CompletedNCT02242903Updated Oct 4, 2018Results posted

A Study of LY3079514 in Healthy Participants

A Phase 1 interventional study of LY3079514 and LY3079514 in Healthy Volunteers, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-04.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of study drug, LY3079514. This study will last about 12 weeks for each participant.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Overtly healthy participants as determined by medical history and physical examination
To qualify as Japanese for the purpose of this study, the Japanese participant must be first-generation Japanese
Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m\^2) and have a minimum body weight of 50 kilograms (kg), inclusive at screening
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion criteria

Exclusion Criteria:

Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have an abnormal blood pressure that is considered to be clinically significant, as determined by the investigator
Have a history or presence of 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 known or ongoing psychiatric disorders
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Single group
Masking: Double (Participant, Investigator)
Enrollment: 48 participants (actual)

Study arms

Experimental
LY3079514
Single dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion
Drug: LY3079514
Placebo comparator
Placebo
Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.
Drug: Placebo

Interventions

DrugLY3079514
Administered SC
DrugLY3079514
Administered IV
DrugPlacebo
Administered SC
DrugPlacebo
Administered IV

What researchers measure

Primary outcomes

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Baseline to Study Completion (Up to 12 Weeks)

Secondary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514
Time frame: SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85
PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514
Time frame: SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85

Results

Posted Oct 4, 2018

Participant flow

Participant flow — Overall Study
Milestone	Placebo	LY3079514 Cohort 1	LY3079514 Cohort 2	LY3079514 Cohort 3	LY3079514 Cohort 4	LY3079514 Cohort 5	LY3079514 Cohort 6
Started	12	6	6	6	6	6	6
Received at least one dose of study drug	12	6	6	6	6	6	6
Completed	11	6	6	6	6	6	6
Not completed	1	0	0	0	0	0	0
Withdrew: Withdrawal by subject	1	0	0	0	0	0	0

Outcome measures

PrimaryNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.

Time frame:: Baseline to Study Completion (Up to 12 Weeks)
Reported as:: Number · participants

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
participants	Placebo	LY3079514 (LY) Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	0	0	0	0	0	0	0

SecondaryPharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514

Time frame:: SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85
Reported as:: Geometric mean · nanograms/milliliter (ng/mL)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514
nanograms/milliliter (ng/mL)	LY Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514	55.1 ± 93	480 ± 64	3150 ± 118	16900 ± 45	19000 ± 13	41300 ± 22

SecondaryPK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514

Time frame:: SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85
Reported as:: Geometric mean · nanogram•hour/milliliter (ng•h/mL)

PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514
nanogram•hour/milliliter (ng•h/mL)	LY Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6
PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514	—	38500 ± 59	402000 ± 80	4850000 ± 37	1240000 ± 20	6470000 ± 14

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	0/12 (0%)	1/12 (8.3%)
LY3079514 (LY) Cohort 1	—	0/6 (0%)	4/6 (66.7%)
LY Cohort 2	—	0/6 (0%)	1/6 (16.7%)
LY Cohort 3	—	0/6 (0%)	3/6 (50%)
LY Cohort 4	—	0/6 (0%)	4/6 (66.7%)
LY Cohort 5	—	0/6 (0%)	3/6 (50%)
LY Cohort 6	—	0/6 (0%)	4/6 (66.7%)

Most frequent other events

Showing 10 of 26

Most frequent other events
Event	Placebo	LY3079514 (LY) Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6
Eye swellingEye disorders	0/12	0/6	0/6	0/6	2/6	0/6	1/6
Periorbital oedemaEye disorders	0/12	0/6	0/6	0/6	0/6	0/6	2/6
Upper respiratory tract infectionInfections and infestations	0/12	2/6	0/6	1/6	1/6	0/6	0/6
Postmenopausal haemorrhageReproductive system and breast disorders	0/12	0/6	0/6	0/6	1/3	0/6	0/6
Premenstrual headacheReproductive system and breast disorders	0/12	0/6	0/6	0/6	1/3	0/6	0/6
Eyelid oedemaEye disorders	0/12	0/6	0/6	0/6	1/6	0/6	0/6
Abdominal pain lowerGastrointestinal disorders	0/12	0/6	0/6	0/6	0/6	0/6	1/6
Generalised oedemaGeneral disorders	0/12	0/6	0/6	0/6	0/6	0/6	1/6
Instillation site bruiseGeneral disorders	0/12	0/6	1/6	0/6	0/6	0/6	0/6
OedemaGeneral disorders	0/12	0/6	0/6	0/6	0/6	0/6	1/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	LY3079514 (LY) Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6	Total
Mean	41.1 ± 11.96	35.5 ± 10.82	34.5 ± 12.42	38.0 ± 12.82	45.3 ± 12.39	39.0 ± 11.56	49.3 ± 5.61	40.5 ± 11.65

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	LY3079514 (LY) Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6	Total
Female	4	1	1	0	3	0	3	12
Male	8	5	5	6	3	6	3	36

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	LY3079514 (LY) Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6	Total
Hispanic or Latino	1	0	1	1	1	1	1	6
Not Hispanic or Latino	11	6	5	5	5	5	5	42
Unknown or Not Reported	0	0	0	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Placebo	LY3079514 (LY) Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6	Total
Japanese	3	0	3	0	3	0	3	12
Non-Japanese	9	6	3	6	3	6	3	36

Region of Enrollment
Region of Enrollment(participants)	Placebo	LY3079514 (LY) Cohort 1	LY Cohort 2	LY Cohort 3	LY Cohort 4	LY Cohort 5	LY Cohort 6	Total
United States	12	6	6	6	6	6	6	48

Study locations

1 site

California Clinical Trials Medical Group
Glendale, California 91206, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02242903
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Sep 17, 2014
Start date: Oct 2014
Primary completion: Jun 2015
Completion: Jun 2015
Results posted: Oct 4, 2018
Last update: Oct 4, 2018

Study contacts

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)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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