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A Study of LY3475766 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052594
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : August 12, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: LY3475766 - IV Drug: LY3475766 - SC Drug: Placebo - IV Drug: Placebo - SC Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Single Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3475766
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : November 2, 2020
Estimated Study Completion Date : November 2, 2020

Arm Intervention/treatment
Experimental: LY3475766 - IV
LY3475766 administered intravenously (IV) to participants with dyslipidemia
Drug: LY3475766 - IV
Administered IV

Placebo Comparator: Placebo - IV
Placebo administered IV to participants with dyslipidemia
Drug: Placebo - IV
Administered IV

Experimental: LY3475766 - SC
LY3475766 administered subcutaneously (SC) to participants with dyslipidemia
Drug: LY3475766 - SC
Administered SC

Placebo Comparator: Placebo - SC
Placebo administered SC to participants with dyslipidemia
Drug: Placebo - SC
Administered SC




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052594


Locations
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United States, California
WCCT Global
Cypress, California, United States, 90630
United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
United States, Texas
Covance
Dallas, Texas, United States, 75247
United States, Wisconsin
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04052594    
Other Study ID Numbers: 17394
J1T-MC-GZEA ( Other Identifier: Eli Lilly and Company )
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases