Trial Outcomes & Findings for A Study of LY2216684 in Major Depressive Disorder in Patients Taking Selective Serotonin Reuptake Inhibitors (NCT NCT01263223)
NCT ID: NCT01263223
Last Updated: 2018-10-23
Results Overview
Heart rate was determined during ambulatory blood pressure monitoring (ABPM). Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 1 (0 to 24 hours). Least Squares (LS) mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
COMPLETED
PHASE1
24 participants
Baseline through the 24-hour interval on Day 1
2018-10-23
Participant Flow
Participant milestones
| Measure |
18-mg LY2216684; Placebo; 36-mg LY2216684 or Placebo
Period 1: 18-milligram (mg) LY2216684 (LY) administered orally once daily on Days 1-4
Period 2: Placebo administered orally, once daily on Days 1-4
Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4
|
Placebo; 18-mg LY2216684; Placebo or 36-mg LY2216684
Period 1: Placebo administered orally, once daily on Days 1-4
Period 2: 18-mg LY2216684 administered orally, once daily on Days 1-4
Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4
|
|---|---|---|
|
Period 1
STARTED
|
12
|
12
|
|
Period 1
COMPLETED
|
12
|
12
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
3-Day Washout
STARTED
|
12
|
12
|
|
3-Day Washout
COMPLETED
|
12
|
12
|
|
3-Day Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
12
|
12
|
|
Period 2
COMPLETED
|
12
|
11
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
|
Period 3
STARTED
|
12
|
11
|
|
Period 3
COMPLETED
|
12
|
11
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
|
7-day Follow-up
STARTED
|
12
|
11
|
|
7-day Follow-up
COMPLETED
|
11
|
10
|
|
7-day Follow-up
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
18-mg LY2216684; Placebo; 36-mg LY2216684 or Placebo
Period 1: 18-milligram (mg) LY2216684 (LY) administered orally once daily on Days 1-4
Period 2: Placebo administered orally, once daily on Days 1-4
Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4
|
Placebo; 18-mg LY2216684; Placebo or 36-mg LY2216684
Period 1: Placebo administered orally, once daily on Days 1-4
Period 2: 18-mg LY2216684 administered orally, once daily on Days 1-4
Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4
|
|---|---|---|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
|
7-day Follow-up
Withdrawal by Subject
|
0
|
1
|
|
7-day Follow-up
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study of LY2216684 in Major Depressive Disorder in Patients Taking Selective Serotonin Reuptake Inhibitors
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=24 Participants
Period 1: 18-mg LY2216684 or Placebo administered orally, once daily on Days 1-4.
Period 2: Participants who received LY2216684 in Period 1, then received Placebo administered orally, once daily on Days 1-4 in Period 2. Participants who received Placebo in Period 1, then received 18-mg LY2216684 administered orally, once daily on Days 1-4 in Period 2.
Period 3: 36-mg LY2216684 or Placebo administered orally, once daily on Days 1-4.
|
|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through the 24-hour interval on Day 1Population: All participants with a baseline observation and at least 1 post-baseline observation on Day 1 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.
Heart rate was determined during ambulatory blood pressure monitoring (ABPM). Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 1 (0 to 24 hours). Least Squares (LS) mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Outcome measures
| Measure |
18-mg LY2216684
n=23 Observations
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
Placebo
n=27 Observations
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|
|
Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1
Mean Change
|
13.3 beats per minute (bpm)
Interval 9.9 to 16.7
|
3.6 beats per minute (bpm)
Interval 0.3 to 6.9
|
|
Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 1
Maximum Change
|
57.5 beats per minute (bpm)
Interval 50.9 to 64.1
|
33.1 beats per minute (bpm)
Interval 27.0 to 39.2
|
PRIMARY outcome
Timeframe: Baseline through the 24-hour interval on Day 4Population: All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 18-mg LY2216684 were made in Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.
Heart rate was determined during ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Maximum and mean changes in ABPM heart rate were determined from 24 hour continuous ABPM monitoring for Day 4 (0 to 24 hours). LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Outcome measures
| Measure |
18-mg LY2216684
n=22 Observations
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
Placebo
n=27 Observations
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|
|
Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 4
Mean Change
|
16.6 beats per minute (bpm)
Interval 13.2 to 20.1
|
3.0 beats per minute (bpm)
Interval -0.3 to 6.3
|
|
Maximum and Mean Change From Baseline in Ambulatory Heart Rate on Day 4
Maximum Change
|
58.7 beats per minute (bpm)
Interval 52.1 to 65.4
|
31.1 beats per minute (bpm)
Interval 25.0 to 37.2
|
SECONDARY outcome
Timeframe: Baseline through the 24-hour interval on Day 1Population: All participants with a baseline observation and at least 1 post-baseline observation on Day 1 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.
