Trial Outcomes & Findings for A Study of LY2623091 in Male and Females With Chronic Kidney Disease (NCT NCT01427972)

NCT ID: NCT01427972

Last Updated: 2019-09-09

Results Overview

Proteinuria was the presence of excess serum protein in the urine. Proteinuria was calculated for each participant after each treatment period. Change was calculated as (Day 21 post-treatment value) minus (baseline value).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: Over 24 hours at Baseline and on Day 21
• Results posted on: 2019-09-09

Participant Flow

Participants (pts) were randomized to 1 of 4 arms, 3 LY2623091 (LY) and Eplerenone (Epl). Each participated in two 21-day treatment periods with washout period of at least 28 days. Pts who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Pts who received Epl in Period 1 were randomized to an LY arm in Period 2.

Participant milestones

Measure	1.5 mg LY2623091 First Then 10 mg LY2623091 Participants received 1.5 milligram (mg) LY2623091 administered orally, once daily (QD) for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	1.5 mg LY2623091 First Then 50 mg Eplerenone Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	1.5 mg LY2623091 First Then 0.2 mg LY2623091 Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 0.2 mg LY2623091 Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 1.5 mg LY2623091 Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 10 mg LY2623091 Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 10 mg LY2623091 Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 50 mg Eplerenone Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 1.5 mg LY2623091 Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10mg LY2623091 First Then 50mg Eplerenone Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10mg LY2623091 First Then 0.2 mg LY2623091 Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10 mg LY2623091 First Then 1.5 mg LY2623091 Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
Treatment Period 1 (21 Days) STARTED	3	4	4	3	4	3	3	5	3	3	3	4
Treatment Period 1 (21 Days) Received at Least 1 Dose of Study Drug	3	4	4	3	4	3	3	5	3	3	3	4
Treatment Period 1 (21 Days) COMPLETED	3	4	4	3	4	3	3	4	3	3	3	4
Treatment Period 1 (21 Days) NOT COMPLETED	0	0	0	0	0	0	0	1	0	0	0	0
Washout (at Least 28 Days) STARTED	3	4	4	3	4	3	3	4	3	3	3	4
Washout (at Least 28 Days) COMPLETED	3	4	4	3	4	1	3	4	3	3	3	4
Washout (at Least 28 Days) NOT COMPLETED	0	0	0	0	0	2	0	0	0	0	0	0
Treatment Period 2 (21 Days) STARTED	3	4	4	3	4	1	3	4	3	3	3	4
Treatment Period 2 (21 Days) COMPLETED	3	3	4	3	4	1	3	4	3	3	3	4
Treatment Period 2 (21 Days) NOT COMPLETED	0	1	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	1.5 mg LY2623091 First Then 10 mg LY2623091 Participants received 1.5 milligram (mg) LY2623091 administered orally, once daily (QD) for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	1.5 mg LY2623091 First Then 50 mg Eplerenone Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	1.5 mg LY2623091 First Then 0.2 mg LY2623091 Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 0.2 mg LY2623091 Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 1.5 mg LY2623091 Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 10 mg LY2623091 Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 10 mg LY2623091 Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 50 mg Eplerenone Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 1.5 mg LY2623091 Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10mg LY2623091 First Then 50mg Eplerenone Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10mg LY2623091 First Then 0.2 mg LY2623091 Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10 mg LY2623091 First Then 1.5 mg LY2623091 Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.
Treatment Period 1 (21 Days) Protocol Violation	0	0	0	0	0	0	0	1	0	0	0	0
Washout (at Least 28 Days) Withdrawal by Subject	0	0	0	0	0	2	0	0	0	0	0	0
Treatment Period 2 (21 Days) Withdrawal by Subject	0	1	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

