A Study of LY3561774 in Participants With Dyslipidemia

NCT04644809 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17825J3F-MC-EZCA
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 5

Brief Summary

This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline up to Week 53

Secondary Outcomes (4)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774

  Predose through Day 8

• PK: Maximum Observed Drug Concentration (Cmax) of LY3561774

  Predose through Day 8

• PK: Time of Maximum Observed Concentration (Tmax) of LY3561774

  Predose through Day 8

• PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)

  Predose through Week 53

Study Arms (4)

LY3561774 (Part A)

EXPERIMENTAL

Single ascending doses of LY3561774 administered subcutaneously (SC).

Drug: LY3561774

LY3561774 (Part B)

EXPERIMENTAL

Repeat doses of LY3561774 administered SC.

Drug: LY3561774

LY3561774 (Part C)

EXPERIMENTAL

Single doses of LY3561774 administered SC in Japanese Participants.

Drug: LY3561774

Placebo (Part A, B & C)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3561774 DRUG

Administered SC.

LY3561774 (Part A); LY3561774 (Part B); LY3561774 (Part C)

Placebo DRUG

Administered SC.

Placebo (Part A, B & C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Parts A and B, have a fasting triglyceride (TG) level greater than or equal to (≥) 150 milligram/deciliter (mg/dL) and less than 500 mg/dL, as well as low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL
• For Part C, participants should be first-generation Japanese origin.
• Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
• Male participants must agree to adhere to contraception restrictions and female participants must not be able to get pregnant

You may not qualify if:

• Have taken any prescription medications that are for lowering serum TGs within the past 2 months (use of statins is allowed if the dose has been stable for 8 weeks)
• Have Type 1 diabetes
• Are currently participating in or completed a clinical trial within the last 30 days
• Are heavy alcohol drinkers or heavy cigarette smokers
• Have donated blood of more than 500 millilitres (mL) in the last 3 months

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Location

Collaborative Neuroscience Research, LLC

Long Beach, California, 90806, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• Ray KK, Linnebjerg H, Michael LF, Shen X, Ma X, Lim S, Zhen EY, Dudek H, Abrams M, Saxena U, Turanov A, Nicholls SJ, Ruotolo G. Effect of ANGPTL3 Inhibition With Solbinsiran in Preclinical and Early Human Studies. J Am Coll Cardiol. 2025 May 20;85(19):1803-1818. doi: 10.1016/j.jacc.2025.03.005. Epub 2025 Mar 30.

  PMID: 40158211 DERIVED

Related Links

• A Study of LY3561774 in Participants With Dyslipidemia

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: November 25, 2020
• Study Start: November 30, 2020
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)