Trial Outcomes & Findings for A Study of LY2928057 in Hemodialysis Participants (NCT NCT01991483)
NCT ID: NCT01991483
Last Updated: 2019-03-07
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
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Baseline to Study Completion (up to Day 137)
Results posted on
2019-03-07
Participant Flow
This study included three parts. Part A was dose escalation (placebo, 300, 600, or 1,000 milligrams \[mg\] LY2928057). Part B was dose expansion (placebo or 1000 mg LY2928057). Part C was optional, based on predefined pharmacodynamics criteria. Part C was not executed.
Participant milestones
| Measure |
Placebo
Placebo administered intravenously (IV) once every two weeks (Q2W) for six weeks (three doses).
|
300 mg LY2928057
300 milligrams (mg) LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Dose Level: Placebo
STARTED
|
7
|
0
|
0
|
0
|
|
Dose Level: Placebo
Received at Least One Dose of Study Drug
|
7
|
0
|
0
|
0
|
|
Dose Level: Placebo
COMPLETED
|
7
|
0
|
0
|
0
|
|
Dose Level: Placebo
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 300 mg
STARTED
|
0
|
6
|
0
|
0
|
|
Dose Level 300 mg
Received at Least One Dose of Study Drug
|
0
|
6
|
0
|
0
|
|
Dose Level 300 mg
COMPLETED
|
0
|
6
|
0
|
0
|
|
Dose Level 300 mg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 600 mg
STARTED
|
0
|
0
|
11
|
0
|
|
Dose Level 600 mg
Receive at Least One Dose of Study Drug
|
0
|
0
|
11
|
0
|
|
Dose Level 600 mg
COMPLETED
|
0
|
0
|
9
|
0
|
|
Dose Level 600 mg
NOT COMPLETED
|
0
|
0
|
2
|
0
|
|
Dose Level 1000 mg
STARTED
|
0
|
0
|
0
|
4
|
|
Dose Level 1000 mg
Received at Least One Dose of Study Drug
|
0
|
0
|
0
|
4
|
|
Dose Level 1000 mg
COMPLETED
|
0
|
0
|
0
|
3
|
|
Dose Level 1000 mg
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo administered intravenously (IV) once every two weeks (Q2W) for six weeks (three doses).
|
300 mg LY2928057
300 milligrams (mg) LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Dose Level 600 mg
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Dose Level 600 mg
Physician Decision
|
0
|
0
|
1
|
0
|
|
Dose Level 1000 mg
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY2928057 in Hemodialysis Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
53.6 years
STANDARD_DEVIATION 8.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 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
|
|
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
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Study Completion (up to Day 137)Population: All participants who received at least one 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 |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
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
|
PRIMARY outcome
Timeframe: Baseline, Day 42Population: All participants who received three doses of study drug, had pharmacodynamics assessment at Week 6, and/or received anti-anemic rescue therapy per protocol, regardless of whether they completed treatment.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=5 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=9 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=2 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin at 6 Week Endpoint
|
-1.674 grams per deciliter (g/dL)
Standard Deviation 0.5535
|
-1.739 grams per deciliter (g/dL)
Standard Deviation 0.5261
|
-0.906 grams per deciliter (g/dL)
Standard Deviation 0.4577
|
-1.623 grams per deciliter (g/dL)
Standard Deviation 1.0469
|
SECONDARY outcome
Timeframe: Baseline through 6 WeeksPopulation: All participants who received at least one dose of study drug had evaluable hemoglobin values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Hemoglobin
|
1.294 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.320
|
1.677 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.701
|
1.162 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.367
|
1.348 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.563
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: All participants who received at least one dose of study drug and had evaluable serum Fe values at baseline and post-baseline.
Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations relative to baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations Relative to Baseline
|
0.99 Ratio
Geometric Coefficient of Variation 16
|
1.57 Ratio
Geometric Coefficient of Variation 32
|
1.59 Ratio
Geometric Coefficient of Variation 69
|
2.36 Ratio
Geometric Coefficient of Variation 44
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All participants who received at least one dose of study drug and had evaluable TSat values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=9 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat)
|
0.2117 percentage change in TSat
Standard Deviation 0.1120
|
0.5250 percentage change in TSat
Standard Deviation 0.0873
|
0.5000 percentage change in TSat
Standard Deviation 0.1550
|
0.4375 percentage change in TSat
Standard Deviation 0.0624
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All participants who received at least one dose of study drug had evaluable CHr values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr)
|
1.93 picograms (pg)
Standard Deviation 0.45
|
3.00 picograms (pg)
Standard Deviation 1.18
|
3.60 picograms (pg)
Standard Deviation 2.31
|
3.20 picograms (pg)
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All participants who received at least one dose of study drug and had evaluable reticulocyte values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=2 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Reticulocyte Count
|
49 gigaparticles per liter (GI/L)
Standard Deviation 37.6
|
72.17 gigaparticles per liter (GI/L)
Standard Deviation 29.21
|
40.73 gigaparticles per liter (GI/L)
Standard Deviation 13.81
|
74.25 gigaparticles per liter (GI/L)
Standard Deviation 78.73
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All participants who received at least one dose of study drug and had evaluable RBC values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Red Blood Cell (RBC) Count
|
0.686 tera per liter (TI/L)
Standard Deviation 0.135
|
0.900 tera per liter (TI/L)
Standard Deviation 0.341
|
0.627 tera per liter (TI/L)
Standard Deviation 0.228
|
0.725 tera per liter (TI/L)
Standard Deviation 0.299
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All participants who received at least one dose of study drug and had evaluable MCV values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Volume (MCV)
|
5.9 femtoliters (fL)
Standard Deviation 4.6
|
5.2 femtoliters (fL)
Standard Deviation 1.9
|
6.2 femtoliters (fL)
Standard Deviation 1.7
|
7.0 femtoliters (fL)
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All participants who received at least one dose of study drug and had evaluable MCH values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin (MCH)
|
0.107 femtomoles of iron (fmol[Fe])
Standard Deviation 0.029
|
0.105 femtomoles of iron (fmol[Fe])
Standard Deviation 0.027
|
0.091 femtomoles of iron (fmol[Fe])
Standard Deviation 0.050
|
0.080 femtomoles of iron (fmol[Fe])
Standard Deviation 0.034
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All participants who received at least one dose of study drug and had evaluable MCHC values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin Concentration (MCHC)
|
1.4 millimoles/liter of iron (mml/L-Fe)
Standard Deviation 0.5
|
1.2 millimoles/liter of iron (mml/L-Fe)
Standard Deviation 0.4
|
1.6 millimoles/liter of iron (mml/L-Fe)
Standard Deviation 0.7
|
1.5 millimoles/liter of iron (mml/L-Fe)
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline through 6 weeksPopulation: All participants who received at least one dose of study drug and had evaluable ferritin values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacodynamics (PD): Maximum Change in Ferritin
|
269.21 micrograms/liter (ug/L)
Standard Deviation 112.17
|
230.28 micrograms/liter (ug/L)
Standard Deviation 80.08
|
196.46 micrograms/liter (ug/L)
Standard Deviation 90.90
|
146.65 micrograms/liter (ug/L)
Standard Deviation 48.05
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdose;Population: All participants who received at least one dose of LY2928057 and had evaluable plasma values.
Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2 days (d), 4d, 7d, 9d, 11d postdose; Time frame for Cycle 3: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d, 14d postdose
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=11 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=4 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2928057
Cycle 3 (Third dose)
|
62.8 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 21
|
177 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 34
|
358 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation NA
Coefficient of variation was not produced as there are only 2 participants.
|
—
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2928057
Cycle 1 (First dose)
|
67.3 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 25
|
274 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 104
|
312 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 21
|
—
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2928057
Cycle 2 (Second dose)
|
70.0 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 21
|
213 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 49
|
397 micrograms per milliliter (µg/mL)
Geometric Coefficient of Variation 30
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdosePopulation: All participants who received at least one dose of LY2928057 and had evaluable plasma values.
Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d postdose; Time frame for Cycle 3: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d, 14d postdose;
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=11 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=4 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve From Time Zero to Infinity (AUC[0-inf]) of LY2928057
Cycle 1 (First dose)
|
1560 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation 39
|
7340 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation 33
|
11200 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation 24
|
—
|
|
Pharmacokinetics: Area Under the Concentration Curve From Time Zero to Infinity (AUC[0-inf]) of LY2928057
Cycle 2 (Second dose)
|
1640 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation 42
|
6970 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation 40
|
16100 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation 31
|
—
|
|
Pharmacokinetics: Area Under the Concentration Curve From Time Zero to Infinity (AUC[0-inf]) of LY2928057
Cycle 3 (Third dose)
|
1520 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation 40
|
6520 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation 25
|
12000 micrograms x hours/milliliter(µg*h/mL)
Geometric Coefficient of Variation NA
Coefficient of variation was not produced as there are only 2 participants.
|
—
|
SECONDARY outcome
Timeframe: Baseline through 84 daysPopulation: All participants who received at least one dose of study drug and had evaluable antibody values at baseline and post-baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 Participants
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 Participants
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Number of Participants With Anti-LY2928057 Antibodies
|
1 participants
|
4 participants
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Cycle 1: Predose, end of infusion, 2hours, 4h, 2d, 4d, 7d, 9d, 11d postdosePopulation: All participants who received 300 mg LY2928057 or 600 mg LY2928057 during dialysis and non-dialysis day and had evaluable plasma values. Data were not collected in the 1000 mg LY2928057 arm.
Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d postdose; Dialysis did not occur in cycle 1.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=11 Participants
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From 0 to 336 Hours AUC(0-336) During and Outside Dialysis
Cycle 1 (First dose, no dialysis)
|
1550 hr*ng/mL
Geometric Coefficient of Variation 39
|
7320 hr*ng/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From 0 to 336 Hours AUC(0-336) During and Outside Dialysis
Cycle 2 (Second dose during dialysis)
|
1630 hr*ng/mL
Geometric Coefficient of Variation 42
|
6940 hr*ng/mL
Geometric Coefficient of Variation 40
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
300 mg LY2928057
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
600 mg LY2928057
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
1000 mg LY2928057
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=7 participants at risk
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 participants at risk
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 participants at risk
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 participants at risk
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/11
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Vascular disorders
Hypertension
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Placebo administered IV Q2W for six weeks (three doses).
|
300 mg LY2928057
n=6 participants at risk
300 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
600 mg LY2928057
n=11 participants at risk
600 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
1000 mg LY2928057
n=4 participants at risk
1000 mg LY2928057 administered IV Q2W for six weeks (three doses).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
71.4%
5/7 • Number of events 5
|
33.3%
2/6 • Number of events 2
|
27.3%
3/11 • Number of events 3
|
50.0%
2/4 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
General disorders
Chest pain
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/11
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Infections and infestations
Tooth abscess
|
14.3%
1/7 • Number of events 2
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7
|
16.7%
1/6 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Investigations
Hepatic enzyme increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
14.3%
1/7 • Number of events 2
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/11
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Papule
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/11
|
0.00%
0/4
|
|
Vascular disorders
Hypotension
|
0.00%
0/7
|
0.00%
0/6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
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