18	North York Diagnostic and Cardiac Centre	North York	Ontario	Canada	M6B 3H7
19	Ecogene-21	Chicoutimi	Quebec	Canada	G7H 7K9
20	Viacar Recherche Clinique	Greenfield Park	Quebec	Canada	J4V 2G8
21	Clinique des Maladies Lipidiques de Québec	Québec	Quebec	Canada	G1V 4W2
22	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka	Japan	565-0853
23	Medical Corporation Chiseikai Tokyo Center Clinic	Chuo-ku	Tokyo	Japan	103-0028
24	Heishinkai Medical Group ToCROM Clinic	Shinjuku-ku	Tokyo	Japan	160-0008
25	AMC Nishiumeda Clinic	Osaka		Japan	530-0001
26	Virgen Cardiovascular Research SC	Guadalajara	Jalisco	Mexico	44670
27	Cardiolink Clin Trials	Monterrey	Nuevo León	Mexico	64060
28	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Nuevo León	Mexico	66465
29	Medical Care and Research SA de CV	Merida	Yucatán	Mexico	97070
30	Investigacion En Salud Y Metabolismo Sc	Chihuahua		Mexico	31217
31	NZOZ Centrum Medyczne KERmed	Bydgoszcz	Kujawsko-pomorskie	Poland	85-231
32	Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie	Warsaw	Mazowieckie	Poland	02-097
33	Niepubliczny Zakład Opieki Zdrowotnej "Przychodnia z Sercem"	Grojec	Małopolskie	Poland	32-615
34	Centrum Zdrowia Tuchów	Wierzchosławice	Małopolskie	Poland	33-122
35	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie	Poland	80-546
36	Ege University Medicine of Faculty	Bornova	İzmir	Turkey	35100
37	Necmettin Erbakan Meram Medical Fac.	Meram	Konya	Turkey	42080
38	Akdeniz Universitesi Hastanesi	Antalya		Turkey	07070
39	Istanbul University Cerrahpasa Medical School Internal Diseases Institute	Istanbul		Turkey	34098
40	Kocaeli Üniversitesi	Kocaeli		Turkey	41380
41	Mersin University	Mersin		Turkey	33343

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company