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A Study of LY3561774 in Participants With Mixed Dyslipidemia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of LY3561774 in Participants With Mixed Dyslipidemia

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

NCT05256654•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+8 more criteria

Locations (41)

Chase Medical Research, LLC

Waterbury, Connecticut, United States

MD Medical Research

Oxon Hill, Maryland, United States

NECCR PrimaCare Research

Fall River, Massachusetts, United States

Premier Research

Trenton, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Preferred Primary Care Physicians

Uniontown, Pennsylvania, United States

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Glenny Corp

Buenos Aires, Ciudad Aut, Argentina

CIPREC

CABA, Ciudad Aut, Argentina

Investigaciones Medicas Imoba Srl

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

Key Dates

Start Date

July 20, 2022

Primary Completion Date

March 4, 2024

Completion Date

May 23, 2024

Last Updated

March 17, 2025

Enrollment

205

ACTUAL participants

Conditions

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesHyperlipoproteinemia

Interventions

LY3561774

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY3561774 in Participants With Mixed Dyslipidemia

Inclusion Criteria

Exclusion Criteria

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