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Trial Outcomes & Findings for A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia (NCT NCT02714569)

NCT ID: NCT02714569

Last Updated: 2021-05-25

Results Overview

Number of participants with one or more SAEs in Part A and Part B. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

60 participants

Primary outcome timeframe

Baseline, Up to 42 Days

Results posted on

2021-05-25

Participant Flow

Part A participants were divided into 2 cohorts. Within each cohort, participants were randomized to a treatment sequence (4 periods; up to 3 LY dose levels and at least one placebo). A 2-week washout occurred between each period. Part B participants were divided into 4 cohorts. Within each cohort, participants were randomized to LY or placebo.

Participant milestones

Participant milestones
Measure
Part A: Cohort 1(C1), Sequence 1
1 milligram (mg) of LY3202328 (LY) was taken orally first intervention, then 10 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention. C1, Sequence 1: (1 mg LY, 10 mg LY, Placebo, 600 mg LY)
Part A: C1, Sequence 2
1 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 100 mg of LY was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention. C1, Sequence 2: (1 mg LY, Placebo, 100 mg LY, 600 mg LY)
Part A: C1, Sequence 3
Placebo was taken orally first intervention, then 10 mg LY was taken orally second intervention, then, 100 mg LY was taken orally third intervention, then placebo was taken orally fourth intervention. C1, Sequence 3: (Placebo, 10 mg LY, 100 mg LY, Placebo)
Part A: Cohort 2 (C2), Sequence 1
3 mg of LY was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention. C2, Sequence 1: (3 mg LY, 30 mg LY, Placebo, 30 mg LY Fed)
Part A: C2, Sequence 2
3 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then placebo was taken orally fourth intervention. C2, Sequence 2: (3 mg LY, Placebo, 300 mg LY, Placebo)
Part A: C2, Sequence 3
Placebo was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention. C2, Sequence 3: (Placebo, 30 mg LY, 300 mg LY, 30 mg LY Fed)
Part B: C3 (Simvastatin [SS]/Atorvastatin[AS] + 5 mg LY)
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: C4 (SS/AS + 20 mg LY)
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: C5 (SS/AS + 100 mg LY)
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: C6 (SS/AS + 300 mg LY)
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: C3-C6 (SS/AS + Placebo)
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part A First Intervention
STARTED
3
3
3
3
3
3
0
0
0
0
0
Part A First Intervention
Received at Least One Dose of Study Drug
3
3
3
3
3
3
0
0
0
0
0
Part A First Intervention
COMPLETED
3
3
3
3
3
3
0
0
0
0
0
Part A First Intervention
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
0
Part A Second Intervention
STARTED
3
3
3
3
3
3
0
0
0
0
0
Part A Second Intervention
Received at Least One Dose of Study Drug
3
2
3
3
3
3
0
0
0
0
0
Part A Second Intervention
COMPLETED
3
2
3
3
3
3
0
0
0
0
0
Part A Second Intervention
NOT COMPLETED
0
1
0
0
0
0
0
0
0
0
0
Part A Third Intervention
STARTED
3
2
3
3
3
3
0
0
0
0
0
Part A Third Intervention
Received at Least One Dose of Study Drug
3
2
2
2
3
3
0
0
0
0
0
Part A Third Intervention
COMPLETED
3
2
2
2
3
3
0
0
0
0
0
Part A Third Intervention
NOT COMPLETED
0
0
1
1
0
0
0
0
0
0
0
Part A Fourth Intervention
STARTED
4
2
3
2
3
3
0
0
0
0
0
Part A Fourth Intervention
Received at Least One Dose of Study Drug
3
2
3
2
3
2
0
0
0
0
0
Part A Fourth Intervention
COMPLETED
3
2
3
2
3
2
0
0
0
0
0
Part A Fourth Intervention
NOT COMPLETED
1
0
0
0
0
1
0
0
0
0
0
Part B (Overall)
STARTED
0
0
0
0
0
0
8
8
8
8
8
Part B (Overall)
COMPLETED
0
0
0
0
0
0
7
7
8
6
8
Part B (Overall)
NOT COMPLETED
0
0
0
0
0
0
1
1
0
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Part A: Cohort 1(C1), Sequence 1
1 milligram (mg) of LY3202328 (LY) was taken orally first intervention, then 10 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention. C1, Sequence 1: (1 mg LY, 10 mg LY, Placebo, 600 mg LY)
Part A: C1, Sequence 2
1 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 100 mg of LY was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention. C1, Sequence 2: (1 mg LY, Placebo, 100 mg LY, 600 mg LY)
Part A: C1, Sequence 3
Placebo was taken orally first intervention, then 10 mg LY was taken orally second intervention, then, 100 mg LY was taken orally third intervention, then placebo was taken orally fourth intervention. C1, Sequence 3: (Placebo, 10 mg LY, 100 mg LY, Placebo)
Part A: Cohort 2 (C2), Sequence 1
3 mg of LY was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention. C2, Sequence 1: (3 mg LY, 30 mg LY, Placebo, 30 mg LY Fed)
Part A: C2, Sequence 2
3 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then placebo was taken orally fourth intervention. C2, Sequence 2: (3 mg LY, Placebo, 300 mg LY, Placebo)
Part A: C2, Sequence 3
Placebo was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention. C2, Sequence 3: (Placebo, 30 mg LY, 300 mg LY, 30 mg LY Fed)
Part B: C3 (Simvastatin [SS]/Atorvastatin[AS] + 5 mg LY)
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: C4 (SS/AS + 20 mg LY)
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: C5 (SS/AS + 100 mg LY)
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: C6 (SS/AS + 300 mg LY)
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: C3-C6 (SS/AS + Placebo)
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part A Second Intervention
Withdrawal by Subject
0
1
0
0
0
0
0
0
0
0
0
Part A Third Intervention
Positive Urine Drug Screen (UDS)
0
0
0
1
0
0
0
0
0
0
0
Part A Third Intervention
Adverse Event
0
0
1
0
0
0
0
0
0
0
0
Part A Fourth Intervention
Positive Urinary Drug Screen (UDS)
1
0
0
0
0
1
0
0
0
0
0
Part B (Overall)
Lost to Follow-up
0
0
0
0
0
0
1
0
0
0
0
Part B (Overall)
Withdrawal by Subject
0
0
0
0
0
0
0
1
0
1
0
Part B (Overall)
Adverse Event
0
0
0
0
0
0
0
0
0
1
0

