Trial Outcomes & Findings for A Study of LY3084077 in Healthy Participants (NCT NCT01846702)

NCT ID: NCT01846702

Last Updated: 2018-07-30

Results Overview

An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

43 participants

Primary outcome timeframe

Pre-dose, Up to Day 190

Results posted on

2018-07-30

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo Cohort 1
Single dose of placebo matching LY3084077 administered subcutaneously (SC).
LY3084077 Cohort 2
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
3 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 4
10 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 5
30 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 6
100 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 7
150 mg single dose of LY3084077 administered SC
Overall Study
STARTED
6
6
7
6
6
6
6
Overall Study
Received at Least 1 Dose of Study Drug
6
6
6
6
6
6
6
Overall Study
COMPLETED
6
6
6
6
6
6
6
Overall Study
NOT COMPLETED
0
0
1
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of LY3084077 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered subcutaneously (SC).
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 Participants
3 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3074077 administered SC.
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3074077 administered SC.
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3074077 administered SC.
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3074077 administered SC.
Total
n=42 Participants
Total of all reporting groups
Age, Continuous
35.7 years
STANDARD_DEVIATION 14 • n=5 Participants
30.7 years
STANDARD_DEVIATION 13.2 • n=7 Participants
34.5 years
STANDARD_DEVIATION 11.2 • n=5 Participants
32.7 years
STANDARD_DEVIATION 7.4 • n=4 Participants
40.7 years
STANDARD_DEVIATION 12.6 • n=21 Participants
30.5 years
STANDARD_DEVIATION 5.0 • n=10 Participants
36.3 years
STANDARD_DEVIATION 4.8 • n=115 Participants
34.4 years
STANDARD_DEVIATION 10.2 • n=24 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
2 Participants
n=24 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
6 Participants
n=4 Participants
5 Participants
n=21 Participants
6 Participants
n=10 Participants
6 Participants
n=115 Participants
40 Participants
n=24 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
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
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
6 Participants
n=4 Participants
6 Participants
n=21 Participants
6 Participants
n=10 Participants
6 Participants
n=115 Participants
42 Participants
n=24 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
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 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
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Asian
6 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
4 Participants
n=4 Participants
6 Participants
n=21 Participants
6 Participants
n=10 Participants
6 Participants
n=115 Participants
40 Participants
n=24 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
0 Participants
n=115 Participants
0 Participants
n=24 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
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
2 Participants
n=24 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
0 Participants
n=115 Participants
0 Participants
n=24 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
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Region of Enrollment
Singapore
6 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
6 Participants
n=4 Participants
6 Participants
n=21 Participants
6 Participants
n=10 Participants
6 Participants
n=115 Participants
42 Participants
n=24 Participants

PRIMARY outcome

Timeframe: Pre-dose, Up to Day 190

Population: All randomized participants who received at least one dose of study drug.

An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
1 participants
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants

SECONDARY outcome

Timeframe: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=2 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=5 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=4 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077
NA microgram*hour/milliliter (μg•hr/mL)
Geometric Coefficient of Variation NA
Cohort 1 was not calculable due to samples from placebo treated participants were not analyzed.
NA microgram*hour/milliliter (μg•hr/mL)
Geometric Coefficient of Variation NA
Cohort 2 was not calculable due to concentration level was below quantification limits.
8.74 microgram*hour/milliliter (μg•hr/mL)
Geometric Coefficient of Variation 13
17.9 microgram*hour/milliliter (μg•hr/mL)
Geometric Coefficient of Variation 42
61.8 microgram*hour/milliliter (μg•hr/mL)
Geometric Coefficient of Variation 34
248 microgram*hour/milliliter (μg•hr/mL)
Geometric Coefficient of Variation 221
249 microgram*hour/milliliter (μg•hr/mL)
Geometric Coefficient of Variation 20

SECONDARY outcome

Timeframe: Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=4 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077
NA microgram/milliliter (μg/mL)
Geometric Coefficient of Variation NA
Cohort 1 was not calculable due to samples from placebo treated participants were not analyzed.
NA microgram/milliliter (μg/mL)
Geometric Coefficient of Variation NA
Cohort 2 was not calculable due to concentration level was below quantification limits.
0.0428 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 53
0.0745 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 24
0.188 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 78
1.14 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 79
1.23 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 48

SECONDARY outcome

Timeframe: Baseline, Up to Day 15

Population: All randomized participants who received at least one dose of study drug and had evaluable fasting triglycerides data.

