A Study of LY3561774 in Participants With Mixed Dyslipidemia

NCT05256654 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 18361J3F-MC-EZCB2021-005407-13
• Study Type: interventional
• Target: 205
• Locations: 7 countries
• Sites: 41

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.

Conditions

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Hyperlipoproteinemia

Keywords

Triglycerides; LDL Cholesterol; Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline for Apolipoprotein B (ApoB) at 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.

  Baseline, Day 180

Secondary Outcomes (12)

• Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180

  Baseline, Day 180

• Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180

  Baseline, Day 180

• Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180

  Baseline, Day 180

• Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180

  Baseline, Day 180

• Percent Change From Baseline for Triglycerides at Day 180

  Baseline, Day 180

Study Arms (4)

LY3561774 100 mg

EXPERIMENTAL

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.

Drug: LY3561774

LY3561774 400 mg

EXPERIMENTAL

Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Drug: LY3561774

LY3561774 800 mg

EXPERIMENTAL

Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Drug: LY3561774

Placebo

PLACEBO COMPARATOR

Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.

Drug: Placebo

Interventions

LY3561774 DRUG

Administered SC

Also known as: Solbinsiran

LY3561774 100 mg; LY3561774 400 mg; LY3561774 800 mg

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (41)

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

NECCR PrimaCare Research

Fall River, Massachusetts, 02721, United States

Location

Premier Research

Trenton, New Jersey, 08611, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

Location

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, C1027AAP, Argentina

Location

Glenny Corp

Buenos Aires, Ciudad Aut, C1430CKE, Argentina

Location

CIPREC

CABA, Ciudad Aut, C1061AAS, Argentina

Location

Investigaciones Medicas Imoba Srl

Buenos Aires, Ciudad Autónoma de Buenos Aire, C11056ABF, Argentina

Location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, C1425AGC, Argentina

Location

Sanatorio San Martin

Venado Tuerto, Santa Fe Province, 2600, Argentina

Location

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

Location

Clínica Privada Velez Sarsfield

Córdoba, 5016, Argentina

Location

Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)

Córdoba, X5002HWE, Argentina

Location

Centro de Investigaciones Clinicas del Litoral

Santa Fe, S3000FWO, Argentina

Location

OCT Research ULC

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

North York Diagnostic and Cardiac Centre

North York, Ontario, M6B 3H7, Canada

Location

Ecogene-21

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Viacar Recherche Clinique

Greenfield Park, Quebec, J4V 2G8, Canada

Location

Clinique des Maladies Lipidiques de Québec

Québec, Quebec, G1V 4W2, Canada

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, 103-0028, Japan

Location

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

AMC Nishiumeda Clinic

Osaka, 530-0001, Japan

Location

Virgen Cardiovascular Research SC

Guadalajara, Jalisco, 44670, Mexico

Location

Cardiolink Clin Trials

Monterrey, Nuevo León, 64060, Mexico

Location

Unidad Médica para la Salud Integral

San Nicolás de los Garza, Nuevo León, 66465, Mexico

Location

Medical Care and Research SA de CV

Mérida, Yucatán, 97070, Mexico

Location

Investigacion En Salud Y Metabolismo Sc

Chihuahua City, 31217, Mexico

Location

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Kujawsko-p, 85-231, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej "Przychodnia z Sercem"

Grojec, Lesser Poland Voivodeship, 32-615, Poland

Location

Centrum Zdrowia Tuchów

Wierzchosławice, Lesser Poland Voivodeship, 33-122, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Ege Universitesi Hastanesi

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Necmettin Erbakan Meram Medical Fac.

Meram, Konya, 42080, Turkey (Türkiye)

Location

Akdeniz Universitesi Hastanesi

Antalya, 07070, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical School Internal Diseases Institute

Istanbul, 34096, Turkey (Türkiye)

Location

Kocaeli Üniversitesi

Kocaeli, 41380, Turkey (Türkiye)

Location

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location

Related Publications (1)

• Ray KK, Oru E, Rosenson RS, Jones J, Ma X, Walgren J, Haupt A, Verma S, Gaudet D, Nicholls SJ, Ruotolo G. Durability and efficacy of solbinsiran, a GalNAc-conjugated siRNA targeting ANGPTL3, in adults with mixed dyslipidaemia (PROLONG-ANG3): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2025 May 3;405(10489):1594-1607. doi: 10.1016/S0140-6736(25)00507-0. Epub 2025 Mar 31.

  PMID: 40179932 DERIVED

Related Links

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

MeSH Terms

Conditions

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Hyperlipoproteinemias

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Hyperlipidemias

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: February 25, 2022
• Study Start: July 20, 2022
• Primary Completion: March 4, 2024
• Study Completion: May 23, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

ME (5); PL (5); CA (5); AR (10); TU (6); US (6); JP (4)