A Study of LY3475766 in Healthy Participants

NCT04052594 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17394J1T-MC-GZEA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

This study will evaluate the safety and tolerability of LY3475766 when given to participants with high levels of blood fat called triglycerides. It will also investigate how the body processes the study drug and the effect of the study drug on the body. Information about any side effects will be documented. This study will last up to 16 weeks for each participant.

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 Day 85

Secondary Outcomes (6)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766

  Predose up to Day 85

• PK: Maximum Observed Drug Concentration (Cmax) of LY3475766

  Predose up to Day 85

• PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766

  Predose up to Day 85

• Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG)

  Baseline, Day 85

• PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

  Baseline, Day 85

Study Arms (4)

LY3475766 - IV

EXPERIMENTAL

LY3475766 administered intravenously (IV) to participants with dyslipidemia

Drug: LY3475766 - IV

Placebo - IV

PLACEBO COMPARATOR

Placebo administered IV to participants with dyslipidemia

Drug: Placebo - IV

LY3475766 - SC

EXPERIMENTAL

LY3475766 administered subcutaneously (SC) to participants with dyslipidemia

Drug: LY3475766 - SC

Placebo - SC

PLACEBO COMPARATOR

Placebo administered SC to participants with dyslipidemia

Drug: Placebo - SC

Interventions

LY3475766 - IV DRUG

Administered IV

LY3475766 - IV

LY3475766 - SC DRUG

Administered SC

LY3475766 - SC

Placebo - IV DRUG

Administered IV

Placebo - IV

Placebo - SC DRUG

Administered SC

Placebo - SC

Eligibility Criteria

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

You may qualify if:

• Are overtly healthy males or females, apart from dyslipidemia
• Male participants must agree to adhere to contraception restrictions
• Female participants must be of nonchildbearing potential and include those who are infertile due to surgical sterilization or those who are postmenopausal
• Have a body mass index (BMI) \>18.5 and \<40 kilograms per meter squared (kg/m²)
• Have clinical laboratory test results within normal reference range, or acceptable deviations per investigator discretion
• Have a fasting triglyceride (TG) level that is 135 to 499 milligrams per deciliter (mg/dL), inclusive, at both screening and Day -1
• Have a fasting low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL, inclusive, at screening and Day -1
• Have had a stable body weight for the 3 months prior to randomization (\<5% body weight change)
• Have not modified diet or adopted any nutritional lifestyle modification within 3 months prior to randomization

You may not qualify if:

• Are taking or have started taking Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 3 months prior to randomization; or statins, fibrates, or niacin ≤1000 mg/day within 8 weeks prior to randomization; or niacin \>1000 milligrams per day (mg/day) within 16 weeks prior to randomization; or any other lipid-lowering agents within 1 month prior to randomization
• Are taking or have started taking a beta-blocker, antiarrhythmic, non-dihydropyridine calcium channel blocker, ivabradine, or any other heart rate lowering agent within 1 month or 5 half-lives prior to randomization, whichever is longer
• Have a diagnosis of diabetes mellitus (type 1 diabetes mellitus or type 2 diabetes mellitus) or have 1 of the following at screening: fasting plasma glucose concentration ≥126 mg/dL (7.0 millimoles per liter \[mmol/L\]) OR a glycated hemoglobin level ≥6.5% (48 millimoles per mole \[mmol/mol\])
• Have previously completed or withdrawn from this study or any other study investigating LY3475766, and have previously received the investigational product
• Have known allergies to LY3475766, related compounds, or any components of the formulation, or history of significant atopy
• Have a seated heart rate ≤50 beats per minute
• Have clinically significant abnormal electrocardiogram (ECG) results constituting a risk while taking the investigational product, as determined by the investigator
• Have an abnormal blood pressure (BP) as determined by the investigator

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

WCCT Global

Cypress, California, 90630, United States

Location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

Covance Clinical Research Inc

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• Gaudet D, Gonciarz M, Shen X, Leohr JK, Beyer TP, Day JW, Mullins GR, Zhen EY, Hartley M, Larouche M, Konrad RJ, Benichou O, Ruotolo G. Targeting the angiopoietin-like protein 3/8 complex with a monoclonal antibody in patients with mixed hyperlipidemia: a phase 1 trial. Nat Med. 2025 Aug;31(8):2632-2639. doi: 10.1038/s41591-025-03830-4. Epub 2025 Jul 10.

  PMID: 40640392 DERIVED

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: August 8, 2019
• First Posted: August 12, 2019
• Study Start: September 3, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04-15

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)