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OpenTrials
Completed

NCT Number: NCT05256654

A Study of LY3561774 in Participants 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3561774

Drug

Administered SC

Other names: Solbinsiran

Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, Day 180

    Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

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

    Time frame: Baseline, Day 180

    Change in LDL-C levels from baseline to the day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

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

    Time frame: Baseline, Day 180

    Change in HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

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

    Time frame: Baseline, Day 180

    Change in non-HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

  5. Percent Change From Baseline for Triglycerides at Day 180

    Time frame: Baseline, Day 180

    Change in triglycerides levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

  6. Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)

    Time frame: Baseline, Day 270

    Change in ANGPTL3 levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

  7. Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)

    Time frame: Baseline, Day 270

    Change in non-HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

  8. Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)

    Time frame: Baseline, Day 270

    Change in HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

  9. Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)

    Time frame: Baseline, Day 270

    Change in LDL-C levels from baseline to the day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

  10. Percent Change From Baseline for Apolipoprotein B (ApoB)

    Time frame: Baseline, Day 270

    Change in apoB levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS mean using MMRM model adjusted for baseline.

  11. Percent Change From Baseline for Triglycerides

    Time frame: Baseline, Day 270

    Change in triglycerides levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.

  12. Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774

    Time frame: On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose

    PK: Seady State AUC (0-∞) of LY3561774

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: PROLONG-ANG3

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2022
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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