Baseline Characteristics

A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part A, C1, Sequence 1
n=4 Participants
1 mg of LY3202328 (LY) was taken orally first intervention, then 10 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention. C1, Sequence 1: (1 mg LY, 10 mg LY, Placebo, 600 mg LY)
Part A, C1, Sequence 2
n=3 Participants
1 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 100 mg of LY was taken orally third intervention, then 600 mg of LY was taken orally fourth intervention. C1, Sequence 2: (1 mg LY, Placebo, 100 mg LY, 600 mg LY)
Part A, C1, Sequence 3
n=4 Participants
Placebo was taken orally first intervention, then 10 mg LY was taken orally second intervention, then, 100 mg LY was taken orally third intervention, then placebo was taken orally fourth intervention. C1, Sequence 3: (Placebo, 10 mg LY, 100 mg LY, Placebo)
Part A, C2, Sequence 1
n=3 Participants
3 mg of LY was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then placebo was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention C2, Sequence 1: 3 mg LY, 30 mg LY, Placebo, 30 mg LY Fed
Part A, C2, Sequence 2
n=3 Participants
3 mg of LY was taken orally first intervention, then placebo was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then placebo was taken orally fourth intervention. C2, Sequence 2: 3 mg LY, Placebo, 300 mg LY, Placebo
Part A, C2, Sequence 3
n=3 Participants
Placebo was taken orally first intervention, then 30 mg of LY was taken orally second intervention, then 300 mg of LY was taken orally third intervention, then 30 mg of LY fed was taken orally fourth intervention. C2, Sequence 3: Placebo, 30 mg LY, 300 mg LY, 30 mg LY Fed
Part B: SS/AS/Placebo
n=8 Participants
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg LY
n=8 Participants
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg LY
n=8 Participants
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg LY
n=8 Participants
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg LY
n=8 Participants
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Total
n=60 Participants
Total of all reporting groups
Age, Continuous
48.3 years
STANDARD_DEVIATION 8.02 • n=5 Participants
56.0 years
STANDARD_DEVIATION 12.12 • n=7 Participants
58.5 years
STANDARD_DEVIATION 4.04 • n=5 Participants
34.0 years
STANDARD_DEVIATION 13.53 • n=4 Participants
38.3 years
STANDARD_DEVIATION 22.50 • n=21 Participants
54.7 years
STANDARD_DEVIATION 17.21 • n=8 Participants
54.0 years
STANDARD_DEVIATION 9.12 • n=8 Participants
50.5 years
STANDARD_DEVIATION 12.76 • n=24 Participants
46.8 years
STANDARD_DEVIATION 13.13 • n=42 Participants
55.0 years
STANDARD_DEVIATION 10.18 • n=42 Participants
36.9 years
STANDARD_DEVIATION 10.80 • n=42 Participants
48.7 years
STANDARD_DEVIATION 13.22 • n=42 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
4 Participants
n=8 Participants
4 Participants
n=24 Participants
3 Participants
n=42 Participants
4 Participants
n=42 Participants
1 Participants
n=42 Participants
21 Participants
n=42 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
2 Participants
n=8 Participants
4 Participants
n=8 Participants
4 Participants
n=24 Participants
5 Participants
n=42 Participants
4 Participants
n=42 Participants
7 Participants
n=42 Participants
39 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
5 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
7 Participants
n=42 Participants
2 Participants
n=42 Participants
15 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
3 Participants
n=8 Participants
3 Participants
n=8 Participants
8 Participants
n=24 Participants
8 Participants
n=42 Participants
1 Participants
n=42 Participants
6 Participants
n=42 Participants
45 Participants
n=42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=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
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=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
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=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
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=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
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
2 Participants
n=21 Participants
1 Participants
n=8 Participants
1 Participants
n=8 Participants
2 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
13 Participants
n=42 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
2 Participants
n=8 Participants
7 Participants
n=8 Participants
6 Participants
n=24 Participants
8 Participants
n=42 Participants
8 Participants
n=42 Participants
8 Participants
n=42 Participants
47 Participants
n=42 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=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
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=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
Region of Enrollment
United States
4 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=21 Participants
3 Participants
n=8 Participants
8 Participants
n=8 Participants
8 Participants
n=24 Participants
8 Participants
n=42 Participants
8 Participants
n=42 Participants
8 Participants
n=42 Participants
60 Participants
n=42 Participants

