Trial Outcomes & Findings for A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women (NCT NCT02337387)
NCT ID: NCT02337387
Last Updated: 2019-01-22
Results Overview
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Baseline through Day 85
Results posted on
2019-01-22
Participant Flow
This study was designed to have two parts. During Part A, one participant in each blosozumab treatment arm developed non-serious AEs, which met criteria for stopping the study. One participant was discontinued from the trial due to this AE. All other participants were discontinued due to trial termination. Part B was not conducted.
Participant milestones
| Measure |
Blosozumab Formulation A
Part A - Blosozumab Formulation A administered as a 180 milligram (mg) loading dose subcutaneously (SC) in Week 1 followed by 90 mg SC once weekly (QW) for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Blosozumab Formulation B
Part A - Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation A
Part A - Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation B
Part A - Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
8
|
3
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
14
|
8
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
3
|
3
|
Reasons for withdrawal
| Measure |
Blosozumab Formulation A
Part A - Blosozumab Formulation A administered as a 180 milligram (mg) loading dose subcutaneously (SC) in Week 1 followed by 90 mg SC once weekly (QW) for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Blosozumab Formulation B
Part A - Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation A
Part A - Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation B
Part A - Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Sponsor Decision to Terminate Study
|
14
|
7
|
3
|
3
|
Baseline Characteristics
A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
Baseline characteristics by cohort
| Measure |
Blosozumab Formulation A
n=14 Participants
Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Blosozumab Formulation B
n=8 Participants
Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation A
n=3 Participants
Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation B
n=3 Participants
Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 4.3 • n=93 Participants
|
58.1 years
STANDARD_DEVIATION 5.0 • n=4 Participants
|
56.3 years
STANDARD_DEVIATION 4.6 • n=27 Participants
|
56.0 years
STANDARD_DEVIATION 9.8 • n=483 Participants
|
58.3 years
STANDARD_DEVIATION 5.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 85Population: All participants who received at least 1 dose of study drug.
A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Blosozumab Formulation A
n=14 Participants
Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Blosozumab Formulation B
n=8 Participants
Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation A
n=3 Participants
Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation B
n=3 Participants
Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
|---|---|---|---|---|
|
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
|
SECONDARY outcome
Timeframe: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading DosePopulation: All participants who received the loading dose of blosozumab and had evaluable Cmax values.
Outcome measures
| Measure |
Blosozumab Formulation A
n=14 Participants
Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Blosozumab Formulation B
n=8 Participants
Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation A
Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation B
Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B
|
63.4 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 82
|
51.0 picomoles per milliliter (pmol/mL)
Geometric Coefficient of Variation 108
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading DosePopulation: All participants who received the loading dose of blosozumab and had evaluable Tmax values.
Outcome measures
| Measure |
Blosozumab Formulation A
n=14 Participants
Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Blosozumab Formulation B
n=8 Participants
Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation A
Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation B
Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
|---|---|---|---|---|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B
|
120 hours
Interval 72.0 to 168.0
|
120 hours
Interval 72.0 to 168.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading DosePopulation: All participants who received the loading dose of blosozumab and had evaluable AUC(0-tau) values.
Outcome measures
| Measure |
Blosozumab Formulation A
n=14 Participants
Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Blosozumab Formulation B
n=8 Participants
Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation A
Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation B
Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B
|
7880 pmol*hours per mL
Geometric Coefficient of Variation 83
|
6400 pmol*hours per mL
Geometric Coefficient of Variation 110
|
—
|
—
|
Adverse Events
Blosozumab Formulation A
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Blosozumab Formulation B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Formulation A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Formulation B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blosozumab Formulation A
n=14 participants at risk
Blosozumab Formulation A administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Blosozumab Formulation B
n=8 participants at risk
Blosozumab Formulation B administered as a 180 mg loading dose SC in Week 1 followed by 90 mg SC QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation A
n=3 participants at risk
Placebo matching Blosozumab Formulation A administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
Placebo Formulation B
n=3 participants at risk
Placebo matching Blosozumab Formulation B administered as a loading dose SC in Week 1 followed by a SC injection QW for 5 weeks. Participants were followed for 7 weeks after the last dose.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Gastrointestinal disorders
Toothache
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
General disorders
Injection site bruising
|
42.9%
6/14 • Number of events 11 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
37.5%
3/8 • Number of events 5 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
33.3%
1/3 • Number of events 3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
General disorders
Injection site discolouration
|
14.3%
2/14 • Number of events 6 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
General disorders
Injection site erythema
|
78.6%
11/14 • Number of events 35 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
62.5%
5/8 • Number of events 11 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
66.7%
2/3 • Number of events 4 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
General disorders
Injection site induration
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
General disorders
Injection site pruritus
|
35.7%
5/14 • Number of events 9 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
12.5%
1/8 • Number of events 2 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
General disorders
Injection site swelling
|
42.9%
6/14 • Number of events 12 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
33.3%
1/3 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
12.5%
1/8 • Number of events 2 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.1%
1/14 • Number of events 2 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
33.3%
1/3 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/8 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
0.00%
0/3 • Baseline through Day 85
Includes SAEs and all other non-serious AEs that met the frequency threshold regardless of causality. Non-serious AEs met criteria for stopping the study.
|
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