Trial Outcomes & Findings for A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis (NCT NCT02144285)
NCT ID: NCT02144285
Last Updated: 2019-01-22
Results Overview
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Baseline through end of study (Day 85)
Results posted on
2019-01-22
Participant Flow
Participant milestones
| Measure |
Placebo (Part A)
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
|
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
|
LY IV 150mg(Part B)
Single dose of LY3113593 administered IV at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
2
|
6
|
|
Overall Study
Received At Least One Dose of Study Drug
|
14
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
2
|
6
|
|
Overall Study
COMPLETED
|
14
|
6
|
6
|
6
|
5
|
6
|
6
|
6
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo (Part A)
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg.
|
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
|
LY IV 150mg(Part B)
Single dose of LY3113593 administered IV at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
All enrolled participants Age data as per Part in trial.
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=14 Participants
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 Participants
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=6 Participants
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 50 mg.
|
LY IV 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
Placebo IV (Part B)
n=2 Participants
Single dose of placebo matching LY3113593 administered IV.
|
LY IV 150mg (Part B)
n=6 Participants
Single dose of LY3113593 administered IV at 150 mg.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Part A
|
37.8 years
STANDARD_DEVIATION 10.69 • n=14 Participants • All enrolled participants Age data as per Part in trial.
|
45.0 years
STANDARD_DEVIATION 7.40 • n=6 Participants • All enrolled participants Age data as per Part in trial.
|
31.0 years
STANDARD_DEVIATION 5.22 • n=6 Participants • All enrolled participants Age data as per Part in trial.
|
30.7 years
STANDARD_DEVIATION 4.41 • n=6 Participants • All enrolled participants Age data as per Part in trial.
|
41.5 years
STANDARD_DEVIATION 21.00 • n=6 Participants • All enrolled participants Age data as per Part in trial.
|
46.3 years
STANDARD_DEVIATION 8.89 • n=6 Participants • All enrolled participants Age data as per Part in trial.
|
38.3 years
STANDARD_DEVIATION 7.55 • n=6 Participants • All enrolled participants Age data as per Part in trial.
|
43.7 years
STANDARD_DEVIATION 13.05 • n=6 Participants • All enrolled participants Age data as per Part in trial.
|
—
|
—
|
39.1 years
STANDARD_DEVIATION 11.49 • n=56 Participants • All enrolled participants Age data as per Part in trial.
|
|
Age, Continuous
Part B
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
38.5 years
STANDARD_DEVIATION 13.44 • n=2 Participants • All enrolled participants Age data as per Part in trial.
|
51.7 years
STANDARD_DEVIATION 5.85 • n=6 Participants • All enrolled participants Age data as per Part in trial.
|
48.4 years
STANDARD_DEVIATION 9.35 • n=8 Participants • All enrolled participants Age data as per Part in trial.
|
|
Sex: Female, Male
Female
|
1 Participants
n=14 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=6 Participants
|
9 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=14 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=6 Participants
|
55 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
13 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=14 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
51 Participants
n=64 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=14 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
12 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=14 Participants
|
1 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
22 Participants
n=64 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=14 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
28 Participants
n=64 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=14 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
64 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Baseline through end of study (Day 85)Population: All enrolled participants who received at least one dose of study drug.
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo IV (Part B)
n=2 Participants
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
n=6 Participants
Single dose of LY3113593 administered IV.
|
Placebo (Part A)
n=14 Participants
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 Participants
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=6 Participants
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 50 mg
|
LY IV 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85Population: All enrolled participants who received at least one dose of LY3113593 study drug.
Outcome measures
| Measure |
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
Single dose of LY3113593 administered IV.
|
Placebo (Part A)
n=6 Participants
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 Participants
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=6 Participants
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 50 mg
|
LY IV 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593
|
—
|
—
|
559 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
2070 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
6330 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
20000 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
60800 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
170000 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
11300 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
38000 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85Population: All enrolled participants who received at least one dose of LY3113593 study drug.
Outcome measures
| Measure |
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
Single dose of LY3113593 administered IV.
|
Placebo (Part A)
n=6 Participants
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 Participants
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=6 Participants
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 50 mg
|
LY IV 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593
|
—
|
—
|
55700 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
280000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 14
|
1100000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 9
|
5240000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 17
|
17000000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
38300000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 17
|
7640000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
8270000 nanograms*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85Population: All enrolled participants who received at least one dose of 150mg LY3113593 study drug.
Outcome measures
| Measure |
Placebo IV (Part B)
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
Single dose of LY3113593 administered IV.
|
Placebo (Part A)
n=6 Participants
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 Participants
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
Single dose of LY3113593 administered IV at 50 mg
|
LY IV 150mg (Part A)
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios
|
—
|
—
|
7640000 ng*h/mL
Geometric Coefficient of Variation 37
|
17000000 ng*h/mL
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 85Population: All enrolled participants who received at least one dose of study drug and had baseline and post baseline iron profile data.