PRIMARY outcome

Timeframe: Baseline, Up to 42 Days

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

Number of participants with one or more SAEs in Part A and Part B. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=20 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=7 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=6 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=8 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=6 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
n=7 Participants
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
n=6 Participants
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
n=7 Participants
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
n=7 Participants
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
n=8 Participants
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
n=8 Participants
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
n=8 Participants
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
n=8 Participants
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
n=8 Participants
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants
1 participants

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A after a single dose.

Pharmacokinetics (PK) is the maximum plasma concentration (Cmax) of LY3202328 Part A after a single dose.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=6 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=6 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=6 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=6 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=4 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
n=6 Participants
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
n=5 Participants
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
n=4 Participants
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose
48.258 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 21.11
105.023 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 26.66
340.829 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 28.99
581.782 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 32.29
1600.953 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 40.01
1632.595 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 42.84
2866.855 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 51.29
1105.999 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 18.47
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SECONDARY outcome

Timeframe: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

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

PK is the maximum plasma concentration of LY3202328 (Cmax) at steady state in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=7 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=8 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=8 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B
445.858 ng/ml
Geometric Coefficient of Variation 32.78
882.125 ng/ml
Geometric Coefficient of Variation 32.81
3687.167 ng/ml
Geometric Coefficient of Variation 34.83
3209.396 ng/ml
Geometric Coefficient of Variation 37.31
—
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A after a single dose.

PK is the area under the serum concentration time curve from zero to Infinity (AUC\[0-∞\]) of LY3202328 in Part A after a single dose.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=1 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=3 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=6 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=6 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=4 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
n=6 Participants
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
n=2 Participants
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
n=4 Participants
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean/Coefficient Variation (CV) was not calculated due to n=1. Minimum and maximum values = 1607.0, 1607.0.
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean/CV was not calculated due to small sample size n=3. Minimum and maximum values = 2632.0, 3047.0
7726.17 ng/mL
Geometric Coefficient of Variation 45.23
17018.43 ng/mL
Geometric Coefficient of Variation 62.60
55406.24 ng/mL
Geometric Coefficient of Variation 41.35
66185.70 ng/mL
Geometric Coefficient of Variation 71.44
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean/CV was not calculated due to n=2. Minimum and maximum values = 63062.0, 83978.0.
28415.22 ng/mL
Geometric Coefficient of Variation 56.67
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

