A Study of LY3050258 in Healthy Participants
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02121834
Collaborator
(none)
63
1
2
6
10.5
Study Details
Study Description
Brief Summary
This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This study will evaluate the safety and how well the body tolerates LY3050258. It will last approximately 14 weeks with a 2 week follow-up appointment after the last treatment with study drug.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Multiple-Dose, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of LY3050258
Study Start Date
:
Jun 1, 2014
Actual Primary Completion Date
:
Dec 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3050258 Daily dose of LY3050258 for 28 days: Cohort A 10 mg, Cohort B 30 mg, Cohort C 90 mg, Cohort D 180 mg and Cohort E 360 mg. |
Drug: LY3050258
Drug: Placebo
|
| Placebo Comparator: Placebo Daily dose of placebo matching LY3050258 for 28 days. |
Drug: LY3050258
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline to Study Completion (Up to 14 Weeks)]
Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Secondary Outcome Measures
- Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 [Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs]
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 [Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs]
Eligibility Criteria
Criteria
Ages Eligible for Study:
30 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy males or healthy postmenopausal females, including Japanese participants
-
Body mass index (BMI) of 18 and 35 kilograms per square meter (kg/m^2), inclusive
Exclusion Criteria:
-
Abnormal siting blood pressure as determined by the investigator
-
Abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, places the participant at an unacceptable risk for study participation
-
Aspartate aminotransferase (AST) or alkaline phosphatase (ALT) greater than 2 times the upper limit of normal (ULN)
-
Skin condition that in the opinion of the investigator makes the participant unsuitable for study participation
-
Current use of statins within the last 3 months prior to dosing
-
Current use or previous use of anabolic steroids in the preceding 6 months prior to dosing
-
Use of dehydroepiandrosterone, other potential over-the-counter steroidal supplements, or other nutritional products intended to have weight-reduction and/or performance-enhancing effects within 21 days prior to dosing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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. | Cypress | California | United States | 90630 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02121834
Other Study ID Numbers:
- 14936
- I6R-MC-DLAB
First Posted:
Apr 24, 2014
Last Update Posted:
Jul 27, 2018
Last Verified:
Jul 1, 2018
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort A-D Placebo | Cohort A: 10 Milligram (mg) LY3050258 | Cohort B: 30 mg LY3050258 | Cohort C: 90 mg LY3050258 | Cohort D: 180 mg LY3050258 | Cohort E: 360 mg LY3050258 | Cohort E Placebo |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo daily for 28 days | 10 mg LY3050258, daily for 28 days | 30mg LY3050258, daily for 28 days | 90 mg LY3050258, daily for 28 days | 180 mg LY3050258, daily for 28 days | 360 mg LY3050258, daily for 28 days | Placebo daily for 28 days |
| Period Title: Overall Study | |||||||
| STARTED | 12 | 11 | 9 | 10 | 9 | 9 | 3 |
| Received at Least One Dose of Study Drug | 12 | 11 | 9 | 10 | 9 | 9 | 3 |
| COMPLETED | 12 | 9 | 7 | 10 | 9 | 9 | 3 |
| NOT COMPLETED | 0 | 2 | 2 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Cohort A-D Placebo | Cohort A: LY3050258 | Cohort B: LY3050258 | Cohort C: LY3050258 | Cohort D: LY3050258 | Cohort E: LY3050258 | Cohort E Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo daily for 28 days | 10 mg LY3050258, daily for 28 days | 30 mg LY3050258, daily for 28 days | 90 mg LY3050258, daily for 28 days | 180 mg LY3050258, daily for 28 days | 360 mg LY3050258, daily for 28 days | Placebo daily for 28 days | Total of all reporting groups |
