Trial Outcomes & Findings for A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women (NCT NCT01742091)
NCT ID: NCT01742091
Last Updated: 2018-07-18
Results Overview
An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * is considered significant by the investigator for any other reason
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
59 participants
Primary outcome timeframe
Day 1 through Day 141
Results posted on
2018-07-18
Participant Flow
Participant milestones
| Measure |
180 mg LY2541546 SC Q4W
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
10
|
9
|
8
|
12
|
|
Overall Study
RECEIVED STUDY DRUG
|
9
|
11
|
10
|
9
|
8
|
12
|
|
Overall Study
COMPLETED
|
9
|
11
|
10
|
8
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
180 mg LY2541546 SC Q4W
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women
Baseline characteristics by cohort
| Measure |
180 mg LY2541546 SC Q4W
n=9 Participants
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
n=11 Participants
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
n=10 Participants
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
n=9 Participants
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
n=8 Participants
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
n=12 Participants
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
57 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
56 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
57 years
STANDARD_DEVIATION 8.3 • n=4 Participants
|
66 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
62 years
STANDARD_DEVIATION 10.5 • n=10 Participants
|
59 years
STANDARD_DEVIATION 8.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
59 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=10 Participants
|
12 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
4 participants
n=21 Participants
|
8 participants
n=10 Participants
|
45 participants
n=115 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
8 participants
n=21 Participants
|
12 participants
n=10 Participants
|
59 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 141Population: All participants who received study drug.
An SAE is any AE from this study that results in one of the following outcomes: * death * initial or prolonged inpatient hospitalization * a life-threatening experience (that is, immediate risk of dying) * persistent or significant disability/incapacity * congenital anomaly/birth defect * is considered significant by the investigator for any other reason
Outcome measures
| Measure |
180 mg LY2541546 SC Q4W
n=9 Participants
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
n=11 Participants
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
n=10 Participants
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
n=9 Participants
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
n=8 Participants
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
n=12 Participants
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
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
|
SECONDARY outcome
Timeframe: Day 1 through Day 141Population: All participants who received study drug and had sufficient evaluable results for PK analysis.
Weekly AUC (AUC\[0-tau\]) during the first and last dosing interval for each participant receiving LY2541546 is reported.
Outcome measures
| Measure |
180 mg LY2541546 SC Q4W
n=8 Participants
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
n=11 Participants
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
n=10 Participants
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
n=8 Participants
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
n=7 Participants
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546
First Dose
|
6.77 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 2.00
|
18.5 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 5.27
|
13.9 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 4.73
|
61.2 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 7.23
|
167 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 11.9
|
—
|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546
Last Dose
|
6.85 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 2.09
|
38.4 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 13.3
|
14.7 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 5.45
|
68.9 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 11.4
|
332 nanomole x hour per mililiter (nmol*h/mL
Standard Deviation 54.6
|
—
|
SECONDARY outcome
Timeframe: Predose and Day 85Population: All participants who received study drug and had evaluable BMD results at the analyzed time points.
A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²). The least squares (LS) mean was adjusted for baseline lumbar spine BMD and treatment group.
Outcome measures
| Measure |
180 mg LY2541546 SC Q4W
n=9 Participants
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
n=11 Participants
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
n=10 Participants
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
n=8 Participants
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
n=7 Participants
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
n=11 Participants
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85
|
0.02 gram per square centimeter (g/cm^2)
Interval 0.0 to 0.04
|
0.05 gram per square centimeter (g/cm^2)
Interval 0.03 to 0.06
|
0.03 gram per square centimeter (g/cm^2)
Interval 0.02 to 0.04
|
0.05 gram per square centimeter (g/cm^2)
Interval 0.03 to 0.07
|
0.06 gram per square centimeter (g/cm^2)
Interval 0.04 to 0.08
|
0.00 gram per square centimeter (g/cm^2)
Interval -0.01 to 0.02
|
SECONDARY outcome
Timeframe: Predose (Day 1) and Postdose (Day 29, 85 and 141)Population: All participants who received study drug and had evaluable antibody results at the analyzed time points.
Outcome measures
| Measure |
180 mg LY2541546 SC Q4W
n=9 Participants
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
n=11 Participants
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
n=10 Participants
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
n=9 Participants
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
n=8 Participants
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
n=12 Participants
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Day 1
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Day 29
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Day 85
|
3 participants
|
2 participants
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
Day 141
|
3 participants
|
2 participants
|
2 participants
|
1 participants
|
5 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose, through Day 141Population: All participants who received study drug and had evaluable P1NP results at the analyzed time points.
N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. Least squares (LS) mean was adjusted for baseline P1NP, treatment group, time (i.e. study day), and interaction between treatment group and time.