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

PK is the area under the serum concentration-time curve (AUCτ) of LY3202328 at steady state during the dosing interval in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=7 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=8 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=8 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B
7587.24 hour*nanogram/milliliter(hr*ng/ml)
Geometric Coefficient of Variation 38.612
13362.44 hour*nanogram/milliliter(hr*ng/ml)
Geometric Coefficient of Variation 44.984
67499.80 hour*nanogram/milliliter(hr*ng/ml)
Geometric Coefficient of Variation 37.465
50774.85 hour*nanogram/milliliter(hr*ng/ml)
Geometric Coefficient of Variation 43.861
—
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose

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

PK is the time to maximum concentration (Tmax) of LY3202328 in Part A

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=6 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=6 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=6 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=6 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=4 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
n=6 Participants
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
n=5 Participants
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
n=4 Participants
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A
2.02 hour (hr)
Interval 1.0 to 4.0
3.52 hour (hr)
Interval 2.0 to 6.2
4.0 hour (hr)
Interval 2.0 to 6.0
4.00 hour (hr)
Interval 3.0 to 4.1
6.00 hour (hr)
Interval 2.0 to 8.0
4.02 hour (hr)
Interval 3.0 to 8.0
4.00 hour (hr)
Interval 2.0 to 24.0
5.00 hour (hr)
Interval 4.0 to 8.0
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

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

PK is the Tmax of LY3202328 at steady state in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=7 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=8 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=8 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: Steady State Tmax of LY3202328 (LY) in Part B
2.00 hr
Interval 2.0 to 6.0
4.20 hr
Interval 4.0 to 6.0
3.00 hr
Interval 2.0 to 4.0
3.04 hr
Interval 1.0 to 6.0
—
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Predose, 24, 48, 96 Hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable fasting HDL-c data in Part A.

Pharmacodynamics (PD) is the change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=19 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=6 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=6 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=5 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=6 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
n=6 Participants
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
n=5 Participants
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
n=5 Participants
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A
24 Hours
-0.003 millimole/Liter (mmol/L)
Standard Deviation 0.1155
-0.030 millimole/Liter (mmol/L)
Standard Deviation 0.0842
-0.043 millimole/Liter (mmol/L)
Standard Deviation 0.0454
-0.047 millimole/Liter (mmol/L)
Standard Deviation 0.0740
-0.026 millimole/Liter (mmol/L)
Standard Deviation 0.0433
0.052 millimole/Liter (mmol/L)
Standard Deviation 0.1099
-0.004 millimole/Liter (mmol/L)
Standard Deviation 0.0684
0.010 millimole/Liter (mmol/L)
Standard Deviation 0.0232
—
—
—
—
—
—
Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A
48 Hours
-0.037 millimole/Liter (mmol/L)
Standard Deviation 0.1560
-0.039 millimole/Liter (mmol/L)
Standard Deviation 0.0217
0.009 millimole/Liter (mmol/L)
Standard Deviation 0.1387
-0.043 millimole/Liter (mmol/L)
Standard Deviation 0.0950
-0.026 millimole/Liter (mmol/L)
Standard Deviation 0.1010
0.019 millimole/Liter (mmol/L)
Standard Deviation 0.0978
-0.009 millimole/Liter (mmol/L)
Standard Deviation 0.1551
-0.052 millimole/Liter (mmol/L)
Standard Deviation 0.0755
—
—
—
—
—
—
Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A
96 Hours
-0.074 millimole/Liter (mmol/L)
Standard Deviation 0.1258
-0.073 millimole/Liter (mmol/L)
Standard Deviation 0.1241
-0.086 millimole/Liter (mmol/L)
Standard Deviation 0.0892
-0.134 millimole/Liter (mmol/L)
Standard Deviation 0.0553
-0.030 millimole/Liter (mmol/L)
Standard Deviation 0.1304
-0.091 millimole/Liter (mmol/L)
Standard Deviation 0.1206
-0.082 millimole/Liter (mmol/L)
Standard Deviation 0.1487
-0.005 millimole/Liter (mmol/L)
Standard Deviation 0.1411
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Predose, Days 7, 14, 21, and 28 Postdose

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

PD is the change from baseline to last day of dosing in fasting HDL-c in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=8 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=7 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=8 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=8 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=8 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B
0.008 mmol/L
Standard Deviation 0.1169
-0.010 mmol/L
Standard Deviation 0.1165
-0.101 mmol/L
Standard Deviation 0.0812
-0.107 mmol/L
Standard Deviation 0.1894
-0.101 mmol/L
Standard Deviation 0.0621
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Predose, 24, 48, 96 Hours Postdose

