Trial Outcomes & Findings for A Study of LY2409021 in Participants With Different Levels of Kidney Function (NCT NCT01929109)
NCT ID: NCT01929109
Last Updated: 2018-10-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose
Results posted on
2018-10-29
Participant Flow
This study consisted of 5 groups: Group 1-4 (Normal Renal Function Control, Mild, Moderate and Severe Renal Impairment) and Group 5 \[End-stage Renal Disease (ESRD)\].
Participant milestones
| Measure |
LY2409021 Control
Healthy participants received a single 80 milligram (mg) dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Mild Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Moderate Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Severe Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 End Stage Renal Disease
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1(Dialysis) of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 (Non Dialysis) of the study.
|
|---|---|---|---|---|---|
|
Period 1 (All Groups)
STARTED
|
14
|
8
|
9
|
8
|
8
|
|
Period 1 (All Groups)
COMPLETED
|
14
|
8
|
8
|
8
|
8
|
|
Period 1 (All Groups)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
|
Period 2 (End Stage Renal Disease Only)
STARTED
|
0
|
0
|
0
|
0
|
8
|
|
Period 2 (End Stage Renal Disease Only)
COMPLETED
|
0
|
0
|
0
|
0
|
8
|
|
Period 2 (End Stage Renal Disease Only)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
LY2409021 Control
Healthy participants received a single 80 milligram (mg) dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Mild Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Moderate Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Severe Renal Impairment
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 End Stage Renal Disease
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1(Dialysis) of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 (Non Dialysis) of the study.
|
|---|---|---|---|---|---|
|
Period 1 (All Groups)
Deviation from protocol
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of LY2409021 in Participants With Different Levels of Kidney Function
Baseline characteristics by cohort
| Measure |
LY2409021 Control
n=14 Participants
Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Mild Renal Impairment
n=8 Participants
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Moderate Renal Impairment
n=8 Participants
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Severe Renal Impairment
n=8 Participants
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 End Stage Renal Disease
n=8 Participants
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
68.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
52.0 years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
59.2 years
STANDARD_DEVIATION 11.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=10 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
|
0 Participants
n=10 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
|
0 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
45 Participants
n=10 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
|
0 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Type 2 Diabetes Mellitus (T2DM) status
Yes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Type 2 Diabetes Mellitus (T2DM) status
No
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
45 Participants
n=10 Participants
|
|
Creatinine clearance (CLcr)
|
112.686 mL/min
STANDARD_DEVIATION 16.152 • n=5 Participants
|
72.850 mL/min
STANDARD_DEVIATION 6.512 • n=7 Participants
|
45.844 mL/min
STANDARD_DEVIATION 10.121 • n=5 Participants
|
21.951 mL/min
STANDARD_DEVIATION 3.952 • n=4 Participants
|
13.763 mL/min
STANDARD_DEVIATION 4.159 • n=21 Participants
|
61.149 mL/min
STANDARD_DEVIATION 40.837 • n=10 Participants
|
|
Estimated Glomerular Filtration Rate (eGRF)
|
91.272 mL/min/1.73m²
STANDARD_DEVIATION 17.122 • n=5 Participants
|
68.107 mL/min/1.73m²
STANDARD_DEVIATION 15.876 • n=7 Participants
|
40.448 mL/min/1.73m²
STANDARD_DEVIATION 12.793 • n=5 Participants
|
17.565 mL/min/1.73m²
STANDARD_DEVIATION 7.200 • n=4 Participants
|
8.249 mL/min/1.73m²
STANDARD_DEVIATION 1.918 • n=21 Participants
|
51.147 mL/min/1.73m²
STANDARD_DEVIATION 35.467 • n=10 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdosePopulation: All participants in Groups 1-4 who received at least 1 dose of study drug and had evaluable PK data, excluding one participant (discontinued for a protocol violation). No efficacy or safety data for this participant are included in results.
Outcome measures
| Measure |
LY2409021 Control
n=14 Participants
Healthy participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Mild Renal Impairment
n=8 Participants
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Moderate Renal Impairment
n=8 Participants
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Severe Renal Impairment
n=8 Participants
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021
|
2460 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
2320 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
2190 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
2080 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdosePopulation: All participants in Groups 1-4 who received at least 1 dose of study drug and had evaluable PK data, excluding one participant (discontinued for a protocol violation). No efficacy or safety data for this participant are included in results.
Outcome measures
| Measure |
LY2409021 Control
n=14 Participants
Healthy participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Mild Renal Impairment
n=8 Participants
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Moderate Renal Impairment
n=8 Participants
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Severe Renal Impairment
n=8 Participants
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021
|
181000 Nanogram x hour per milliliter(ng•h/mL)
Geometric Coefficient of Variation 40
|
179000 Nanogram x hour per milliliter(ng•h/mL)
Geometric Coefficient of Variation 40
|
184000 Nanogram x hour per milliliter(ng•h/mL)
Geometric Coefficient of Variation 56
|
188000 Nanogram x hour per milliliter(ng•h/mL)
Geometric Coefficient of Variation 24
|
SECONDARY outcome
Timeframe: Period 1 (Dialysis) and Period 2 (Non Dialysis) Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdosePopulation: All participants in Group 5 who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
LY2409021 Control
n=8 Participants
Healthy participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Mild Renal Impairment
n=8 Participants
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Moderate Renal Impairment
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Severe Renal Impairment
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 in Participants With End Stage Renal Disease (ESRD) Before and After Dialysis
|
2120 ng/mL
Geometric Coefficient of Variation 72
|
2010 ng/mL
Geometric Coefficient of Variation 37
|
—
|
—
|
SECONDARY outcome
Timeframe: Period 1 (Dialysis) and Period 2 (Non Dialysis)- Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdosePopulation: All participants in Group 5 who received at least 1 dose of study drug and had evaluable AUC data.
Outcome measures
| Measure |
LY2409021 Control
n=8 Participants
Healthy participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Mild Renal Impairment
n=8 Participants
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Moderate Renal Impairment
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
LY2409021 Severe Renal Impairment
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) (0-∞) of LY2409021 In Participants With ESRD Before and After Dialysis
|
119000 ng•h/mL
Geometric Coefficient of Variation 51
|
120000 ng•h/mL
Geometric Coefficient of Variation 37
|
—
|
—
|
Adverse Events
LY2409021 Control
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LY2409021 Mild Renal Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY2409021 Moderate Renal Impairment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY2409021 Severe Renal Impairment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
LY2409021 End Stage Renal Disease
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2409021 Control
n=14 participants at risk
Healthy participants received a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Mild Renal Impairment
n=8 participants at risk
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Moderate Renal Impairment
n=8 participants at risk
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 Severe Renal Impairment
n=8 participants at risk
Participants will receive a single 80 mg dose of LY2409021 orally on Day 1 of the study.
|
LY2409021 End Stage Renal Disease
n=8 participants at risk
Participants received a single 80 mg dose of LY2409021 orally on Day 1 of Period 1 of the study and a single 80 mg dose of LY2409021 orally on Day 1 of Period 2 of the study.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Eye disorders
Eye irritation
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 2
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
25.0%
2/8 • Number of events 2
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 2
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 2
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
25.0%
2/8 • Number of events 2
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
General disorders
Fatigue
|
21.4%
3/14 • Number of events 3
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
General disorders
Oedema peripheral
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.1%
1/14 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 1
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
12.5%
1/8 • Number of events 2
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
0.00%
0/8
One participant discontinued due to a protocol violation. No efficacy or safety data in results for this participant.
|
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: LTE60