Blood pressure (BP) was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 1. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Outcome measures
| Measure |
18-mg LY2216684
n=23 Observations
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
Placebo
n=27 Observations
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|
|
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1
Mean Change, Systolic BP
|
3.0 millimeter of mercury (mm Hg)
Interval -0.2 to 6.1
|
-3.4 millimeter of mercury (mm Hg)
Interval -6.3 to -0.4
|
|
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1
Maximum Change, Systolic BP
|
28.8 millimeter of mercury (mm Hg)
Interval 24.6 to 33.1
|
21.8 millimeter of mercury (mm Hg)
Interval 17.9 to 25.6
|
|
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1
Mean Change, Diastolic BP
|
0.8 millimeter of mercury (mm Hg)
Interval -1.6 to 3.2
|
-4.7 millimeter of mercury (mm Hg)
Interval -7.0 to -2.4
|
|
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 1
Maximum Change, Diastolic BP
|
24.3 millimeter of mercury (mm Hg)
Interval 21.0 to 27.7
|
18.7 millimeter of mercury (mm Hg)
Interval 15.6 to 21.7
|
SECONDARY outcome
Timeframe: Baseline through the 24-hour interval on Day 4Population: All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 18-mg LY2216684 included Periods 1 and 2. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.
BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Outcome measures
| Measure |
18-mg LY2216684
n=22 Observations
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
Placebo
n=27 Observations
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|
|
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4
Mean Change, Diastolic BP
|
0.04 millimeter of mercury (mm Hg)
Interval -2.4 to 2.4
|
-5.1 millimeter of mercury (mm Hg)
Interval -7.4 to -2.8
|
|
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4
Mean Change, Systolic BP
|
-0.3 millimeter of mercury (mm Hg)
Interval -3.4 to 2.8
|
-3.2 millimeter of mercury (mm Hg)
Interval -6.2 to -0.2
|
|
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4
Maximum Change, Systolic BP
|
24.1 millimeter of mercury (mm Hg)
Interval 19.9 to 28.4
|
21.4 millimeter of mercury (mm Hg)
Interval 17.6 to 25.3
|
|
Maximum and Mean Change From Baseline in Ambulatory Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or Placebo on Day 4
Maximum Change, Diastolic BP
|
22.6 millimeter of mercury (mm Hg)
Interval 19.3 to 26.0
|
16.1 millimeter of mercury (mm Hg)
Interval 13.0 to 19.2
|
SECONDARY outcome
Timeframe: Baseline through the 24-hour interval on Day 4Population: All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 36-mg LY2216684 included Period 3. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.
Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Outcome measures
| Measure |
18-mg LY2216684
n=18 Observations
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
Placebo
n=27 Observations
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|
|
Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 36-mg LY2216684 or Placebo on Day 4
Mean Change
|
15.8 beats per minute (bpm)
Interval 11.8 to 19.7
|
3.0 beats per minute (bpm)
Interval -0.3 to 6.3
|
|
Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 36-mg LY2216684 or Placebo on Day 4
Maximum Change
|
54.1 beats per minute (bpm)
Interval 45.4 to 62.7
|
31.1 beats per minute (bpm)
Interval 25.0 to 37.2
|
SECONDARY outcome
Timeframe: Baseline through the 24-hour interval on Day 4Population: All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses. Observations with 36-mg LY2216684 included Period 3. Observations with Placebo included Periods 1, 2, and 3. Therefore, some participants contributed 2 Placebo observations to the overall data.
BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Outcome measures
| Measure |
18-mg LY2216684
n=18 Observations
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
Placebo
n=27 Observations
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|
|
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4
Mean Change, Systolic BP
|
-0.4 millimeter of mercury (mm Hg)
Interval -4.2 to 3.4
|
-3.2 millimeter of mercury (mm Hg)
Interval -6.2 to -0.2
|
|
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4
Maximum Change, Systolic BP
|
29.0 millimeter of mercury (mm Hg)
Interval 23.2 to 34.7
|
21.4 millimeter of mercury (mm Hg)
Interval 17.6 to 25.3
|
|
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4
Mean Change, Diastolic BP
|
-1.5 millimeter of mercury (mm Hg)
Interval -4.3 to 1.4
|
-5.1 millimeter of mercury (mm Hg)
Interval -7.4 to -2.8
|
|
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 36-mg LY2216684 or Placebo on Day 4
Maximum Change, Diastolic BP
|
16.6 millimeter of mercury (mm Hg)
Interval 12.1 to 21.2
|
16.1 millimeter of mercury (mm Hg)
Interval 13.0 to 19.2
|
SECONDARY outcome
Timeframe: Baseline through the 24-hour interval on Day 4Population: All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses.
Heart rate was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM heart rate were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Outcome measures
| Measure |
18-mg LY2216684
n=22 Participants
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
Placebo
n=18 Participants
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|
|
Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Mean Change
|
16.6 beats per minute (bpm)
Interval 13.2 to 20.1
|
15.8 beats per minute (bpm)
Interval 11.8 to 19.7
|
|
Maximum and Mean Change From Baseline in ABPM Heart Rate During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Maximum Change
|
58.7 beats per minute (bpm)
Interval 52.1 to 65.4
|
54.1 beats per minute (bpm)
Interval 45.4 to 62.7
|
SECONDARY outcome
Timeframe: Baseline through the 24-hour interval on Day 4Population: All participants with a baseline observation and at least 1 post-baseline observation on Day 4 were included in the analyses.
