Clinical trial NCT04052594: A Study of LY3475766 in Healthy Participants
Official title: A Randomized, Double-Blind, Single Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3475766
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemias
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-08-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Day 85
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766
timeFrame: Predose up to Day 85
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3475766
timeFrame: Predose up to Day 85
measure: PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766
timeFrame: Predose up to Day 85
measure: Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG)
timeFrame: Baseline, Day 85
measure: PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline, Day 85
measure: PD: Percent Change from Baseline in Apolipoprotein B (ApoB)
timeFrame: Baseline, Day 85
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global
state: California
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
city: Dallas
country: United States
facility: Covance Dallas
state: Texas
city: Madison
country: United States
facility: Covance Clinical Research Inc
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: