Trial Outcomes & Findings for A Study of LY2922470 in Healthy Participants and Participants With Diabetes (NCT NCT01746017)
NCT ID: NCT01746017
Last Updated: 2019-06-03
Results Overview
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Baseline to study completion up to 33 days
Results posted on
2019-06-03
Participant Flow
This is a 2-part dose escalation study: Part A in healthy participants and Part B in participants with type 2 diabetes mellitus (T2DM). Participants in Part A participated in up to 4 intervention periods and participants in Part B participated in up to 3 intervention periods. There was an at least 8 days washout interval between each dosing.
Participant milestones
| Measure |
Part A Cohort 1 Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 10 milligrams (mg) LY2922470; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
|
Part A Cohort 1 Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: 90mg LY2922470; Period 4: Placebo;
|
Part A Cohort 1 Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: Placebo; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
|
Part A Cohort 1 Sequence 4
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 90mg LY2922470; Period 3: Placebo; Period 4: 540mg LY2922470;
|
Part A Cohort 2 Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: Placebo; Period 4: 1350mg LY2922470;
|
Part A Cohort 2 Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: Placebo;
|
Part A Cohort 2 Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: Placebo; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
|
Part A Cohort 2 Sequence 4
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
|
Part B Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 540mg LY2922470; Period 3: 1080mg LY2922470;
|
Part B Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: 540mg LY2922470; Period 3: Placebo;
|
Part B Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: Placebo; Period 3: 1080mg LY2922470;
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
3
|
2
|
3
|
3
|
3
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
2
|
2
|
2
|
2
|
2
|
2
|
3
|
2
|
3
|
3
|
3
|
|
Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
3
|
3
|
3
|
|
Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
1
|
2
|
2
|
3
|
3
|
3
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
2
|
2
|
2
|
2
|
2
|
1
|
2
|
2
|
0
|
0
|
0
|
|
Period 4
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
1
|
2
|
2
|
0
|
0
|
0
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A Cohort 1 Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 10 milligrams (mg) LY2922470; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
|
Part A Cohort 1 Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: 90mg LY2922470; Period 4: Placebo;
|
Part A Cohort 1 Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: Placebo; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
|
Part A Cohort 1 Sequence 4
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 90mg LY2922470; Period 3: Placebo; Period 4: 540mg LY2922470;
|
Part A Cohort 2 Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: Placebo; Period 4: 1350mg LY2922470;
|
Part A Cohort 2 Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: Placebo;
|
Part A Cohort 2 Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: Placebo; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
|
Part A Cohort 2 Sequence 4
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
|
Part B Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 540mg LY2922470; Period 3: 1080mg LY2922470;
|
Part B Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: 540mg LY2922470; Period 3: Placebo;
|
Part B Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: Placebo; Period 3: 1080mg LY2922470;
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2922470 in Healthy Participants and Participants With Diabetes
Baseline characteristics by cohort
| Measure |
Part A Cohort 1 Sequence 1
n=2 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 10 milligrams (mg) LY2922470; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
|
Part A Cohort 1 Sequence 2
n=2 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: 90mg LY2922470; Period 4: Placebo;
|
Part A Cohort 1 Sequence 3
n=2 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: Placebo; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
|
Part A Cohort 1 Sequence 4
n=2 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: Placebo; Period 4: 540mg LY2922470;
|
Part A Cohort 2 Sequence 1
n=2 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: Placebo; Period 4: 1350mg LY2922470;
|
Part A Cohort 2 Sequence 2
n=2 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: Placebo;
|
Part A Cohort 2 Sequence 3
n=3 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: Placebo; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
|
Part A Cohort 2 Sequence 4
n=2 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
|
Part B Sequence 1
n=3 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 540mg LY2922470; Period 3: 1080mg LY2922470;
|
Part B Sequence 2
n=3 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: 540mg LY2922470; Period 3: Placebo;
|
Part B Sequence 3
n=3 Participants
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: Placebo; Period 3: 1080mg LY2922470;
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
26 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
26 Participants
n=21 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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Singapore
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
26 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion up to 33 daysPopulation: All enrolled participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
1350 mg (Part A)
n=6 Participants
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part B)
n=9 Participants
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
|
270 mg (Part B)
n=6 Participants
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
540 mg (Part B)
n=6 Participants
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
1080 mg (Part B)
n=6 Participants
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
10 mg (Part A)
n=6 Participants
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
30 mg (Part A)
n=6 Participants
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
90 mg (Part A)
n=6 Participants
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
270 mg (Part A)
n=6 Participants
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
540 mg (Part A)
n=6 Participants
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part A)
n=15 Participants
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
|
1 mg (Part A)
n=6 Participants
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
3 mg (Part A)
n=6 Participants
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug and had sufficient pharmacokinetics data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.
Outcome measures
| Measure |
1350 mg (Part A)
n=6 Participants
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part B)
n=6 Participants
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
|
270 mg (Part B)
n=5 Participants
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
540 mg (Part B)
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
1080 mg (Part B)
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
10 mg (Part A)
n=6 Participants
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
30 mg (Part A)
n=6 Participants
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
90 mg (Part A)
n=6 Participants
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
270 mg (Part A)
n=6 Participants
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
540 mg (Part A)
n=6 Participants
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part A)
n=6 Participants
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
|
1 mg (Part A)
n=6 Participants
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
3 mg (Part A)
n=6 Participants
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]
|
15200 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
33700 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
78200 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42
|
—
|
—
|
2340 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
6110 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
13300 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
23900 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 50
|
50200 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 46
|
52.1 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
194 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
658 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdosePopulation: All enrolled participants who received at least 1 dose of study drug and had sufficient pharmacokinetics data to calculate Cmax. Participants were analyzed based on the treatment they received.
Outcome measures
| Measure |
1350 mg (Part A)
n=6 Participants
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part B)
n=6 Participants
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
|
270 mg (Part B)
n=5 Participants
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
540 mg (Part B)
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
1080 mg (Part B)
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
10 mg (Part A)
n=6 Participants
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
30 mg (Part A)
n=6 Participants
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
90 mg (Part A)
n=6 Participants
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
270 mg (Part A)
n=6 Participants
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
540 mg (Part A)
n=6 Participants
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part A)
n=6 Participants
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
|
1 mg (Part A)
n=6 Participants
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
3 mg (Part A)
n=6 Participants
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
|
2000 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
3780 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
7950 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
—
|
—
|
457 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
1030 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
2320 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
4130 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
6050 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
11.1 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
30.5 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
111 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
SECONDARY outcome
Timeframe: Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdosePopulation: All participants who received at least 1 dose of study drug with both baseline and 24 hours postdose glucose AUEC(0-24) values. Participants were analyzed based on the treatment they received.
Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Outcome measures
| Measure |
1350 mg (Part A)
n=6 Participants
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part B)
n=9 Participants
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
|
270 mg (Part B)
n=6 Participants
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
540 mg (Part B)
n=6 Participants
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
1080 mg (Part B)
n=6 Participants
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
10 mg (Part A)
n=6 Participants
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
30 mg (Part A)
n=6 Participants
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
90 mg (Part A)
n=6 Participants
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
270 mg (Part A)
n=6 Participants
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
540 mg (Part A)
n=6 Participants
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part A)
n=15 Participants
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
|
1 mg (Part A)
n=6 Participants
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
3 mg (Part A)
n=6 Participants
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)]
|
7.34 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.61
|
-11.47 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.68
|
-19.95 millimoles*hour/Liter (mmol*h/L)
Standard Error 9.08
|
-21.01 millimoles*hour/Liter (mmol*h/L)
Standard Error 9.10
|
-27.19 millimoles*hour/Liter (mmol*h/L)
Standard Error 9.07
|
8.20 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.46
|
2.04 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.43
|
3.68 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.47
|
10.76 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.37
|
-0.34 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.46
|
6.88 millimoles*hour/Liter (mmol*h/L)
Standard Error 1.52
|
10.49 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.64
|
1.29 millimoles*hour/Liter (mmol*h/L)
Standard Error 3.67
|
SECONDARY outcome
Timeframe: Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdosePopulation: All participants who received at least 1 dose of study drug with both baseline and 6 hours postdose C-peptide AUEC(0-6) values. Participants were analyzed based on the treatment they received.
LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Outcome measures
| Measure |
1350 mg (Part A)
n=6 Participants
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part B)
n=9 Participants
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
|
270 mg (Part B)
n=6 Participants
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
540 mg (Part B)
n=6 Participants
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
1080 mg (Part B)
n=6 Participants
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
10 mg (Part A)
n=6 Participants
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
30 mg (Part A)
n=6 Participants
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
90 mg (Part A)
n=6 Participants
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
270 mg (Part A)
n=6 Participants
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
540 mg (Part A)
n=6 Participants
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part A)
n=15 Participants
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
|
1 mg (Part A)
n=6 Participants
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
3 mg (Part A)
n=6 Participants
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)]
|
6442.33 picomoles*hour/Liter (pmol*h/L)
Standard Error 1307.48
|
1518.13 picomoles*hour/Liter (pmol*h/L)
Standard Error 560.25
|
1657.94 picomoles*hour/Liter (pmol*h/L)
Standard Error 1428.92
|
5496.32 picomoles*hour/Liter (pmol*h/L)
Standard Error 1430.24
|
1790.26 picomoles*hour/Liter (pmol*h/L)
Standard Error 1428.57
|
5465.01 picomoles*hour/Liter (pmol*h/L)
Standard Error 1257.11
|
6351.84 picomoles*hour/Liter (pmol*h/L)
Standard Error 1242.12
|
6651.32 picomoles*hour/Liter (pmol*h/L)
Standard Error 1264.87
|
7472.28 picomoles*hour/Liter (pmol*h/L)
Standard Error 1259.71
|
6499.90 picomoles*hour/Liter (pmol*h/L)
Standard Error 1263.96
|
7349.88 picomoles*hour/Liter (pmol*h/L)
Standard Error 871.01
|
6314.08 picomoles*hour/Liter (pmol*h/L)
Standard Error 1257.47
|
6270.86 picomoles*hour/Liter (pmol*h/L)
Standard Error 1262.57
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
1 mg (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
3 mg (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
30 mg (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
90 mg (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
270 mg (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
540 mg (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1350 mg (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo (Part B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
270 mg (Part B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
540 mg (Part B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1080 mg (Part B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (Part A)
n=15 participants at risk
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
|
1 mg (Part A)
n=6 participants at risk
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
3 mg (Part A)
n=6 participants at risk
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
10 mg (Part A)
n=6 participants at risk
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
30 mg (Part A)
n=6 participants at risk
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
90 mg (Part A)
n=6 participants at risk
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
270 mg (Part A)
n=6 participants at risk
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
540 mg (Part A)
n=6 participants at risk
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
1350 mg (Part A)
n=6 participants at risk
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
|
Placebo (Part B)
n=9 participants at risk
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
|
270 mg (Part B)
n=6 participants at risk
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
540 mg (Part B)
n=6 participants at risk
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
1080 mg (Part B)
n=6 participants at risk
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Catheter site erythema
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Catheter site haematoma
|
6.7%
1/15 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Catheter site pain
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Catheter site pruritus
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Catheter site swelling
|
6.7%
1/15 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Chills
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
6.7%
1/15 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/15
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/15
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
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