Percent change=(measure at time t-measure at baseline)/measure at baseline\*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides
-23.7 percent
Standard Deviation 12.8
-13.7 percent
Standard Deviation 12.8
-35.3 percent
Standard Deviation 12.6
-30.4 percent
Standard Deviation 12.6
-23.8 percent
Standard Deviation 13.6
-2.50 percent
Standard Deviation 14.2
-43.7 percent
Standard Deviation 13.0

SECONDARY outcome

Timeframe: Baseline, Up to Day 15

Population: All randomized participants who received at least one dose of study drug and had evaluable fasting insulin data.

LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
PD: Change From Baseline in Fasting Insulin
-24.0 picomole/Liter (pmol/L)
Standard Error 8.23
-24.6 picomole/Liter (pmol/L)
Standard Error 8.55
-21.4 picomole/Liter (pmol/L)
Standard Error 8.41
4.90 picomole/Liter (pmol/L)
Standard Error 8.26
-28.4 picomole/Liter (pmol/L)
Standard Error 9.19
-11.9 picomole/Liter (pmol/L)
Standard Error 8.29
-26.6 picomole/Liter (pmol/L)
Standard Error 8.44

SECONDARY outcome

Timeframe: Baseline, Up to Day 15

Population: Zero participants had weight measured and therefore change from baseline in weight was not calculable across all arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 2

Population: All randomized participants who received at least one dose of study drug and had evaluable C-peptide AUC before and after a standard meal data.

LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal
-292 picomole*hour/Liter (pmol*h/L)
Standard Error 579
310 picomole*hour/Liter (pmol*h/L)
Standard Error 559
-157 picomole*hour/Liter (pmol*h/L)
Standard Error 579
1313 picomole*hour/Liter (pmol*h/L)
Standard Error 564
372 picomole*hour/Liter (pmol*h/L)
Standard Error 592
-192 picomole*hour/Liter (pmol*h/L)
Standard Error 564
973 picomole*hour/Liter (pmol*h/L)
Standard Error 568

SECONDARY outcome

Timeframe: Baseline, Day 2

Population: All randomized participants who received at least one dose of study drug and had evaluable incremental glucose AUC before and after a standard meal data.

LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal
-1.76 millomole*hour/Liter (mmol*h/L)
Standard Error 1.16
0.758 millomole*hour/Liter (mmol*h/L)
Standard Error 1.18
-0.202 millomole*hour/Liter (mmol*h/L)
Standard Error 1.14
-0.350 millomole*hour/Liter (mmol*h/L)
Standard Error 1.15
-2.14 millomole*hour/Liter (mmol*h/L)
Standard Error 1.13
-1.79 millomole*hour/Liter (mmol*h/L)
Standard Error 1.13
-1.82 millomole*hour/Liter (mmol*h/L)
Standard Error 1.15

SECONDARY outcome

Timeframe: Baseline, Up to Day 2

Population: All randomized participants who received at least one dose of study drug and have evaluable fasting glucagon data.

LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
PD: Change From Baseline to Day 2 in Fasting Glucagon
3.17 pmol/L
Standard Error 1.98
0.940 pmol/L
Standard Error 1.96
2.38 pmol/L
Standard Error 1.98
-0.514 pmol/L
Standard Error 1.95
4.15 pmol/L
Standard Error 1.96
1.01 pmol/L
Standard Error 1.99
1.52 pmol/L
Standard Error 1.96

SECONDARY outcome

Timeframe: Pre-dose, Up to Day 190

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and postbaseline antibody titers.

