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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05256654
Recruitment Status : Recruiting
First Posted : February 25, 2022
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 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 : July 20, 2022
Estimated Primary Completion Date : January 26, 2024
Estimated Study Completion Date : April 25, 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percent Change from Baseline for Apolipoprotein B (ApoB) [ Time Frame: Baseline, Day 180 ]

Secondary Outcome Measures :
  1. Percent Change from Baseline for Angiopoietin-like (ANGPTL3) [ Time Frame: Baseline, Day 180 ]
  2. Percent Change from Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) [ Time Frame: Baseline, Day 180 ]
  3. Percent Change from Baseline for High Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline, Day 180 ]
  4. Percent Change from Baseline for Non-High-Density Lipoprotein-Cholesterol (non-HDL-C) [ Time Frame: Baseline, Day 180 ]
  5. Percent Change from Baseline for Triglycerides [ Time Frame: Baseline, Day 180 ]
  6. Percent Change from Baseline for ANGPTL3 [ Time Frame: Baseline, Day 270 ]
  7. Percent Change from Baseline for non-HDL-C [ Time Frame: Baseline, Day 270 ]
  8. Percent Change from Baseline for HDL-C [ Time Frame: Baseline, Day 270 ]
  9. Percent Change from Baseline for LDL-C [ Time Frame: Baseline, Day 270 ]
  10. Percent Change from Baseline for ApoB [ Time Frame: Baseline, Day 270 ]
  11. Percent Change from Baseline for Triglycerides [ Time Frame: Baseline, Day 270 ]
  12. Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3561774 [ Time Frame: Up to Day 270 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05256654


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05256654    
Other Study ID Numbers: 18361
J3F-MC-EZCB ( Other Identifier: Eli Lilly and Company )
2021-005407-13 ( EudraCT Number )
First Posted: February 25, 2022    Key Record Dates
Last Update Posted: April 20, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Triglycerides
LDL Cholesterol
Mixed Dyslipidemia
Additional relevant MeSH terms:
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Dyslipidemias
Metabolic Diseases
Lipid Metabolism Disorders
Hyperlipoproteinemias
Hyperlipidemias