Trial Outcomes & Findings for A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD) (NCT NCT06007651)
NCT ID: NCT06007651
Last Updated: 2026-04-13
Results Overview
Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
Baseline up to 36 weeks (Part A)
Results posted on
2026-04-13
Participant Flow
The study was planned to include Part A (single-ascending-dose \[SAD\]) and Part B (multiple-ascending-dose \[MAD\]). However, the study was terminated early and did not proceed to Part B; therefore, no participants were enrolled in Part B
Participant milestones
| Measure |
Part A: SAD Cohort 1
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
Part A: Placebo group
|
Part B: MAD
Participants were planned to receive multiple ascending doses of LY3885125 administered subcutaneously
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
10
|
9
|
10
|
10
|
0
|
|
Overall Study
Dosed
|
6
|
4
|
8
|
9
|
10
|
10
|
0
|
|
Overall Study
COMPLETED
|
6
|
4
|
8
|
9
|
10
|
10
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: SAD Cohort 1
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
Part A: Placebo group
|
Part B: MAD
Participants were planned to receive multiple ascending doses of LY3885125 administered subcutaneously
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
All Participants aged 18 to 70
Baseline characteristics by cohort
| Measure |
Part A: SAD Cohort 1
n=6 Participants
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
n=4 Participants
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously
|
Part A: SAD Cohort 3
n=10 Participants
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
n=9 Participants
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
n=10 Participants
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
n=10 Participants
Part A: Placebo group
|
Part B: MAD
Part B: Participants were planned to receive multiple ascending doses of LY3885125 administered subcutaneously.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
5 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
8 Participants
n=112 Participants
|
6 Participants
n=103 Participants
|
7 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
33 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
7 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
4 Participants
n=103 Participants
|
6 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
27 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
7 Participants
n=112 Participants
|
6 Participants
n=103 Participants
|
4 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants • All Participants aged 18 to 70
|
0 Participants
n=193 Participants • All Participants aged 18 to 70
|
0 Participants
n=386 Participants • All Participants aged 18 to 70
|
0 Participants
n=112 Participants • All Participants aged 18 to 70
|
0 Participants
n=103 Participants • All Participants aged 18 to 70
|
0 Participants
n=539 Participants • All Participants aged 18 to 70
|
0 Participants
n=8 Participants • All Participants aged 18 to 70
|
0 Participants
n=21 Participants • All Participants aged 18 to 70
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=193 Participants • All Participants aged 18 to 70
|
4 Participants
n=193 Participants • All Participants aged 18 to 70
|
10 Participants
n=386 Participants • All Participants aged 18 to 70
|
9 Participants
n=112 Participants • All Participants aged 18 to 70
|
10 Participants
n=103 Participants • All Participants aged 18 to 70
|
10 Participants
n=539 Participants • All Participants aged 18 to 70
|
0 Participants
n=8 Participants • All Participants aged 18 to 70
|
49 Participants
n=21 Participants • All Participants aged 18 to 70
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants • All Participants aged 18 to 70
|
0 Participants
n=193 Participants • All Participants aged 18 to 70
|
0 Participants
n=386 Participants • All Participants aged 18 to 70
|
0 Participants
n=112 Participants • All Participants aged 18 to 70
|
0 Participants
n=103 Participants • All Participants aged 18 to 70
|
0 Participants
n=539 Participants • All Participants aged 18 to 70
|
0 Participants
n=8 Participants • All Participants aged 18 to 70
|
0 Participants
n=21 Participants • All Participants aged 18 to 70
|
|
Sex: Female, Male
Female
|
1 Participants
n=193 Participants
|
3 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
1 Participants
n=112 Participants
|
4 Participants
n=103 Participants
|
3 Participants
n=539 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 36 weeks (Part A)Population: Participants who were dosed were analyzed for adverse events.
Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Outcome measures
| Measure |
Part A: SAD Cohort 1
n=6 Participants
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
n=4 Participants
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
n=8 Participants
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
n=9 Participants
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
n=10 Participants
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
n=10 Participants
Part A: Placebo group
|
|---|---|---|---|---|---|---|
|
Part A: Number of Participants With One or More Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 36 weeks (Part B)Population: The study was terminated early and did not proceed to Part B; therefore, no participants were enrolled, and zero participants were analyzed.
Part B: A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 36 weeks (Part A)Population: AUCinf
Part A: PK: AUC of LY3885125
Outcome measures
| Measure |
Part A: SAD Cohort 1
n=6 Participants
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
n=4 Participants
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
n=8 Participants
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
n=9 Participants
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
n=10 Participants
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
n=10 Participants
Part A: Placebo group
|
|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125
|
255 h*ng/mL
Geometric Coefficient of Variation 0.0496
|
1350 h*ng/mL
Geometric Coefficient of Variation 38.4
|
6960 h*ng/mL
Geometric Coefficient of Variation 21.8
|
19300 h*ng/mL
Geometric Coefficient of Variation 15.8
|
37500 h*ng/mL
Geometric Coefficient of Variation 25.1
|
0 h*ng/mL
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: Baseline up to 36 weeks (Part A)Population: Cmax
Part A: PK: Cmax of LY3885125
Outcome measures
| Measure |
Part A: SAD Cohort 1
n=6 Participants
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
n=4 Participants
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
n=8 Participants
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
n=9 Participants
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
n=10 Participants
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
n=10 Participants
Part A: Placebo group
|
|---|---|---|---|---|---|---|
|
Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125
|
14.8 ng/mL
Geometric Coefficient of Variation 38.8
|
48.5 ng/mL
Geometric Coefficient of Variation 53.4
|
286 ng/mL
Geometric Coefficient of Variation 29.1
|
671 ng/mL
Geometric Coefficient of Variation 40.7
|
1400 ng/mL
Geometric Coefficient of Variation 31.3
|
0 ng/mL
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: Baseline up to 36 weeks (Part A)Population: Tmax
Part A: PK: Tmax of LY3885125
Outcome measures
| Measure |
Part A: SAD Cohort 1
n=6 Participants
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
n=4 Participants
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
n=8 Participants
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
n=9 Participants
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
n=10 Participants
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
n=10 Participants
Part A: Placebo group
|
|---|---|---|---|---|---|---|
|
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125
|
7.5 hours
Interval 3.0 to 9.13
|
9 hours
Interval 1.55 to 9.0
|
6 hours
Interval 3.0 to 9.0
|
9 hours
Interval 6.0 to 12.0
|
9 hours
Interval 6.0 to 12.0
|
0 hours
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 169 (Part A)Population: Change in Baseline to follow up visit day 169
Part A: PD: Change From Baseline in PCSK9
Outcome measures
| Measure |
Part A: SAD Cohort 1
n=6 Participants
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
n=4 Participants
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
n=8 Participants
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
n=9 Participants
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
n=10 Participants
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
n=10 Participants
Part A: Placebo group
|
|---|---|---|---|---|---|---|
|
Part A: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
|
72.2650 ng/mL
Interval 46.49 to 125.86
|
96.430 ng/mL
Interval -3.0 to 196.88
|
19.760 ng/mL
Interval -133.38 to 113.31
|
28.680 ng/mL
Interval -6.42 to 68.69
|
26.995 ng/mL
Interval -12.58 to 79.09
|
57.550 ng/mL
Interval -88.55 to 186.33
|
SECONDARY outcome
Timeframe: Baseline up to Day 169 (Part A)Population: Change from Baseline to Follow up Visit Day 169
Part A: PD: Change From Baseline in ApoB
Outcome measures
| Measure |
Part A: SAD Cohort 1
n=6 Participants
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
n=4 Participants
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
n=8 Participants
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
n=9 Participants
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
n=10 Participants
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
n=10 Participants
Part A: Placebo group
|
|---|---|---|---|---|---|---|
|
Part A: PD: Change From Baseline in Apolipoprotein B (ApoB)
|
-34050 ng/mL
Interval -201080.0 to 146740.0
|
-206110 ng/mL
Interval -287700.0 to -101600.0
|
-256315 ng/mL
Interval -521690.0 to 36550.0
|
17310 ng/mL
Interval -121550.0 to 92620.0
|
-73175 ng/mL
Interval -329280.0 to 76580.0
|
-47440 ng/mL
Interval -287380.0 to 182500.0
|
SECONDARY outcome
Timeframe: Baseline up to 62 weeks (Part B)Population: The study was terminated early and did not proceed to Part B; therefore, no participants were enrolled, and zero participants were analyzed.
Part B Only: PD: Change of Liver Fat Content from Baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
Outcome measures
Outcome data not reported
Adverse Events
Part A: SAD Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: SAD Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: SAD Cohort 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A: SAD Cohort 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: SAD Cohort 5
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: MAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: SAD Cohort 1
n=6 participants at risk
Part A: Participants received a single dose of 1st dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 2
n=4 participants at risk
Part A: Participants received a single dose of 2nd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 3
n=8 participants at risk
Part A: Participants received a single dose of 3rd dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 4
n=9 participants at risk
Part A: Participants received a single dose of 4th dose level of LY3885125 administered subcutaneously.
|
Part A: SAD Cohort 5
n=10 participants at risk
Part A: Participants received a single dose of 5th dose level of LY3885125 administered subcutaneously.
|
Part A: Placebo
n=10 participants at risk
Part A: Participants received a single dose of placebo administered subcutaneously.
|
Part B: MAD
Part B: Participants were planned to receive multiple ascending doses of LY3885125 administered subcutaneously.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
25.0%
1/4 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
12.5%
1/8 • Number of events 2 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
22.2%
2/9 • Number of events 2 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
10.0%
1/10 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
20.0%
2/10 • Number of events 3 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
25.0%
1/4 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
12.5%
1/8 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/9 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
10.0%
1/10 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/4 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
12.5%
1/8 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/9 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
20.0%
2/10 • Number of events 2 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
Investigations
AST Increased
|
16.7%
1/6 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
25.0%
1/4 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/8 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/9 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/4 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
12.5%
1/8 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/9 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
10.0%
1/10 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/4 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
12.5%
1/8 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
11.1%
1/9 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/4 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
12.5%
1/8 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
11.1%
1/9 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
General disorders
Injection Site Pain
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/4 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/8 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
22.2%
2/9 • Number of events 2 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/4 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
12.5%
1/8 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/9 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/10 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
10.0%
1/10 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/4 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/8 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
0.00%
0/9 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
10.0%
1/10 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
10.0%
1/10 • Number of events 1 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
—
0/0 • Baseline up to 36 weeks
Adverse events were collected from the time of informed consent signature through the end of study participation. Treatment-emergent adverse events (TEAEs) were defined as events that emerged or worsened after the first dose of study intervention. Events occurring after the last follow-up visit were included in the analysis only if the investigator believed the event was at least possibly related to study intervention. Participants who were dosed were analyzed for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place