Outcome measures
| Measure |
Placebo IV (Part B)
n=2 Participants
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
n=6 Participants
Single dose of LY3113593 administered IV.
|
Placebo (Part A)
n=12 Participants
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 Participants
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=5 Participants
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 50 mg
|
LY IV 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=5 Participants
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593
|
3.3 micromoles per liter (μmol/L)
Standard Deviation 1.98
|
7.92 micromoles per liter (μmol/L)
Standard Deviation 6.68
|
6.78 micromoles per liter (μmol/L)
Standard Deviation 12.5
|
4.12 micromoles per liter (μmol/L)
Standard Deviation 5.49
|
9.46 micromoles per liter (μmol/L)
Standard Deviation 11.6
|
8.38 micromoles per liter (μmol/L)
Standard Deviation 5.22
|
10.23 micromoles per liter (μmol/L)
Standard Deviation 10.8
|
13.5 micromoles per liter (μmol/L)
Standard Deviation 5.68
|
7.9 micromoles per liter (μmol/L)
Standard Deviation 9.67
|
6.97 micromoles per liter (μmol/L)
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Baseline, Day 85Population: All enrolled participants who received at least one dose of study drug and had baseline and post baseline Tsat profile data.
Outcome measures
| Measure |
Placebo IV (Part B)
n=2 Participants
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
n=6 Participants
Single dose of LY3113593 administered IV.
|
Placebo (Part A)
n=12 Participants
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 Participants
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=6 Participants
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 50 mg
|
LY IV 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=5 Participants
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593
|
-0.50 percentage of change
Standard Deviation 14.90
|
18.30 percentage of change
Standard Deviation 18.10
|
11.00 percentage of change
Standard Deviation 22.00
|
6.80 percentage of change
Standard Deviation 10.00
|
14.80 percentage of change
Standard Deviation 18.00
|
15.70 percentage of change
Standard Deviation 11.00
|
12.80 percentage of change
Standard Deviation 23.00
|
21.00 percentage of change
Standard Deviation 8.60
|
07.80 percentage of change
Standard Deviation 6.65
|
17.00 percentage of change
Standard Deviation 16.00
|
SECONDARY outcome
Timeframe: Baseline, Day 85Population: All enrolled participants who received at least one dose of study drug and had baseline and post baseline Hb profile data.
Outcome measures
| Measure |
Placebo IV (Part B)
n=2 Participants
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
n=6 Participants
Single dose of LY3113593 administered IV.
|
Placebo (Part A)
n=14 Participants
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 Participants
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=6 Participants
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=5 Participants
Single dose of LY3113593 administered IV at 50 mg
|
LY IV 150mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=6 Participants
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=5 Participants
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593
|
0.375 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.361
|
0.568 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.444
|
0.269 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.455
|
0.425 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.363
|
0.123 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.486
|
0.205 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.468
|
0.780 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.38
|
0.508 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.65
|
0.165 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.796
|
0.217 millimoles per liter of iron (mml/L-Fe)
Standard Deviation 0.306
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY IV 1.5mg (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY IV 5mg (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY IV 15mg (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY IV 50mg (Part A)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
LY IV 150mg (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY IV 400mg (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LY SC 150mg (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo IV (Part B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LY IV (Part B)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=14 participants at risk
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 participants at risk
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered IV at 50 mg.
|
LY IV 150mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
Placebo IV (Part B)
n=2 participants at risk
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
n=6 participants at risk
Single dose of LY3113593 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
Other adverse events
| Measure |
Placebo (Part A)
n=14 participants at risk
Single dose of placebo matching LY3113593.
|
LY IV 1.5mg (Part A)
n=6 participants at risk
Single dose of LY3113593 (LY) administered IV at a 1.5 milligrams (mg).
|
LY IV 5mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered intravenous (IV) at 5 mg.
|
LY IV 15mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered IV at 15 mg.
|
LY IV 50mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered IV at 50 mg.
|
LY IV 150mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered IV at 150 mg.
|
LY IV 400mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered IV at 400 mg.
|
LY SC 150mg (Part A)
n=6 participants at risk
Single dose of LY3113593 administered subcutaneously (SC) at 150 mg.
|
Placebo IV (Part B)
n=2 participants at risk
Single dose of placebo matching LY3113593 administered IV.
|
LY IV (Part B)
n=6 participants at risk
Single dose of LY3113593 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/14
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/14
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
General disorders
Influenza like illness
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
|
General disorders
Infusion site pain
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
General disorders
Pyrexia
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Immune system disorders
Food allergy
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Immune system disorders
Seasonal allergy
|
7.1%
1/14 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Infections and infestations
Rhinitis
|
7.1%
1/14 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
50.0%
3/6 • Number of events 3
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
33.3%
2/6 • Number of events 2
All enrolled participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Investigations
Electrocardiogram abnormal
|
7.1%
1/14 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Investigations
Weight decreased
|
0.00%
0/14
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/14
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
16.7%
1/6 • Number of events 1
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
0.00%
0/2
All enrolled participants.
|
0.00%
0/6
All enrolled participants.
|
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