A Study of LY2623091 in Male and Females With Chronic Kidney Disease

Baseline characteristics by cohort

Measure	1.5 mg LY2623091 First Then 10 mg LY2623091 n=3 Participants Participants received 1.5 milligram (mg) LY2623091 administered orally, once daily (QD) for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	1.5 mg LY2623091 First Then 50 mg Eplerenone n=4 Participants Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	1.5 mg LY2623091 First Then 0.2 mg LY2623091 n=4 Participants Participants received 1.5 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 0.2 mg LY2623091 n=3 Participants Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 1.5 mg LY2623091 n=4 Participants Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	50mg Eplerenone First Then 10 mg LY2623091 n=3 Participants Participants received 50 mg Eplerenone administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 10 mg LY2623091 n=3 Participants Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 10 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 50 mg Eplerenone n=5 Participants Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	0.2 mg LY2623091 First Then 1.5 mg LY2623091 n=3 Participants Participants received 0.2 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10mg LY2623091 First Then 50mg Eplerenone n=3 Participants Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 50 mg Eplerenone for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10mg LY2623091 First Then 0.2 mg LY2623091 n=3 Participants Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 0.2 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	10 mg LY2623091 First Then 1.5 mg LY2623091 n=4 Participants Participants received 10 mg LY2623091 administered orally, QD for 21 days in treatment period 1 followed by a minimum 28-day washout period before receiving 1.5 mg LY2623091 for 21 days in treatment period 2. On Day 1 through Day 20, participants were in a fed state and on Day 21 participants were in a fasted state.	Total n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	37 Participants n=36 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	5 Participants n=36 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	17 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	25 Participants n=36 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	34 Participants n=36 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=36 Participants
Race/Ethnicity, Customized Mixed	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=36 Participants
Region of Enrollment Bulgaria	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	1 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	20 Participants n=36 Participants
Region of Enrollment South Africa	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	21 Participants n=36 Participants
Region of Enrollment Macedonia	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants

PRIMARY outcome

Timeframe: Over 24 hours at Baseline and on Day 21

Population: All participants who received any study drug and had proteinuria values. Participants were analyzed based on the treatment they received.

Proteinuria was the presence of excess serum protein in the urine. Proteinuria was calculated for each participant after each treatment period. Change was calculated as (Day 21 post-treatment value) minus (baseline value).

Outcome measures

Measure	0.2 mg LY2623091 n=20 Participants 0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	1.5 mg LY2623091 n=22 Participants 1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	10 mg LY2623091 n=17 Participants 10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	50 mg Eplerenone n=21 Participants 50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
Change From Baseline to Day 21 in Proteinuria Based on 24-hours Pooled Urine	-98.9 milligrams/24 hours (mg/24 h) Standard Deviation 1450.56	-19.7 milligrams/24 hours (mg/24 h) Standard Deviation 876.85	119.4 milligrams/24 hours (mg/24 h) Standard Deviation 1923.11	273.7 milligrams/24 hours (mg/24 h) Standard Deviation 1280.34

SECONDARY outcome

Timeframe: Over 0-6 hours at Baseline and on Day 21

Population: All participants who received any study drug and had potassium clearance values. Participants were analyzed based on the treatment they received.

Urine potassium clearance is defined as the amount of renal potassium excreted per volume of urine from participant's pooled urine. The oral potassium challenge consisted of 35 milliequivalents (mEq) potassium administered over 10 minutes as a flavored potassium chloride solution. Change was calculated as (Day 21 values) minus (baseline values).

Outcome measures

Measure	0.2 mg LY2623091 n=10 Participants 0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	1.5 mg LY2623091 n=10 Participants 1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	10 mg LY2623091 n=8 Participants 10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	50 mg Eplerenone n=8 Participants 50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
Change From Baseline to Day 21 in Potassium Clearance Following an Oral Potassium Challenge	0.097 Hour*millimoles per liter (h*mmol/L) Standard Deviation 0.263	-0.122 Hour*millimoles per liter (h*mmol/L) Standard Deviation 0.393	-0.174 Hour*millimoles per liter (h*mmol/L) Standard Deviation 0.243	-0.019 Hour*millimoles per liter (h*mmol/L) Standard Deviation 0.245

SECONDARY outcome

Timeframe: Predose, 1, 2, 4, 8, 12, and 24 hours postdose on Day 20 of Treatment Periods 1 and 2

Population: All participants who received LY2623091 and had AUC0-τ values. Participants were analyzed based on the treatment they received.