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

PD is the change from baseline in fasting total triglycerides in Part A.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=19 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=6 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=6 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=5 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=6 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
n=6 Participants
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
n=5 Participants
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
n=5 Participants
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PD: Change From Baseline in Fasting Total Triglycerides Part A
24 Hours
-0.276 mmol/L
Standard Deviation 0.2043
-0.397 mmol/L
Standard Deviation 0.2877
-0.190 mmol/L
Standard Deviation 0.1491
-0.386 mmol/L
Standard Deviation 0.2766
-0.311 mmol/L
Standard Deviation 0.2831
-0.523 mmol/L
Standard Deviation 0.5801
-0.064 mmol/L
Standard Deviation 0.1455
-0.302 mmol/L
Standard Deviation 0.2318
—
—
—
—
—
—
PD: Change From Baseline in Fasting Total Triglycerides Part A
48 Hours
-0.320 mmol/L
Standard Deviation 0.3162
-0.269 mmol/L
Standard Deviation 0.2260
-0.115 mmol/L
Standard Deviation 0.2643
-0.260 mmol/L
Standard Deviation 0.3382
-0.418 mmol/L
Standard Deviation 0.3290
-0.766 mmol/L
Standard Deviation 0.5870
-0.226 mmol/L
Standard Deviation 0.3646
-0.198 mmol/L
Standard Deviation 0.1345
—
—
—
—
—
—
PD: Change From Baseline in Fasting Total Triglycerides Part A
96 Hours
-0.239 mmol/L
Standard Deviation 0.3227
-0.209 mmol/L
Standard Deviation 0.6817
-0.132 mmol/L
Standard Deviation 0.2349
0.013 mmol/L
Standard Deviation 0.7179
-0.331 mmol/L
Standard Deviation 0.4343
-0.455 mmol/L
Standard Deviation 0.5144
-0.326 mmol/L
Standard Deviation 0.3549
0.158 mmol/L
Standard Deviation 0.6773
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Predose, Days 7, 14, 21, and 28 Postdose

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

PD is the change from baseline to last day of dosing in fasting total triglycerides in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=8 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=8 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=8 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=8 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B
0.205 mmol/L
Standard Deviation 0.6757
-0.131 mmol/L
Standard Deviation 0.2720
-0.231 mmol/L
Standard Deviation 0.5383
0.020 mmol/L
Standard Deviation 0.6281
-0.480 mmol/L
Standard Deviation 0.5235
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Predose, 24, 28, 96 Hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable fasting total cholesterol data in Part A.

PD is the change from baseline in fasting total cholesterol in Part A.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=19 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=6 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=6 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=5 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=6 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
n=4 Participants
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
n=6 Participants
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
n=5 Participants
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PD: Change From Baseline to in Fasting Total Cholesterol in Part A
24 Hours
0.085 mmol/L
Standard Deviation 0.3075
-0.186 mmol/L
Standard Deviation 0.2699
-0.013 mmol/L
Standard Deviation 0.2850
-0.203 mmol/L
Standard Deviation 0.2157
0.073 mmol/L
Standard Deviation 0.1863
0.285 mmol/L
Standard Deviation 0.1903
0.203 mmol/L
Standard Deviation 0.2421
0.093 mmol/L
Standard Deviation 0.1560
—
—
—
—
—
—
PD: Change From Baseline to in Fasting Total Cholesterol in Part A
48 Hours
-0.085 mmol/L
Standard Deviation 0.4618
-0.436 mmol/L
Standard Deviation 0.2608
-0.030 mmol/L
Standard Deviation 0.2218
-0.376 mmol/L
Standard Deviation 0.2321
-0.013 mmol/L
Standard Deviation 0.3981
0.091 mmol/L
Standard Deviation 0.3654
0.134 mmol/L
Standard Deviation 0.5446
-0.026 mmol/L
Standard Deviation 0.4719
—
—
—
—
—
—
PD: Change From Baseline to in Fasting Total Cholesterol in Part A
96 Hours
-0.318 mmol/L
Standard Deviation 0.4288
-0.527 mmol/L
Standard Deviation 0.3262
-0.207 mmol/L
Standard Deviation 0.2949
-0.609 mmol/L
Standard Deviation 0.2635
-0.199 mmol/L
Standard Deviation 0.4732
-0.317 mmol/L
Standard Deviation 0.6296
-0.155 mmol/L
Standard Deviation 0.4826
-0.041 mmol/L
Standard Deviation 0.6020
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Predose, Days 7, 14, 21, and 28 Postdose

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

PD is the change from baseline to last day of dosing in fasting total cholesterol in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=8 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=8 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=8 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=8 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B
0.206 mmol/L
Standard Deviation 0.3615
0.118 mmol/L
Standard Deviation 0.3840
0.183 mmol/L
Standard Deviation 0.4681
0.174 mmol/L
Standard Deviation 0.4963
-0.190 mmol/L
Standard Deviation 0.4425
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Predose, 24, 48, 96 Hours Postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable LDL-c data in Part A.

PD is the change from baseline in fasting low-density lipoprotein cholesterol (LDL-c) Part A.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=19 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=6 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=6 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=5 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=6 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
n=6 Participants
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
n=5 Participants
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
n=5 Participants
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A
24 Hours
0.231 mmol/L
Standard Deviation 0.2513
0.025 mmol/L
Standard Deviation 0.2205
0.117 mmol/L
Standard Deviation 0.2400
0.020 mmol/L
Standard Deviation 0.2328
0.241 mmol/L
Standard Deviation 0.1594
0.471 mmol/L
Standard Deviation 0.3418
0.236 mmol/L
Standard Deviation 0.2429
0.163 mmol/L
Standard Deviation 0.1608
—
—
—
—
—
—
PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A
48 Hours
0.111 mmol/L
Standard Deviation 0.4026
-0.275 mmol/L
Standard Deviation 0.3004
0.013 mmol/L
Standard Deviation 0.2093
-0.214 mmol/L
Standard Deviation 0.2378
0.203 mmol/L
Standard Deviation 0.3400
0.419 mmol/L
Standard Deviation 0.3293
0.245 mmol/L
Standard Deviation 0.3457
-0.001 mmol/L
Standard Deviation 0.3891
—
—
—
—
—
—
PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A
96 Hours
-0.109 mmol/L
Standard Deviation 0.4147
-0.358 mmol/L
Standard Deviation 0.4170
-0.061 mmol/L
Standard Deviation 0.1747
-0.481 mmol/L
Standard Deviation 0.3681
-0.018 mmol/L
Standard Deviation 0.3048
-0.020 mmol/L
Standard Deviation 0.6327
0.075 mmol/L
Standard Deviation 0.2565
0.038 mmol/L
Standard Deviation 0.6305
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Predose, Days 7, 14, 21, and 28 Postdose

Population: All randomized participants who received at least one dose of study in Part B.

PD is the change from baseline to last day of dosing in fasting LDL-c in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=8 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
n=8 Participants
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
n=8 Participants
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
n=8 Participants
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B
0.103 mmol/L
Standard Deviation 0.4114
0.184 mmol/L
Standard Deviation 0.3419
0.388 mmol/L
Standard Deviation 0.4876
0.227 mmol/L
Standard Deviation 0.4494
0.131 mmol/L
Standard Deviation 0.4225
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

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

PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=8 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
Placebo
2.906 ng/ml
Geometric Coefficient of Variation 18.72
2.061 ng/ml
Geometric Coefficient of Variation 71.24
—
—
—
—
—
—
—
—
—
—
—
—
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
5 mg LY
2.388 ng/ml
Geometric Coefficient of Variation 58.17
3.374 ng/ml
Geometric Coefficient of Variation 52.99
—
—
—
—
—
—
—
—
—
—
—
—
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
20 mg LY
3.576 ng/ml
Geometric Coefficient of Variation 19.35
3.274 ng/ml
Geometric Coefficient of Variation 26.87
—
—
—
—
—
—
—
—
—
—
—
—
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
100 mg LY
4.634 ng/ml
Geometric Coefficient of Variation 55.59
4.303 ng/ml
Geometric Coefficient of Variation 25.45
—
—
—
—
—
—
—
—
—
—
—
—
PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B
300 mg LY
4.221 ng/ml
Geometric Coefficient of Variation 58.78
1.979 ng/ml
Geometric Coefficient of Variation 55.84
—
—
—
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

