The trial is taking place at:
C

Chase Medical Research, LLC | Waterbury, MA

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

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Lilly

Status and phase

Active, not recruiting
Phase 2

Conditions

Metabolic Diseases
Lipid Metabolism Disorders
Dyslipidemias
Hyperlipoproteinemia

Treatments

Drug: LY3561774
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05256654
2021-005407-13 (EudraCT Number)
18361
J3F-MC-EZCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

175 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

175 participants in 4 patient groups, including a placebo group

LY3561774 Dose 1
Experimental group
Description:
Participants will receive LY3561774 subcutaneously (SC)
Treatment:
Drug: LY3561774
LY3561774 Dose 2
Experimental group
Description:
Participants will receive LY3561774 SC
Treatment:
Drug: LY3561774
LY3561774 Dose 3
Experimental group
Description:
Participants will receive LY3561774 SC
Treatment:
Drug: LY3561774
Placebo
Placebo Comparator group
Description:
Participants will receive placebo
Treatment:
Drug: Placebo

Trial contacts and locations

41

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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