| Overall Participants | 12 | 11 | 9 | 10 | 9 | 9 | 3 | 63 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
48.4
(12.2)
|
50.5
(9.8)
|
51.6
(9.1)
|
52.8
(10.4)
|
44.6
(10.6)
|
47.8
(10.5)
|
35.7
(5.5)
|
48.7
(10.6)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
4
33.3%
|
6
54.5%
|
3
33.3%
|
2
20%
|
3
33.3%
|
3
33.3%
|
0
0%
|
21
33.3%
|
| Male |
8
66.7%
|
5
45.5%
|
6
66.7%
|
8
80%
|
6
66.7%
|
6
66.7%
|
3
100%
|
42
66.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
0
0%
|
5
45.5%
|
2
22.2%
|
3
30%
|
0
0%
|
5
55.6%
|
2
66.7%
|
17
27%
|
| Not Hispanic or Latino |
12
100%
|
6
54.5%
|
7
77.8%
|
7
70%
|
9
100%
|
4
44.4%
|
1
33.3%
|
46
73%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
3
25%
|
1
9.1%
|
2
22.2%
|
3
30%
|
3
33.3%
|
2
22.2%
|
1
33.3%
|
15
23.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
25%
|
3
27.3%
|
2
22.2%
|
1
10%
|
4
44.4%
|
1
11.1%
|
0
0%
|
14
22.2%
|
| White |
6
50%
|
5
45.5%
|
5
55.6%
|
6
60%
|
2
22.2%
|
5
55.6%
|
2
66.7%
|
31
49.2%
|
| More than one race |
0
0%
|
2
18.2%
|
0
0%
|
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
3
4.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||||||
| United States |
12
100%
|
11
100%
|
9
100%
|
10
100%
|
9
100%
|
9
100%
|
3
100%
|
63
100%
|
Outcome Measures
| Title | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
|---|---|
| Description | Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Time Frame | Baseline to Study Completion (Up to 14 Weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug. |
| Arm/Group Title | Placebo Cohort A-D | 10 mg LY3050258 | 30 mg LY3050258 | 90 mg LY3050258 | 180 mg LY3050258 | 360 mg LY3050258 | Placebo Cohort E |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo daily for 28 days | 10 mg LY3050258, daily for 28 days | 30 mg LY3050258, daily for 28 days | 90 mg LY3050258, daily for 28 days | 180 mg LY3050258, daily for 28 days | 360 mg LY3050258, daily for 28 days | Placebo daily for 28 days |
| Measure Participants | 12 | 11 | 9 | 10 | 9 | 9 | 3 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258 |
|---|---|
| Description | |
| Time Frame | Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug and had measurable AUC PK concentrations after dosing. |
| Arm/Group Title | 10mg LY3050258 | 30mg LY3050258 | 90mg LY3050258 | 180mg LY3050258 | 360mg LY3050258 |
|---|---|---|---|---|---|
| Arm/Group Description | 10 mg LY3050258, daily for 28 days | 30 mg LY3050258, daily for 28 days | 90 mg LY3050258, daily for 28 days | 180 mg LY3050258, daily for 28 days | 360mg LY3050258, daily for 28 days |
| Measure Participants | 9 | 7 | 9 | 9 | 9 |
| Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng*hr/mL)] |
14.5
(81)
|
24.1
(55)
|
55.6
(62)
|
70.0
(50)
|
84.5
(65)
|
| Title | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258 |
|---|---|
| Description | |
| Time Frame | Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug and had measurable Cmax PK concentrations after dosing. |
| Arm/Group Title | 10 mg LY3050258 | 30 mg LY3050258 | 90 mg LY3050258 | 180 mg LY3050258 | 360 mg LY3050258 |
|---|---|---|---|---|---|
| Arm/Group Description | 10 mg LY3050258, daily for 28 days | 30 mg LY3050258, daily for 28 days | 90 mg LY3050258, daily for 28 days | 180 mg LY3050258, daily for 28 days | 360 mg LY3050258, daily for 28 days |
| Measure Participants | 9 | 8 | 9 | 9 | 9 |
| Geometric Mean (Geometric Coefficient of Variation) [nanogram per milliliter (ng/mL)] |
0.899
(93)
|
1.35
(63)
|
3.58
(61)
|
4.51
(57)
|
4.99
(62)
|
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | Cohort A-D Placebo | Cohort A: 10 mg LY3050258 | Cohort B: 30 mg LY3050258 | Cohort C: 90 mg LY3050258 | Cohort D: 180 mg LY3050258 | Cohort E: 360 mg LY3050258 | Cohort E: Placebo | |||||||
| Arm/Group Description | Placebo daily for 28 days | 10 mg LY3050258, daily for 28 days | 30 mg LY3050258, daily for 28 days | 90 mg LY3050258, daily for 28 days | 180 mg LY3050258, daily for 28 days | 360 mg LY3050258, daily for 28 days | Placebo daily for 28 days | |||||||
