Phase 1 N=51 Randomized Double-blind Basic Science

A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01618916 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs) — 4; 3; 5; 2 Participants

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)	4; 3; 5; 2; 3; 0	—
SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014	4.24; 4.82; 14.6; 17.9; 9.21; 6.64	—
SECONDARY PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])	1080; 2110; 3890; 8230; 2450; 2810	—
SECONDARY PK: Time of Maximum Concentration (Tmax) of LY3015014	4; 4; 4; 4; 5; 5	—
SECONDARY Percent Change From Baseline to Days 43, 57, and 127 in LDL-C	-49.76; -47.56; -45.20; -46.64; 0.16; -47.01	<0.001 sig

Summary

This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body will be evaluated. Participants will participate in the study for approximately 3 months not including screening. Screening is required within 42 days prior to the start of the study.

Eligibility Criteria

Inclusion Criteria

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

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 posttreatment hypersensitivity reactions [including but not limited to erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
Have significant history of or current cardiovascular, 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 (NCT01618916). 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.