NCT01426412

Brief Summary

This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low density lipoprotein cholesterol (LDL-C). Following single 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 remain in the study for approximately up to 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

April 5, 2019

Completed
Last Updated

April 5, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

August 29, 2011

Results QC Date

January 7, 2019

Last Update Submit

January 7, 2019

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinically Significant Effects

    Adverse events (AEs) were considered as clinically significant effects. A summary of serious AEs (SAEs) and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events module.

    Baseline to study completion (up to 22 weeks)

Secondary Outcomes (4)

  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration of LY3015014 [AUC(0-tlast)]

    Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dose

  • PK: Maximum Concentration (Cmax) of LY3015014

    Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dose

  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

    Baseline, Days 15 and 29

  • Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies

    Days 8, 29 and 85

Study Arms (6)

LY3015014 intravenously (IV)

EXPERIMENTAL

A single dose of LY3015014 up to 10.0 milligrams per kilogram (mg/kg) administered IV

Drug: LY3015014 IV

LY3015014 IV Japanese

EXPERIMENTAL

Single dose of LY3015014 10.0 mg/kg administered IV to Japanese participants. Added per protocol amendment effective October, 2012.

Drug: LY3015014 IV

Placebo IV

PLACEBO COMPARATOR

Administered IV once only

Drug: Placebo IV

LY3015014 subcutaneously (SC)

EXPERIMENTAL

A single dose of LY3015014 up to 3.0 mg/kg administered SC

Drug: LY3015014 SC

LY3015014 SC + Statin

EXPERIMENTAL

A single dose of LY3015014 up to 3 mg/kg administered SC in addition to participant's dose of statin

Drug: LY3015014 SC

Placebo SC

PLACEBO COMPARATOR

Administered SC once only

Drug: Placebo SC

Interventions

LY3015014 IVDRUG

Administered IV over 30-90 minutes

LY3015014 IV JapaneseLY3015014 intravenously (IV)
Placebo IVDRUG

Administered IV only over 30-90 minutes

Placebo IV
LY3015014 SCDRUG

Administered SC

LY3015014 SC + StatinLY3015014 subcutaneously (SC)
Placebo SCDRUG

Administered SC

Placebo SC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • To qualify as Japanese for the purpose of this study, the participant must be first-generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan. Japanese participants have to be between the ages of 20-65, inclusive, at screening
  • Statin naive participants, have a screening LDL-C of between 100 and 180 milligrams per deciliter (mg/dL), inclusive; for participants currently taking a statin, have a screening LDL-C of between 100 and 160 mg/dL
  • Have serum triglycerides \<400 mg/dL
  • At screening, must have been on a stable dose of either atorvastatin \[10 to 40 mg once daily (QD)\], rosuvastatin (5 to 20 mg QD), simvastatin (20 to 40 mg QD), lovastatin (40 to 80 mg QD), or pravastatin (40 to 80 mg QD) which has been well tolerated for at least 3 months

You may not qualify if:

  • Have known allergies to compounds related to LY3015014 or any components of the formulation, or known clinically significant hypersensitivity to biologic agents, or known allergies to acetaminophen and/or antihistamines
  • Have received any vaccine(s) within 1 month of LY3015014 dosing, or intend to 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
  • Have a history of atopy, or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions \[including, but not limited to, erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis\]
  • Incidence of unexplained muscle pain, or incidence of frequent muscle cramp within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Glendale, California, 91206, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dallas, Texas, 75247, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2011

First Posted

August 31, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 5, 2019

Results First Posted

April 5, 2019

Record last verified: 2019-01

Locations

US(3)