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

PK: Area Under Concentration Curve From Zero to Time (AUC \[0-t\]) of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=8 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B
Placebo
9.648 hr*ng/ml
Geometric Coefficient of Variation 38.82
6.250 hr*ng/ml
Geometric Coefficient of Variation 61.54
—
—
—
—
—
—
—
—
—
—
—
—
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B
5 mg LY
6.668 hr*ng/ml
Geometric Coefficient of Variation 42.96
9.287 hr*ng/ml
Geometric Coefficient of Variation 57.54
—
—
—
—
—
—
—
—
—
—
—
—
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B
20 mg LY
9.697 hr*ng/ml
Geometric Coefficient of Variation 26.81
7.960 hr*ng/ml
Geometric Coefficient of Variation 32.21
—
—
—
—
—
—
—
—
—
—
—
—
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B
100 mg LY
14.269 hr*ng/ml
Geometric Coefficient of Variation 53.78
10.434 hr*ng/ml
Geometric Coefficient of Variation 26.20
—
—
—
—
—
—
—
—
—
—
—
—
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B
300 mg LY
11.908 hr*ng/ml
Geometric Coefficient of Variation 60.19
8.951 hr*ng/ml
Geometric Coefficient of Variation 61.65
—
—
—
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

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

PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=8 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B
Placebo
3.479 ng/mL
Geometric Coefficient of Variation 20.58
3.575 ng/mL
Geometric Coefficient of Variation 30.44
—
—
—
—
—
—
—
—
—
—
—
—
PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B
5 mg LY
2.840 ng/mL
Geometric Coefficient of Variation 27.96
3.621 ng/mL
Geometric Coefficient of Variation 82.05
—
—
—
—
—
—
—
—
—
—
—
—
PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B
20 mg LY
1.238 ng/mL
Geometric Coefficient of Variation 38.05
1.286 ng/mL
Geometric Coefficient of Variation 45.27
—
—
—
—
—
—
—
—
—
—
—
—
PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B
100 mg LY
2.511 ng/mL
Geometric Coefficient of Variation 32.17
3.105 ng/mL
Geometric Coefficient of Variation 51.95
—
—
—
—
—
—
—
—
—
—
—
—
PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B
300 mg LY
1.489 ng/mL
Geometric Coefficient of Variation 42.11
1.376 ng/mL
Geometric Coefficient of Variation 59.68
—
—
—
—
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

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

PK: AUC (0-t) of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.

Outcome measures

Outcome measures
Measure
Part A: Placebo
n=8 Participants
Participants were randomly assigned to placebo instead of LY in one of the first three periods.
Part A: 1 mg LY3202328 (LY)
n=8 Participants
1 mg of LY was taken orally in one of four periods.
Part A: 3 mg LY
3 mg of LY was taken orally in one of four periods.
Part A: 10 mg LY
10 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY
30 mg of LY was taken orally in one of four periods.
Part A: 100 mg LY
100 mg of LY was taken orally in one of four periods.
Part A: 300 mg LY
300 mg of LY was taken orally in one of four periods.
Part A: 30 mg LY Fed
30 mg (fed) of LY was taken orally in one of four periods.
Part A: 600 mg LY
600 mg of LY was taken orally in one of four periods.
Part B: SS/AS/Placebo
Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/5 mg of LY
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/20 mg of LY
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/100 mg of LY
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
Part B: SS/AS/300 mg of LY
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29.
PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B
100 mg LY
11.983 hr*ng/ml
Geometric Coefficient of Variation 38.63
13.207 hr*ng/ml
Geometric Coefficient of Variation 61.25
—
—
—
—
—
—
—
—
—
—
—
—
PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B
300 mg LY
7.748 hr*ng/ml
Geometric Coefficient of Variation 50.04
9.111 hr*ng/ml
Geometric Coefficient of Variation 36.39
—
—
—
—
—
—
—
—
—
—
—
—
PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B
Placebo
15.874 hr*ng/ml
Geometric Coefficient of Variation 32.81
16.518 hr*ng/ml
Geometric Coefficient of Variation 33.88
—
—
—
—
—
—
—
—
—
—
—
—
PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B
5 mg LY
17.311 hr*ng/ml
Geometric Coefficient of Variation 6.35
14.913 hr*ng/ml
Geometric Coefficient of Variation 48.97
—
—
—
—
—
—
—
—
—
—
—
—
PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B
20 mg LY
7.921 hr*ng/ml
Geometric Coefficient of Variation 57.94
7.952 hr*ng/ml
Geometric Coefficient of Variation 63.04
—
—
—
—
—
—
—
—
—
—
—
—

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

1 mg LY3202328 (LY)

