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Completed

NCT Number: NCT04052594

A Study of LY3475766 in Healthy Participants

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.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global, Cypress, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

LY3475766 - IV

Drug

Administered IV

LY3475766 - SC

Drug

Administered SC

Placebo - IV

Drug

Administered IV

Placebo - SC

Drug

Administered SC

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

    Time frame: Baseline up to Day 85

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

Secondary outcomes

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

    Time frame: Predose up to Day 85

    PK: AUC of LY3475766

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

    Time frame: Predose up to Day 85

    PK: Cmax of LY3475766

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

    Time frame: Predose up to Day 85

    PK: Tmax of LY3475766

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

    Time frame: Baseline, Day 85

    PD: Percent Change from Baseline in TG

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

    Time frame: Baseline, Day 85

    PD: Percent Change from Baseline in LDL-C

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

    Time frame: Baseline, Day 85

    PD: Percent Change from Baseline in ApoB

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind, Single Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3475766

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2019
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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