Outcome measures

Measure	0.2 mg LY2623091 n=20 Participants 0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	1.5 mg LY2623091 n=22 Participants 1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	10 mg LY2623091 n=17 Participants 10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	50 mg Eplerenone 50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve During the Dosing Period of LY2623091 (AUC0-τ)	75.321 hours*nanogram/milliliter (h*ng/mL) Standard Deviation 31.927	526.640 hours*nanogram/milliliter (h*ng/mL) Standard Deviation 177.834	3096.658 hours*nanogram/milliliter (h*ng/mL) Standard Deviation 1448.414	—

SECONDARY outcome

Timeframe: Predose, 1, 2, 4, 8, 12, and 24 hours postdose on Day 20 of Treatment Periods 1 and 2

Population: All participants who received LY2623091and had Cmax values. Participants were analyzed based on the treatment they received.

Outcome measures

Measure	0.2 mg LY2623091 n=20 Participants 0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	1.5 mg LY2623091 n=22 Participants 1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	10 mg LY2623091 n=17 Participants 10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	50 mg Eplerenone 50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
PK: Maximum Plasma Concentration (Cmax) of LY2623091	4.540 nanograms/milliliter (ng/mL) Standard Deviation 2.003	31.722 nanograms/milliliter (ng/mL) Standard Deviation 10.325	187.441 nanograms/milliliter (ng/mL) Standard Deviation 87.858	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to end of Treatment Period 2 plus 10-day follow-up (80 days)

Population: All participants who received at least 1 dose of study drug.

Outcome measures

Measure	0.2 mg LY2623091 n=21 Participants 0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	1.5 mg LY2623091 n=22 Participants 1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	10 mg LY2623091 n=17 Participants 10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.	50 mg Eplerenone n=21 Participants 50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days. On Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. There was a minimum 28-day Washout Period between Period 1 and Period 2.
The Number of Participants Who Died While on Study	0 Participants	1 Participants	0 Participants	0 Participants

Adverse Events

10 mg LY2623091

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

50 mg Eplerenone

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

0.2 mg LY2623091

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

1.5 mg LY2623091

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	10 mg LY2623091 n=17 participants at risk 10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.	50 mg Eplerenone n=21 participants at risk 50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.	0.2 mg LY2623091 n=21 participants at risk 0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.	1.5 mg LY2623091 n=22 participants at risk 1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Nervous system disorders Cerebrovascular accident	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Vascular disorders Arterial insufficiency	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.

Other adverse events

Measure	10 mg LY2623091 n=17 participants at risk 10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.	50 mg Eplerenone n=21 participants at risk 50 mg Eplerenone capsules were administered to participants in either Period 1 or Period 2. In each period 50 mg Eplerenone was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.	0.2 mg LY2623091 n=21 participants at risk 0.2 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 0.2 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.	1.5 mg LY2623091 n=22 participants at risk 1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.
General disorders Fatigue	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
General disorders Pyrexia	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 2 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Eye disorders Conjunctivitis	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Eye disorders Eye pain	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Eye disorders Uveitis	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Abdominal discomfort	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Abdominal pain	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Constipation	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	9.1% 2/22 • Number of events 2 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Dyspepsia	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 2 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Lip blister	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	9.5% 2/21 • Number of events 2 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Infections and infestations Dacryocystitis	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Infections and infestations Influenza	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Infections and infestations Kidney infection	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Infections and infestations Nasopharyngitis	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Infections and infestations Rhinitis	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Infections and infestations Urinary tract infection	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Injury, poisoning and procedural complications Overdose	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Investigations Blood creatine phosphokinase increased	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Investigations Blood potassium increased	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Investigations Haemoglobin decreased	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Metabolism and nutrition disorders Hypoglycaemia	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	9.5% 2/21 • Number of events 3 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Nervous system disorders Dizziness	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Nervous system disorders Headache	5.9% 1/17 • Number of events 2 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Nervous system disorders Paraesthesia	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Psychiatric disorders Insomnia	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.5% 1/22 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Vascular disorders Arterial insufficiency	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Vascular disorders Haematoma	5.9% 1/17 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Vascular disorders Hypotension	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.
Vascular disorders Orthostatic hypotension	0.00% 0/17 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	4.8% 1/21 • Number of events 1 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/21 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.	0.00% 0/22 Participants were randomized to 1 of 4 treatment arms, 3 LY2623091 (LY) and 1 Eplerenone (Epl). Each participated in 2 treatment periods and a washout period. Participants who received LY in Period 1 were randomized to a different LY arm or Epl arm in Period 2. Participants who received Epl in Period 1 were randomized to an LY arm in Period 2.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60