A Study of LY3015014 in Healthy Participants With High Cholesterol

NCT01671085 | Completed Phase 1 Results

• 2 other identifiers: 14938I5S-EW-EFJD
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)

  Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

  Baseline through study completion (Day 127)

Secondary Outcomes (4)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014

  Day 1 and 29: 4 hours (h) and 24 h postdose

• PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014

  Day 1 and 29: 4 h and 24 h postdose

• PK: Time of Maximum Concentration (Tmax) of LY3015014

  Day 1 and 29: 4 h and 24 h postdose

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

  Baseline, Day 43 and Day 57

Study Arms (2)

1.0 milligrams per kilogram (mg/kg) of LY3015014

EXPERIMENTAL

1.0 mg/kg of LY3015014 given subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).

Drug: LY3015014

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride injection given SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).

Drug: Placebo

Interventions

LY3015014 DRUG

Administered SQ

1.0 milligrams per kilogram (mg/kg) of LY3015014

Placebo DRUG

Administered SQ

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Miramar, Florida, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

frovocimab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 15, 2019
• Results First Posted: February 25, 2019

Record last verified: 2019-02

Locations

US (1)