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CompletedNCT04052594Updated Apr 28, 2021

A Study of LY3475766 in Healthy Participants

A Phase 1 interventional study of LY3475766 - IV and LY3475766 - SC in Dyslipidemias, sponsored by Eli Lilly and Company. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Mar 2021, 5 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dyslipidemias

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03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 48 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    LY3475766 - IV

    LY3475766 administered intravenously (IV) to participants with dyslipidemia

    Drug: LY3475766 - IV

  • Placebo comparator
    Placebo - IV

    Placebo administered IV to participants with dyslipidemia

    Drug: Placebo - IV

  • Experimental
    LY3475766 - SC

    LY3475766 administered subcutaneously (SC) to participants with dyslipidemia

    Drug: LY3475766 - SC

  • Placebo comparator
    Placebo - SC

    Placebo administered SC to participants with dyslipidemia

    Drug: Placebo - SC

Interventions

  • DrugLY3475766 - IV

    Administered IV

  • DrugLY3475766 - SC

    Administered SC

  • DrugPlacebo - IV

    Administered IV

  • DrugPlacebo - SC

    Administered SC

06

What researchers measure

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

    Time frame: Baseline up to Day 85

Secondary outcomes

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

    PK: AUC of LY3475766

    Time frame: Predose up to Day 85

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3475766

    PK: Cmax of LY3475766

    Time frame: Predose up to Day 85

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

    PK: Tmax of LY3475766

    Time frame: Predose up to Day 85

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

    PD: Percent Change from Baseline in TG

    Time frame: Baseline, Day 85

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

    PD: Percent Change from Baseline in LDL-C

    Time frame: Baseline, Day 85

  6. PD: Percent Change from Baseline in Apolipoprotein B (ApoB)

    PD: Percent Change from Baseline in ApoB

    Time frame: Baseline, Day 85

07

Study locations

4 sites
  • WCCT Global
    Cypress, California 90630, United States
  • Covance Clinical Research Inc
    Daytona Beach, Florida 32117, United States
  • Covance Dallas
    Dallas, Texas 75247, United States
  • Covance Clinical Research Inc
    Madison, Wisconsin 53704, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04052594
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 12, 2019
Start date
Sep 3, 2019
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
Apr 28, 2021

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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