The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.

Outcome measures

Outcome measures
Measure
Placebo Cohort 1
n=6 Participants
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 Participants
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 Participants
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 Participants
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 Participants
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 Participants
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 Participants
150 mg single dose of LY3084077 administered SC
Number of Participants Developing Anti-LY3084077 Antibodies
0 participants
1 participants
0 participants
0 participants
0 participants
0 participants
0 participants

Adverse Events

Placebo Cohort 1

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

LY3084077 Cohort 2

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

LY3084077 Cohort 3

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

LY3084077 Cohort 4

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

LY3084077 Cohort 5

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

LY3084077 Cohort 6

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

LY3084077 Cohort 7

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo Cohort 1
n=6 participants at risk
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 participants at risk
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 participants at risk
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 participants at risk
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 participants at risk
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 participants at risk
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 participants at risk
150 mg single dose of LY3084077 administered SC
Gastrointestinal disorders
Gastritis
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure
Placebo Cohort 1
n=6 participants at risk
Single dose of placebo matching LY3084077 administered SC.
LY3084077 Cohort 2
n=6 participants at risk
1 mg single dose of LY3084077 administered SC.
LY3084077 Cohort 3
n=6 participants at risk
3 mg single dose of LY3084077 administered SC
LY3084077 Cohort 4
n=6 participants at risk
10 mg single dose of LY3084077 administered SC
LY3084077 Cohort 5
n=6 participants at risk
30 mg single dose of LY3084077 administered SC
LY3084077 Cohort 6
n=6 participants at risk
100 mg single dose of LY3084077 administered SC
LY3084077 Cohort 7
n=6 participants at risk
150 mg single dose of LY3084077 administered SC
General disorders
Thirst
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Infections and infestations
Dengue fever
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Infections and infestations
Influenza
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Infections and infestations
Upper respiratory tract infection
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications
Procedural site reaction
50.0%
3/6 • Number of events 3
All randomized participants who received at least one dose of study drug.
66.7%
4/6 • Number of events 6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
33.3%
2/6 • Number of events 2
All randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
33.3%
2/6 • Number of events 2
All randomized participants who received at least one dose of study drug.
66.7%
4/6 • Number of events 4
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders
Hypoglycaemia
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
33.3%
2/6 • Number of events 4
All randomized participants who received at least one dose of study drug.
Ear and labyrinth disorders
Hypoacusis
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Eye disorders
Eyelid pain
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Eye disorders
Lacrimation increased
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders
Abdominal distension
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
50.0%
3/6 • Number of events 3
All randomized participants who received at least one dose of study drug.
50.0%
3/6 • Number of events 3
All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders
Colitis
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders
Diarrhoea
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders
Nausea
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
50.0%
3/6 • Number of events 4
All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders
Vomiting
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
33.3%
2/6 • Number of events 2
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
General disorders
Catheter site erythema
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
General disorders
Catheter site haematoma
33.3%
2/6 • Number of events 2
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
33.3%
2/6 • Number of events 2
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
General disorders
Catheter site pain
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
General disorders
Early satiety
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
General disorders
Fatigue
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
General disorders
Feeling hot
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
33.3%
2/6 • Number of events 3
All randomized participants who received at least one dose of study drug.
General disorders
Injection site haematoma
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
General disorders
Injection site pain
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
General disorders
Pain
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
General disorders
Pyrexia
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Nervous system disorders
Dizziness
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Nervous system disorders
Headache
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
33.3%
2/6 • Number of events 3
All randomized participants who received at least one dose of study drug.
Nervous system disorders
Lethargy
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Nervous system disorders
Presyncope
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Psychiatric disorders
Anxiety
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Cough
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
50.0%
3/6 • Number of events 3
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Acne
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
33.3%
2/6 • Number of events 2
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.
16.7%
1/6 • Number of events 1
All randomized participants who received at least one dose of study drug.
0.00%
0/6
All randomized participants who received at least one dose of study drug.

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