A Study of LY3053102 in Healthy Participants
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01736241
Collaborator
(none)
41
1
2
7
5.9
Study Details
Study Description
Brief Summary
The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3053102 in Healthy Subjects
Study Start Date
:
Dec 1, 2012
Actual Primary Completion Date
:
Jul 1, 2013
Actual Study Completion Date
:
Jul 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3053102 A single 2-, 7-, 20-, 50-, 150-, or 405-milligrams (mg) dose of LY3053102 was subcutaneously administered to newly randomized participants in 6 escalating dose level cohorts. The dose was escalated based on the safety results over at least a 7-day evaluation period postdose. The dose escalation occurred over 13 weeks proceeding according to tolerability at each dose level. |
Drug: LY3053102
|
| Placebo Comparator: Placebo A single dose of LY3053102-matching placebo was administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort over 13 weeks. |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs [Baseline through Day 31]
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Secondary Outcome Measures
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 [Time 0 to 168 hours after study drug administration on Day 1]
AUC curve from time 0 to 168 hours postdose of LY3053102.
- PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 [Time 0 to 168 hours after study drug administration on Day 1]
Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.
- Number of Participants Who Developed Anti-LY3053102 Antibodies [Baseline, up to Day 31]
LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Normal blood pressure
-
Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
-
Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m^2), inclusive, at screening
Exclusion Criteria:
-
Had known allergies to LY3053102 or related compounds
-
Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
-
Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids
-
Heavy smokers (more than 10 cigarettes a day)
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. | Singapore | Singapore | 117597 |
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:
NCT01736241
Other Study ID Numbers:
- 14514
- I6I-MC-LMRA
First Posted:
Nov 29, 2012
Last Update Posted:
Jul 19, 2018
Last Verified:
Sep 1, 2017
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 | Placebo |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 405 mg, administered subcutaneously. | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort. |
| Period Title: Overall Study | |||||||
| STARTED | 6 | 6 | 6 | 5 | 6 | 6 | 6 |
| Received at Least One Dose of Study Drug | 6 | 6 | 6 | 5 | 6 | 6 | 6 |
| COMPLETED | 6 | 6 | 6 | 5 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 | Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose. | LY3053102: A single dose of 405 mg, administered subcutaneously. | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort. | Total of all reporting groups |
| Overall Participants | 6 | 6 | 6 | 5 | 6 | 6 | 6 | 41 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
35.2
(9.7)
|
33.2
(4.3)
|
39.7
(11.1)
|
36.2
(14.7)
|
34.3
(10.7)
|
31.0
(8.9)
|
34.5
(7.4)
|
34.8
(9.4)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
1
16.7%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
4.9%
|
| Male |
5
83.3%
|
6
100%
|
5
83.3%
|
5
100%
|
6
100%
|
6
100%
|
6
100%
|
39
95.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
6
100%
|
6
100%
|
6
100%
|
5
100%
|
6
100%
|
6
100%
|
6
100%
|
41
100%
|
| 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 |
6
100%
|
6
100%
|
5
83.3%
|
5
100%
|
5
83.3%
|
6
100%
|
5
83.3%
|
38
92.7%
|
| 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 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
1
16.7%
|
0
0%
|
1
16.7%
|
3
7.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||||
| Singapore |
6
100%
|
6
100%
|
6
100%
|
5
100%
|
6
100%
|
6
100%
|
6
100%
|
41
100%
|
Outcome Measures
| Title | Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs |
|---|---|
| Description | A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Time Frame | Baseline through Day 31 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least one dose of LY3053102 or placebo. |
| Arm/Group Title | 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 | Placebo |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. | LY3053102: A single dose of 7 mg, administered subcutaneously. | LY3053102: A single dose of 20 mg, administered subcutaneously. | LY3053102: A single dose of 50 mg, administered subcutaneously. | LY3053102: A single dose of 150 mg, administered subcutaneously. | LY3053102: A single dose of 405 mg, administered subcutaneously. | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort. |
| Measure Participants | 6 | 6 | 6 | 5 | 6 | 6 | 6 |
| Number [participants] |
5
83.3%
|
6
100%
|
4
66.7%
|
4
80%
|
6
100%
|
5
83.3%
|
6
100%
|
| Title | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102 |
|---|---|
| Description | AUC curve from time 0 to 168 hours postdose of LY3053102. |
| Time Frame | Time 0 to 168 hours after study drug administration on Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data. |
| Arm/Group Title | 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 |
|---|---|---|---|---|---|---|
| Arm/Group Description | LY3053102: A single dose of 2 mg, administered subcutaneously. | LY3053102: A single dose of 7 mg, administered subcutaneously. | LY3053102: A single dose of 20 mg, administered subcutaneously. | LY3053102: A single dose of 50 mg, administered subcutaneously. | LY3053102: A single dose of 150 mg, administered subcutaneously. | LY3053102: A single dose of 405 mg, administered subcutaneously. |
| Measure Participants | 6 | 6 | 6 | 5 | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [microgram*hour/milliliter] |
7.24
(29.6)