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

3 mg LY

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

5 mg LY

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

10 mg LY

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

20 mg LY

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

30 mg LY

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

30 mg LY Fed

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

100 mg LY

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

300 mg LY

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

600 mg of LY

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

Serious adverse events

Serious adverse events
Measure
Placebo
n=25 participants at risk
Participants were randomly assigned to placebo instead of LY in one of the first three periods in Part A. Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
1 mg LY3202328 (LY)
n=6 participants at risk
1 mg of LY was taken orally in one of four periods in Part A.
3 mg LY
n=6 participants at risk
3 mg of LY was taken orally in one of four periods in Part A.
5 mg LY
n=8 participants at risk
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
10 mg LY
n=6 participants at risk
10 mg of LY was taken orally in one of four periods in Part A.
20 mg LY
n=8 participants at risk
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
30 mg LY
n=6 participants at risk
30 mg of LY was taken orally in one of four periods in Part A.
30 mg LY Fed
n=4 participants at risk
30 mg of LY (fed) was taken orally in one of four periods in Part A.
100 mg LY
n=12 participants at risk
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
300 mg LY
n=14 participants at risk
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
600 mg of LY
n=5 participants at risk
600 mg of LY was taken orally in one of four periods in Part A.
Investigations
Aspartate aminotransferase increased
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Investigations
Alanine aminotransferase increased
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 2 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.

Other adverse events

Other adverse events
Measure
Placebo
n=25 participants at risk
Participants were randomly assigned to placebo instead of LY in one of the first three periods in Part A. Participants were randomly assigned to multiple ascending doses of placebo instead of LY at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
1 mg LY3202328 (LY)
n=6 participants at risk
1 mg of LY was taken orally in one of four periods in Part A.
3 mg LY
n=6 participants at risk
3 mg of LY was taken orally in one of four periods in Part A.
5 mg LY
n=8 participants at risk
5 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
10 mg LY
n=6 participants at risk
10 mg of LY was taken orally in one of four periods in Part A.
20 mg LY
n=8 participants at risk
20 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
30 mg LY
n=6 participants at risk
30 mg of LY was taken orally in one of four periods in Part A.
30 mg LY Fed
n=4 participants at risk
30 mg of LY (fed) was taken orally in one of four periods in Part A.
100 mg LY
n=12 participants at risk
100 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
300 mg LY
n=14 participants at risk
300 mg of LY was taken orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (SS/AS) one week prior to treatment and on Day 29 in Part B.
600 mg of LY
n=5 participants at risk
600 mg of LY was taken orally in one of four periods in Part A.
Cardiac disorders
Palpitations
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Gastrointestinal disorders
Diarrhea
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Gastrointestinal disorders
Dysphagia
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Gastrointestinal disorders
Epigastric discomfort
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Gastrointestinal disorders
Flatulence
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Gastrointestinal disorders
Nausea
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Gastrointestinal disorders
Stomach pain
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
General disorders
Fatigue
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Infections and infestations
Kidney infection
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Investigations
Alanine aminotransferase increased
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 3 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Investigations
Alt increased
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Investigations
Aspartate aminotransferase increased
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 2 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Investigations
Pr interval prolonged
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
16.7%
1/6 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Metabolism and nutrition disorders
Hypertriglyceridemia
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Musculoskeletal and connective tissue disorders
Pain in hip
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Musculoskeletal and connective tissue disorders
Stiff neck
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Nervous system disorders
Dizziness
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
8.3%
1/12 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Nervous system disorders
Headache
4.0%
1/25 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
25.0%
2/8 • Number of events 2 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
16.7%
1/6 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
25.0%
2/8 • Number of events 2 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
8.3%
1/12 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
14.3%
2/14 • Number of events 2 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Nervous system disorders
Tension headache
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Psychiatric disorders
Anxiety
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Renal and urinary disorders
Dysuria
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Respiratory, thoracic and mediastinal disorders
Dry cough
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
4.0%
1/25 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Skin and subcutaneous tissue disorders
Dermatographic urticaria
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
7.1%
1/14 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Skin and subcutaneous tissue disorders
Papule
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
16.7%
1/6 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
Vascular disorders
Flushed
0.00%
0/25 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
12.5%
1/8 • Number of events 1 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/8 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/6 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/4 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/12 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/14 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.
0.00%
0/5 • From Baseline to End of Study (Up to 10 Weeks)
The safety population are all participants part A and part B combined who received at least one dose of study drug. Several participants received placebo for a second time during the fourth dosing interval, so these participants had 2 placebo-dosing periods.

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