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

April 17, 2024 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Fundacion Respirar
      • Córdoba, Argentina, X5002HWE
        • Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)
      • Córdoba, Argentina, 5016
        • Clinica Privada Velez Sarsfield
      • Santa Fe, Argentina, S3000FWO
        • Centro de Investigaciones Clinicas del Litoral
    • Buenos Air
      • Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (CINME)
    • Ciudad Aut
      • Buenos Aires, Ciudad Aut, Argentina, C1430CKE
        • Glenny Corp
      • Caba, Ciudad Aut, Argentina, C1061AAS
        • CIPREC
    • Ciudad Autónoma De Buenos Aire
      • Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1179AAB
        • Investigaciones Medicas Imoba Srl
      • Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
    • Santa Fe
      • Venado Tuerto, Santa Fe, Argentina, 2600
        • Sanatorio San Martin
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • OCT Research ULC
    • Ontario
      • North York, Ontario, Canada, M6B 3H7
        • North York Diagnostic and Cardiac Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Greenfield Park, Quebec, Canada, J4V 2G8
        • Viacar Recherche Clinique
      • Québec, Quebec, Canada, G1V 4W2
        • Clinique des Maladies Lipidiques de Québec
  • Japan
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 103-0028
        • Medical Corporation Chiseikai Tokyo Center Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Heishinkai Medical Group ToCROM Clinic
  • Mexico
      • Chihuahua, Mexico, 31217
        • Investigacion En Salud Y Metabolismo Sc
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Virgen Cardiovascular Research SC
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64060
        • Cardiolink Clin Trials
      • San Nicolás de los Garza, Nuevo León, Mexico, 66465
        • Unidad Médica para la Salud Integral
    • Yucatán
      • Merida, Yucatán, Mexico, 97070
        • Medical Care and Research SA de CV
  • Poland
    • Kujawsko-p
      • Bydgoszcz, Kujawsko-p, Poland, 85-231
        • NZOZ Centrum Medyczne KERmed
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-097
        • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
    • Małopolskie
      • Grojec, Małopolskie, Poland, 32-615
        • Niepubliczny Zakład Opieki Zdrowotnej "Przychodnia z Sercem"
      • Wierzchosławice, Małopolskie, Poland, 33-122
        • Centrum Zdrowia Tuchow
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badań Klinicznych PI-House sp. z o.o.
  • Turkey
      • Antalya, Turkey, 07070
        • Akdeniz Universitesi Hastanesi
      • Istanbul, Turkey, 34096
        • Istanbul University Cerrahpasa Medical School Internal Diseases Institute
      • Kocaeli, Turkey, 41380
        • Kocaeli Üniversitesi
      • Mersin, Turkey, 33343
        • Mersin University
    • Konya
      • Meram, Konya, Turkey, 42080
        • Necmettin Erbakan Meram Medical Fac.
    • İzmir
      • Bornova, İzmir, Turkey, 35100
        • Ege Universitesi Hastanesi
  • United States
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • MD Medical Research
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline for Apolipoprotein B (ApoB)
Time Frame: Baseline, Day 180
Baseline, Day 180

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Actual)

March 4, 2024

Study Completion (Estimated)

June 3, 2024

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18361
  • J3F-MC-EZCB (Other Identifier: Eli Lilly and Company)
  • 2021-005407-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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