Trial Outcomes & Findings for A Study of LY3113593 in Participants With Chronic Kidney Disease (NCT NCT02604160)
NCT ID: NCT02604160
Last Updated: 2019-03-21
Results Overview
A summary of other non-serious adverse events (AEs) and all serious adverse events, regardless of causality, is located in the reported adverse events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
Baseline through Day 29
Results posted on
2019-03-21
Participant Flow
In Part A of the study, a dose stopping criterion was met leading to early conclusion of the study.
Participant milestones
| Measure |
Placebo
0.9% saline, administered by intravenous (IV) infusion once every four weeks (Q4W) (Day 1 and 29) in part A.
|
LY3113593
50 milligram (mg) of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
|
Overall Study
Received at Least One Dose of Study Drug
|
2
|
5
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
0.9% saline, administered by intravenous (IV) infusion once every four weeks (Q4W) (Day 1 and 29) in part A.
|
LY3113593
50 milligram (mg) of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study of LY3113593 in Participants With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
0.9% saline, administered by intravenous (IV) infusion once every four weeks (Q4W) (Day 1 and 29) in part A.
|
LY3113593
n=5 Participants
50 milligram (mg) of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 29Population: All participants who received at least one dose of study drug or placebo, and have at least one post dose safety assessment.
A summary of other non-serious adverse events (AEs) and all serious adverse events, regardless of causality, is located in the reported adverse events section.
Outcome measures
| Measure |
Placebo
n=2 Participants
0.9% saline of placebo administered by IV infusion Q4W (Day 1 and 29) in part A.
|
LY3113593
n=5 Participants
50 mg of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
|
|---|---|---|
|
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
|
1 Participants
|
SECONDARY outcome
Timeframe: Predose; 0.5, 4 hours post-dosePopulation: All participants who received at least one dose of study drug and have evaluable PK data. PK was not assessed in placebo.
Outcome measures
| Measure |
Placebo
n=5 Participants
0.9% saline of placebo administered by IV infusion Q4W (Day 1 and 29) in part A.
|
LY3113593
50 mg of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593
Day 1
|
11934 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
—
|
|
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593
Day 29
|
13567 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
—
|
SECONDARY outcome
Timeframe: Predose; 0.5, 4 hours post-dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data. PK was not assessed in placebo.
Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W)
Outcome measures
| Measure |
Placebo
n=5 Participants
0.9% saline of placebo administered by IV infusion Q4W (Day 1 and 29) in part A.
|
LY3113593
50 mg of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time (AUCτ)
Day 1
|
2281 microgram.hour/milliliter (ug*h/mL)
Geometric Coefficient of Variation 36
|
—
|
|
PK: Area Under the Concentration Versus Time (AUCτ)
Day 29
|
2707 microgram.hour/milliliter (ug*h/mL)
Geometric Coefficient of Variation 36
|
—
|
SECONDARY outcome
Timeframe: Predose; 0.5, 4 hours post-dosePopulation: Zero participants were analyzed; data not collected. Change from baseline to week 8 in Hemoglobin (Hb) was not assessed since study was concluded early at part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1: Predose; Day 15, 29, 57, 85 and 113Population: All participants who received at least one dose of study drug, and have at least one post dose safety assessment.
Participants with a detection of anti-LY3113593 antibodies at baseline and post-baseline time point at the following levels of 1:20, 1:40 or 1:80 titer.
Outcome measures
| Measure |
Placebo
n=2 Participants
0.9% saline of placebo administered by IV infusion Q4W (Day 1 and 29) in part A.
|
LY3113593
n=5 Participants
50 mg of LY3113593 administered by IV infusion Q4W (Day 1 and 29) in part A.
|
|---|---|---|
|
Number of Participants With Anti-LY3113593 Antibodies Detection
Day 1 Predose; 1:80 Titer
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-LY3113593 Antibodies Detection
Day 15 ± 2 days; 1:20 Titer
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-LY3113593 Antibodies Detection
Day 29 ± 2 days; 1:80 Titer
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-LY3113593 Antibodies Detection
Day 57 ± 2 days; 1:40 Titer
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-LY3113593 Antibodies Detection
Day 85 ± 2 days; 1:40 Titer
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-LY3113593 Antibodies Detection
Day 113; ± 2 days; 1:40 Titer
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY3113593
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=2 participants at risk
0.9% saline, administered by slow IV infusion Q4W (Day 1 and 29) in part A.
|
LY3113593
n=5 participants at risk
50 mg of LY3113593 administered by slow IV infusion Q4W (Day 1 and 29) in part A.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=2 participants at risk
0.9% saline, administered by slow IV infusion Q4W (Day 1 and 29) in part A.
|
LY3113593
n=5 participants at risk
50 mg of LY3113593 administered by slow IV infusion Q4W (Day 1 and 29) in part A.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
2/2 • Number of events 2
|
80.0%
4/5 • Number of events 4
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Influenza
|
50.0%
1/2 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2
|
20.0%
1/5 • 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