Outcome measures
| Measure |
180 mg LY2541546 SC Q4W
n=9 Participants
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
n=11 Participants
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
n=10 Participants
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
n=8 Participants
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
n=7 Participants
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
n=11 Participants
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
Day 29
|
20.36 microgram per liter (ug/L)
Interval -4.53 to 45.26
|
121.68 microgram per liter (ug/L)
Interval 99.15 to 144.2
|
42.60 microgram per liter (ug/L)
Interval 18.98 to 66.23
|
124.47 microgram per liter (ug/L)
Interval 98.12 to 150.82
|
134.93 microgram per liter (ug/L)
Interval 107.36 to 162.5
|
1.36 microgram per liter (ug/L)
Interval -20.71 to 23.44
|
|
Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
Day 85
|
1.69 microgram per liter (ug/L)
Interval -15.88 to 19.27
|
24.19 microgram per liter (ug/L)
Interval 8.28 to 40.09
|
9.66 microgram per liter (ug/L)
Interval -7.02 to 26.34
|
52.44 microgram per liter (ug/L)
Interval 33.72 to 71.16
|
91.06 microgram per liter (ug/L)
Interval 71.25 to 110.86
|
4.20 microgram per liter (ug/L)
Interval -11.36 to 19.75
|
Adverse Events
180 mg LY2541546 SC Q4W
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
270 mg LY2541546 SC Q2W
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
270 mg LY2541546 SC Q4W
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
540 mg LY2541546 IV Q4W
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
750 mg LY2541546 IV Q2W
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Q2W
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
180 mg LY2541546 SC Q4W
n=9 participants at risk
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
n=11 participants at risk
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
n=10 participants at risk
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
n=9 participants at risk
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
n=8 participants at risk
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
n=12 participants at risk
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
Other adverse events
| Measure |
180 mg LY2541546 SC Q4W
n=9 participants at risk
180 milligram (mg) LY2541546 administered subcutaneous (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
270 mg LY2541546 SC Q2W
n=11 participants at risk
270 mg LY2541546 administered (SC) once every 2 weeks (Q2W) for 8 weeks.
|
270 mg LY2541546 SC Q4W
n=10 participants at risk
270 mg LY2541546 administered (SC) once every 4 weeks (Q4W) for 8 weeks. Placebo administered SC at Weeks 2 and 6 to maintain the blind.
|
540 mg LY2541546 IV Q4W
n=9 participants at risk
540 mg administered intravenous (IV) once every 4 weeks (Q4W) for 8 weeks. Placebo administered IV at Weeks 2 and 6 to maintain the blind.
|
750 mg LY2541546 IV Q2W
n=8 participants at risk
750 mg administered (IV) once every 2 weeks (Q2W) for 8 weeks.
|
Placebo Q2W
n=12 participants at risk
Placebo administered IV or SC once every 2 weeks for 8 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Ear Congestion
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Ear and labyrinth disorders
Ear Pain
|
11.1%
1/9 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Distension
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 2
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 3
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
20.0%
2/10 • Number of events 3
|
0.00%
0/9
|
12.5%
1/8 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Chest Discomfort
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Chills
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Injection Site Discomfort
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Injection Site Erythema
|
0.00%
0/9
|
36.4%
4/11 • Number of events 5
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Injection Site Haemorrhage
|
22.2%
2/9 • Number of events 2
|
18.2%
2/11 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Injection Site Inflammation
|
0.00%
0/9
|
0.00%
0/11
|
20.0%
2/10 • Number of events 4
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Injection Site Mass
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Injection Site Pain
|
11.1%
1/9 • Number of events 1
|
36.4%
4/11 • Number of events 4
|
20.0%
2/10 • Number of events 2
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Injection Site Pruritus
|
0.00%
0/9
|
18.2%
2/11 • Number of events 2
|
10.0%
1/10 • Number of events 2
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Injection Site Rash
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Injection Site Reaction
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Injection Site Warmth
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Pain
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Sensation of Pressure
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Vessel Puncture Site Haematoma
|
11.1%
1/9 • Number of events 2
|
0.00%
0/11
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/12
|
|
General disorders
Vessel Puncture Site Pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/12
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Rhinitis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
20.0%
2/10 • Number of events 2
|
0.00%
0/9
|
25.0%
2/8 • Number of events 2
|
25.0%
3/12 • Number of events 3
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Burns First Degree
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/9
|
18.2%
2/11 • Number of events 3
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/12
|
|
Investigations
Blood Thyroid Stimulating Hormone Decreased
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 3
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
22.2%
2/9 • Number of events 2
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
11.1%
1/9 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/9
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
2/9 • Number of events 2
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Nervous system disorders
Head Discomfort
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
40.0%
4/10 • Number of events 8
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
41.7%
5/12 • Number of events 7
|
|
Nervous system disorders
Lethargy
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Somnolence
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
0.00%
0/8
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
22.2%
2/9 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/9
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 2
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Vascular disorders
Flushing
|
0.00%
0/9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
|
Vascular disorders
Hot Flush
|
11.1%
1/9 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/12
|
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