Phase 1 N=13 Randomized Double-blind Basic Science

A Study of LY3015014 in Healthy Participants With High Cholesterol

Healthy Volunteers · Hypercholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT01671085 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs) — 3; 1; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: LY3015014 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)	3; 1; 0; 0	—
SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014	5.06; 5.57	—
SECONDARY PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014	1960; 2150	—
SECONDARY PK: Time of Maximum Concentration (Tmax) of LY3015014	4; 5	—
SECONDARY Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)	-49.10; 1.38; -37.53; 7.58	<0.001 sig

Summary

This is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins. Following multiple doses of LY3015014, investigators will study the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body. Participants will remain in the study for about 3 months, not including screening. Screening is required within 28 days before the study starts.

Eligibility Criteria

Inclusion Criteria

Participants must be healthy males or females without childbearing potential as determined by medical history and physical examination
Have body mass indexes of 18 to 35 kilograms per square meter (kg/m^2), inclusive, at screening
Have screening low density lipoprotein-C (LDL-C) of between 100 and 180 milligrams per deciliter (mg/dL), inclusive, while having taken a stable dose of statin

Exclusion Criteria

Have known allergies to compounds related to LY3015014 or any components of the formulation or known clinically significant hypersensitivity to biologic agents
Have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions [including but not limited to erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis]
Have significant history of or current cardiovascular (excluding controlled hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of data
Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so during the study
Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01671085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.