BP was determined with ABPM. Mean pre-dose ABPM values from Day 1 in Period 1 were used as baseline. Changes in ABPM BP were determined from a 24-hour continuous ABPM monitoring for Day 4. LS mean changes from baseline were calculated with a mixed effects model including sequence, period, study day, treatment groups, and interaction between treatment groups and study day as fixed effects, and subject as random effect.
Outcome measures
| Measure |
18-mg LY2216684
n=22 Participants
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
Placebo
n=18 Participants
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|
|
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Mean Change, Diastolic BP
|
0.04 millimeter of mercury (mm Hg)
Interval -2.4 to 2.4
|
-1.5 millimeter of mercury (mm Hg)
Interval -4.3 to 1.4
|
|
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Mean Change, Systolic BP
|
-0.3 millimeter of mercury (mm Hg)
Interval -3.4 to 2.8
|
-0.4 millimeter of mercury (mm Hg)
Interval -4.2 to 3.4
|
|
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Maximum Change, Systolic BP
|
24.1 millimeter of mercury (mm Hg)
Interval 19.9 to 28.4
|
29.0 millimeter of mercury (mm Hg)
Interval 23.2 to 34.7
|
|
Maximum and Mean Change From Baseline in ABPM Systolic and Diastolic Blood Pressure During Treatment With 18-mg LY2216684 or 36-mg LY2216684 on Day 4
Maximum Change, Diastolic BP
|
22.6 millimeter of mercury (mm Hg)
Interval 19.3 to 26.0
|
16.6 millimeter of mercury (mm Hg)
Interval 12.1 to 21.2
|
Adverse Events
18-mg LY2216684
36-mg LY2216684
Placebo
Serious adverse events
| Measure |
18-mg LY2216684
n=24 participants at risk
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
36-mg LY2216684
n=19 participants at risk
Participants received a single, oral dose of 36-mg LY2216684 each day over 4 days.
|
Placebo
n=24 participants at risk
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
Other adverse events
| Measure |
18-mg LY2216684
n=24 participants at risk
Participants received a single, oral dose of 18-mg LY2216684 each day over 4 days.
|
36-mg LY2216684
n=19 participants at risk
Participants received a single, oral dose of 36-mg LY2216684 each day over 4 days.
|
Placebo
n=24 participants at risk
Participants received a single, oral dose of Placebo each day over 4 days.
|
|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/19 • Periods 1, 2, and 3 through 7-day follow-up
|
4.2%
1/24 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
4.2%
1/24 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3 • Periods 1, 2, and 3 through 7-day follow-up
|
26.3%
5/19 • Number of events 5 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • Number of events 3 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/19 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
General disorders
Feeling cold
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/19 • Periods 1, 2, and 3 through 7-day follow-up
|
8.3%
2/24 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Investigations
Blood pressure increased
|
4.2%
1/24 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
4.2%
1/24 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Investigations
Heart rate increased
|
37.5%
9/24 • Number of events 9 • Periods 1, 2, and 3 through 7-day follow-up
|
15.8%
3/19 • Number of events 3 • Periods 1, 2, and 3 through 7-day follow-up
|
4.2%
1/24 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
15.8%
3/19 • Number of events 3 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Nervous system disorders
Dizziness
|
16.7%
4/24 • Number of events 5 • Periods 1, 2, and 3 through 7-day follow-up
|
10.5%
2/19 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
4.2%
1/24 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
12.5%
3/24 • Number of events 4 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Nervous system disorders
Paraesthesia
|
12.5%
3/24 • Number of events 3 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Psychiatric disorders
Abnormal dreams
|
8.3%
2/24 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Psychiatric disorders
Insomnia
|
4.2%
1/24 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
10.5%
2/19 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
12.5%
3/24 • Number of events 4 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Renal and urinary disorders
Dysuria
|
8.3%
2/24 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Renal and urinary disorders
Urinary hesitation
|
8.3%
2/24 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
10.5%
2/19 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Reproductive system and breast disorders
Menstrual disorder
|
6.7%
1/15 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/12 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/15 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/15 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/12 • Periods 1, 2, and 3 through 7-day follow-up
|
6.7%
1/15 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/19 • Periods 1, 2, and 3 through 7-day follow-up
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/24 • Periods 1, 2, and 3 through 7-day follow-up
|
10.5%
2/19 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
4.2%
1/24 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
|
Vascular disorders
Hot flush
|
12.5%
3/24 • Number of events 3 • Periods 1, 2, and 3 through 7-day follow-up
|
5.3%
1/19 • Number of events 1 • Periods 1, 2, and 3 through 7-day follow-up
|
8.3%
2/24 • Number of events 2 • Periods 1, 2, and 3 through 7-day follow-up
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60