Trial Outcomes & Findings for A Study of LY2951742 in Healthy Japanese and Caucasian Participants (NCT NCT02104765)
NCT ID: NCT02104765
Last Updated: 2019-06-14
Results Overview
A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
Baseline through Day 197
Results posted on
2019-06-14
Participant Flow
Participant milestones
| Measure |
Placebo (SD)
1 subcutaneous (SC) dose of placebo
|
5 mg LY2951742 Single Dose (SD)
1 SC dose of 5 mg LY2951742
|
50 mg LY2951742 (SD)
1 SC dose of 50 mg LY2951742
|
120 mg LY2951742 (SD)
1 SC dose of 120 mg LY2951742
|
300 mg LY2951742 (SD)
1 SC dose of 300 mg LY2951742.
|
Placebo Q4W
3 SC doses of placebo every 4 Weeks (Q4W)
|
300 mg LY2951742 Q4W
3 SC doses of 300 mg LY2951742 Q4W
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
7
|
8
|
2
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
8
|
6
|
6
|
7
|
8
|
2
|
8
|
|
Overall Study
COMPLETED
|
8
|
6
|
5
|
6
|
7
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo (SD)
1 subcutaneous (SC) dose of placebo
|
5 mg LY2951742 Single Dose (SD)
1 SC dose of 5 mg LY2951742
|
50 mg LY2951742 (SD)
1 SC dose of 50 mg LY2951742
|
120 mg LY2951742 (SD)
1 SC dose of 120 mg LY2951742
|
300 mg LY2951742 (SD)
1 SC dose of 300 mg LY2951742.
|
Placebo Q4W
3 SC doses of placebo every 4 Weeks (Q4W)
|
300 mg LY2951742 Q4W
3 SC doses of 300 mg LY2951742 Q4W
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
A Study of LY2951742 in Healthy Japanese and Caucasian Participants
Baseline characteristics by cohort
| Measure |
Placebo (SD)
n=8 Participants
1 subcutaneous (SC) dose of placebo
|
5 mg LY2951742 Single Dose (SD)
n=6 Participants
1 SC dose of 5 mg LY2951742
|
50 mg LY2951742 (SD)
n=6 Participants
1 SC dose of 50 mg LY2951742
|
120 mg LY2951742 (SD)
n=7 Participants
1 SC dose of 120 mg LY2951742
|
300 mg LY2951742 (SD)
n=8 Participants
1 SC dose of 300 mg LY2951742.
|
Placebo Q4W
n=2 Participants
3 SC doses of placebo every 4 Weeks (Q4W)
|
300 mg LY2951742 Q4W
n=8 Participants
3 SC doses of 300 mg LY2951742 Q4W
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
35.5 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
NA years
STANDARD_DEVIATION NA • n=8 Participants
|
44.8 years
STANDARD_DEVIATION 11.0 • n=8 Participants
|
40.0 years
STANDARD_DEVIATION 11.0 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
45 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 197Population: All participants who received at least 1 dose of study drug.
A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section
Outcome measures
| Measure |
Placebo (SD)
n=8 Participants
1 subcutaneous (SC) dose of placebo
|
5 mg LY2951742 Single Dose (SD)
n=6 Participants
1 SC dose of 5 mg LY2951742
|
50 mg LY2951742 (SD)
n=6 Participants
1 SC dose of 50 mg LY2951742
|
120 mg LY2951742 (SD)
n=7 Participants
1 SC dose of 120 mg LY2951742
|
300 mg LY2951742 (SD)
n=8 Participants
1 SC dose of 300 mg LY2951742.
|
Placebo Q4W
n=2 Participants
3 SC doses of placebo Q4W
|
300 mg LY2951742 Q4W
n=8 Participants
3 SC doses of 300 mg LY2951742 Q4W
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose, 8 hr and 24 hour postdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data.
Cmax was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified.