|
16.1
(50.3)
|
94.0
(45.5)
|
192
(38.0)
|
481
(74.0)
|
1810
(49.1)
|
| Title | PK: Observed Maximum Drug Concentration (Cmax) of LY3053102 |
|---|---|
| Description | Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1. |
| Time Frame | Time 0 to 168 hours after study drug administration on Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data. |
| Arm/Group Title | 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 |
|---|---|---|---|---|---|---|
| Arm/Group Description | LY3053102: A single dose of 2 mg, administered subcutaneously. | LY3053102: A single dose of 7 mg, administered subcutaneously. | LY3053102: A single dose of 20 mg, administered subcutaneously. | LY3053102: A single dose of 50 mg, administered subcutaneously. | LY3053102: A single dose of 150 mg, administered subcutaneously. | LY3053102: A single dose of 405 mg, administered subcutaneously. |
| Measure Participants | 6 | 6 | 6 | 5 | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [microgram/milliliter] |
0.0693
(30.2)
|
0.140
(52.0)
|
0.784
(46.8)
|
1.68
(44.7)
|
4.49
(67.6)
|
16.2
(49.0)
|
| Title | Number of Participants Who Developed Anti-LY3053102 Antibodies |
|---|---|
| Description | LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized. |
| Time Frame | Baseline, up to Day 31 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received at least one dose of LY3053102 or placebo and with evaluable anti-drug (LY3053102) ADA data. |
| Arm/Group Title | 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 | Placebo |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | LY3053102: A single dose of 2 mg, administered subcutaneously. | LY3053102: A single dose of 7 mg, administered subcutaneously. | LY3053102: A single dose of 20 mg, administered subcutaneously. | LY3053102: A single dose of 50 mg, administered subcutaneously. | LY3053102: A single dose of 150 mg, administered subcutaneously. | LY3053102: A single dose of 405 mg, administered subcutaneously. | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort. |
| Measure Participants | 6 | 6 | 6 | 5 | 6 | 6 | 6 |
| Day 15 |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Day 29 |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 | Placebo | |||||||
| Arm/Group Description | LY3053102: A single dose of 2 mg, administered subcutaneously. | LY3053102: A single dose of 7 mg, administered subcutaneously. | LY3053102: A single dose of 20 mg, administered subcutaneously. | LY3053102: A single dose of 50 mg, administered subcutaneously. | LY3053102: A single dose of 150 mg, administered subcutaneously. | LY3053102: A single dose of 405 mg, administered subcutaneously. | Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort. | |||||||
All Cause Mortality |
||||||||||||||
| 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 | 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 |
||||||||||||||
| 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 | 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 | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/5 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| 2 mg LY3053102 | 7 mg LY3053102 | 20 mg LY3053102 | 50 mg LY3053102 | 150 mg LY3053102 | 405 mg LY3053102 | 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 | 5/6 (83.3%) | 6/6 (100%) | 4/6 (66.7%) | 4/5 (80%) | 6/6 (100%) | 5/6 (83.3%) | 6/6 (100%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal distension | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Diarrhoea | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 3/6 (50%) | 3 | 1/6 (16.7%) | 1 |
| Dry mouth | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Mouth ulceration | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nausea | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 3/6 (50%) | 3 | 0/6 (0%) | 0 |
| Vomiting | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| General disorders | ||||||||||||||
| Feeling cold | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Injection site erythema | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Injection site haematoma | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Pyrexia | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 |
| Temperature intolerance | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Thirst | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Arthropod bite | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Excoriation | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Laceration | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Procedural site reaction | 3/6 (50%) | 4 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/5 (20%) | 1 | 1/6 (16.7%) | 3 | 2/6 (33.3%) | 3 | 5/6 (83.3%) | 6 |
| Scratch | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||
| Increased appetite | 2/6 (33.3%) | 2 | 5/6 (83.3%) | 5 | 4/6 (66.7%) | 4 | 2/5 (40%) | 2 | 5/6 (83.3%) | 5 | 5/6 (83.3%) | 5 | 1/6 (16.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Myalgia | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| Dysgeusia | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Headache | 1/6 (16.7%) | 1 | 3/6 (50%) | 3 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Tremor | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||
| Tobacco abuse | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 | 2/6 (33.3%) | 2 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| Oropharyngeal pain | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Rhinorrhoea | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Dermatitis contact | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Rash erythematous | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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:
NCT01736241
Other Study ID Numbers:
- 14514
- I6I-MC-LMRA
First Posted:
Nov 29, 2012
Last Update Posted:
Jul 19, 2018
Last Verified:
Sep 1, 2017