Trial Outcomes & Findings for A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants (NCT NCT02109042)
NCT ID: NCT02109042
Last Updated: 2018-07-16
Results Overview
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Predose and daily up through 7 days postdose
Results posted on
2018-07-16
Participant Flow
Participant milestones
| Measure |
Weekly Subcutaneous Blosozumab Injections
Blosozumab was to be administered as a subcutaneous (SC) injection (90 milligrams per milliliter (mg/mL) solution in prefilled syringes) weekly for 6 weeks.
A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
15
|
|
Overall Study
Received 180 mg Loading Dose
|
15
|
|
Overall Study
Receive at Least 1 Subsequent 90 mg Dose
|
15
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Weekly Subcutaneous Blosozumab Injections
Blosozumab was to be administered as a subcutaneous (SC) injection (90 milligrams per milliliter (mg/mL) solution in prefilled syringes) weekly for 6 weeks.
A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2.
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|---|---|
|
Overall Study
Sponsor Decision
|
15
|
Baseline Characteristics
A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
Baseline characteristics by cohort
| Measure |
Weekly SC Blosozumab Injections
n=15 Participants
Blosozumab was to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.
A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2.
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|---|---|
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Age, Continuous
|
68.6 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose and daily up through 7 days postdosePopulation: Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.
The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.
Outcome measures
| Measure |
Weekly SC Blosozumab Injections
n=15 Participants
Blosozumab was to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.
A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2.
|
|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab
|
59.8 picomoles per milliliter
Geometric Coefficient of Variation 54
|
PRIMARY outcome
Timeframe: Predose and daily up through 7 days postdosePopulation: Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.
The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.
Outcome measures
| Measure |
Weekly SC Blosozumab Injections
n=15 Participants
Blosozumab was to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.
A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1 followed by 5 planned once weekly 90 mg doses (single 1 mL injection) beginning on Day 1 of Week 2.
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|---|---|
|
PK: Area Under the Concentration Curve of Blosozumab
|
7160 picomoles times hours per milliliter
Geometric Coefficient of Variation 58
|
Adverse Events
180 mg SC Blosozumab Injection
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
90 mg SC Blosozumab Injections
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
180 mg SC Blosozumab Injection
n=15 participants at risk
Blosozumab was planned to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.
A 180 mg loading dose (2 × 1 mL injections) was administered on Day 1 of Week 1.
|
90 mg SC Blosozumab Injections
n=15 participants at risk
Blosozumab was planned to be administered as a SC injection (90 mg/mL solution in prefilled syringes) weekly for 6 weeks.
Once weekly 90 mg dose (single 1 mL injection) were administered beginning on Day 1 of Week 2.
Data from all participants who received at least 1 90 mg/mL SC Blozozumab injection are included.
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|---|---|---|
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Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Number of events 3
|
0.00%
0/15
|
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General disorders
Injection site dermatitis
|
0.00%
0/15
|
33.3%
5/15 • Number of events 5
|
|
General disorders
Injection site erythema
|
73.3%
11/15 • Number of events 20
|
86.7%
13/15 • Number of events 26
|
|
General disorders
Injection site haemorrhage
|
20.0%
3/15 • Number of events 3
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Injection site induration
|
0.00%
0/15
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Injection site oedema
|
60.0%
9/15 • Number of events 15
|
26.7%
4/15 • Number of events 4
|
|
General disorders
Injection site pain
|
20.0%
3/15 • Number of events 6
|
40.0%
6/15 • Number of events 10
|
|
General disorders
Injection site pruritus
|
0.00%
0/15
|
53.3%
8/15 • Number of events 13
|
|
General disorders
Injection site swelling
|
0.00%
0/15
|
26.7%
4/15 • Number of events 4
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Nervous system disorders
Headache
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
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