Outcome measures
| Measure |
Placebo (SD)
n=6 Participants
1 subcutaneous (SC) dose of placebo
|
5 mg LY2951742 Single Dose (SD)
n=5 Participants
1 SC dose of 5 mg LY2951742
|
50 mg LY2951742 (SD)
n=7 Participants
1 SC dose of 50 mg LY2951742
|
120 mg LY2951742 (SD)
n=8 Participants
1 SC dose of 120 mg LY2951742
|
300 mg LY2951742 (SD)
n=7 Participants
1 SC dose of 300 mg LY2951742.
|
Placebo Q4W
3 SC doses of placebo Q4W
|
300 mg LY2951742 Q4W
3 SC doses of 300 mg LY2951742 Q4W
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742
|
775 nanogram/millliliter (ng/mL)
Geometric Coefficient of Variation 27
|
4270 nanogram/millliliter (ng/mL)
Geometric Coefficient of Variation 58
|
18000 nanogram/millliliter (ng/mL)
Geometric Coefficient of Variation 21
|
41400 nanogram/millliliter (ng/mL)
Geometric Coefficient of Variation 18
|
36300 nanogram/millliliter (ng/mL)
Geometric Coefficient of Variation 42
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 8 hr and 24 hour postdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data.
AUC was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified.
Outcome measures
| Measure |
Placebo (SD)
n=6 Participants
1 subcutaneous (SC) dose of placebo
|
5 mg LY2951742 Single Dose (SD)
n=5 Participants
1 SC dose of 5 mg LY2951742
|
50 mg LY2951742 (SD)
n=7 Participants
1 SC dose of 50 mg LY2951742
|
120 mg LY2951742 (SD)
n=8 Participants
1 SC dose of 120 mg LY2951742
|
300 mg LY2951742 (SD)
n=7 Participants
1 SC dose of 300 mg LY2951742.
|
Placebo Q4W
3 SC doses of placebo Q4W
|
300 mg LY2951742 Q4W
3 SC doses of 300 mg LY2951742 Q4W
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞])
|
27600 ng*hr/mL
Geometric Coefficient of Variation 24
|
173000 ng*hr/mL
Geometric Coefficient of Variation 51
|
733000 ng*hr/mL
Geometric Coefficient of Variation 38
|
1520000 ng*hr/mL
Geometric Coefficient of Variation 33
|
757000 ng*hr/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
Adverse Events
Placebo (SD)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
5 mg LY2951742 Single Dose (SD)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
50 mg LY2951742 (SD)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
120 mg LY2951742 (SD)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
300 mg LY2951742 (SD)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Q4W
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
300 mg LY2951742 Q4W
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (SD)
n=8 participants at risk
1 subcutaneous (SC) dose of placebo
|
5 mg LY2951742 Single Dose (SD)
n=6 participants at risk
1 SC dose 5 mg of LY2951742
|
50 mg LY2951742 (SD)
n=6 participants at risk
1 SC dose 50 mg LY2951742
|
120 mg LY2951742 (SD)
n=7 participants at risk
1 SC dose 120 mg of LY2951742
|
300 mg LY2951742 (SD)
n=8 participants at risk
2 SC doses 300 mg of LY2951742
|
Placebo Q4W
n=2 participants at risk
3 SC doses of placebo Q4W
|
300 mg LY2951742 Q4W
n=8 participants at risk
3 SC doses of 300 mg LY2951742 Q4W
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye irritation
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site erythema
|
37.5%
3/8 • Number of events 4
All participants who received at least 1 dose of study drug.
|
83.3%
5/6 • Number of events 5
All participants who received at least 1 dose of study drug.
|
66.7%
4/6 • Number of events 4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
75.0%
6/8 • Number of events 11
All participants who received at least 1 dose of study drug.
|
100.0%
2/2 • Number of events 5
All participants who received at least 1 dose of study drug.
|
75.0%
6/8 • Number of events 9
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
100.0%
2/2 • Number of events 2
All participants who received at least 1 dose of study drug.
|
50.0%
4/8 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
25.0%
2/8 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
62.5%
5/8 • Number of events 10
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
50.0%
1/2 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
16.7%
1/6 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/5
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/1
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/1
All participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
2/8 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
62.5%
5/8 • Number of events 5
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
12.5%
1/8 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/6
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/8
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/5
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/1
All participants who received at least 1 dose of study drug.
|
0.00%
0/2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/1
All participants who received at least 1 dose of study drug.
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60