All Cause Mortality |
||||||||||||||
| Cohort A-D Placebo | Cohort A: 10 mg LY3050258 | Cohort B: 30 mg LY3050258 | Cohort C: 90 mg LY3050258 | Cohort D: 180 mg LY3050258 | Cohort E: 360 mg LY3050258 | Cohort E: Placebo | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| Cohort A-D Placebo | Cohort A: 10 mg LY3050258 | Cohort B: 30 mg LY3050258 | Cohort C: 90 mg LY3050258 | Cohort D: 180 mg LY3050258 | Cohort E: 360 mg LY3050258 | Cohort E: Placebo | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/11 (0%) | 0/9 (0%) | 0/10 (0%) | 0/9 (0%) | 0/9 (0%) | 0/3 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Cohort A-D Placebo | Cohort A: 10 mg LY3050258 | Cohort B: 30 mg LY3050258 | Cohort C: 90 mg LY3050258 | Cohort D: 180 mg LY3050258 | Cohort E: 360 mg LY3050258 | Cohort E: Placebo | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/12 (41.7%) | 4/11 (36.4%) | 2/9 (22.2%) | 3/10 (30%) | 6/9 (66.7%) | 4/9 (44.4%) | 2/3 (66.7%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal pain upper | 0/12 (0%) | 0 | 1/11 (9.1%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Diarrhoea | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Nausea | 0/12 (0%) | 0 | 1/11 (9.1%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Toothache | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Vomiting | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| General disorders | ||||||||||||||
| Application site erythema | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/3 (0%) | 0 |
| Application site irritation | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/3 (0%) | 0 |
| Application site pain | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 3/9 (33.3%) | 3 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Application site rash | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/3 (0%) | 0 |
| Application site reaction | 1/12 (8.3%) | 1 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/3 (0%) | 0 |
| Application site warmth | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Vessel puncture site reaction | 1/12 (8.3%) | 1 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| Upper respiratory tract infection | 0/12 (0%) | 0 | 1/11 (9.1%) | 1 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Viral upper respiratory tract infection | 0/12 (0%) | 0 | 1/11 (9.1%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Arthropod bite | 1/12 (8.3%) | 1 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Laceration | 0/12 (0%) | 0 | 1/11 (9.1%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Investigations | ||||||||||||||
| Electrocardiogram t wave abnormal | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/3 (33.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Back pain | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Myalgia | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/9 (11.1%) | 1 | 0/3 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| Dysgeusia | 0/12 (0%) | 0 | 1/11 (9.1%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 1/3 (33.3%) | 1 |
| Headache | 1/12 (8.3%) | 1 | 1/11 (9.1%) | 1 | 0/9 (0%) | 0 | 1/10 (10%) | 2 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Hypoaesthesia | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||||
| Urine odour abnormal | 0/12 (0%) | 0 | 1/11 (9.1%) | 1 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Nail discolouration | 1/12 (8.3%) | 1 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Rash maculo-papular | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
| Vascular disorders | ||||||||||||||
| Haematoma | 0/12 (0%) | 0 | 0/11 (0%) | 0 | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/9 (0%) | 0 | 0/3 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02121834
Other Study ID Numbers:
- 14936
- I6R-MC-DLAB
First Posted:
Apr 24, 2014
Last Update Posted:
Jul 27, 2018
Last Verified:
Jul 1, 2018