Trial Outcomes & Findings for A Study of LY3561774 in Participants With Mixed Dyslipidemia (NCT NCT05256654)
NCT ID: NCT05256654
Last Updated: 2025-03-17
Results Overview
Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
205 participants
Primary outcome timeframe
Baseline, Day 180
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 100 mg
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
30
|
58
|
59
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
57
|
30
|
58
|
59
|
|
Overall Study
COMPLETED
|
57
|
27
|
55
|
54
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
3
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo subcutaneously (SC) on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 100 mg
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
3
|
|
Overall Study
Earthquake at the Turkey site prevented participation in the study
|
0
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Number of participants with non-missing data, used as denominator
Baseline characteristics by cohort
| Measure |
Placebo
n=58 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.50 years
STANDARD_DEVIATION 11.61 • n=58 Participants
|
58.40 years
STANDARD_DEVIATION 10.97 • n=30 Participants
|
56.40 years
STANDARD_DEVIATION 11.97 • n=58 Participants
|
57.30 years
STANDARD_DEVIATION 10.61 • n=59 Participants
|
56.70 years
STANDARD_DEVIATION 11.30 • n=205 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=58 Participants
|
18 Participants
n=30 Participants
|
29 Participants
n=58 Participants
|
29 Participants
n=59 Participants
|
111 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=58 Participants
|
12 Participants
n=30 Participants
|
29 Participants
n=58 Participants
|
30 Participants
n=59 Participants
|
94 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=58 Participants
|
20 Participants
n=30 Participants
|
39 Participants
n=58 Participants
|
44 Participants
n=59 Participants
|
139 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=58 Participants
|
8 Participants
n=30 Participants
|
19 Participants
n=58 Participants
|
15 Participants
n=59 Participants
|
64 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=59 Participants
|
2 Participants
n=205 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
21 Participants
n=58 Participants
|
11 Participants
n=30 Participants
|
14 Participants
n=58 Participants
|
22 Participants
n=59 Participants
|
68 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=58 Participants
|
6 Participants
n=30 Participants
|
10 Participants
n=58 Participants
|
9 Participants
n=59 Participants
|
36 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=58 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=59 Participants
|
1 Participants
n=205 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=58 Participants
|
13 Participants
n=30 Participants
|
34 Participants
n=58 Participants
|
28 Participants
n=59 Participants
|
100 Participants
n=205 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=205 Participants
|
|
Region of Enrollment
Argentina
|
15 Participants
n=58 Participants
|
8 Participants
n=30 Participants
|
21 Participants
n=58 Participants
|
18 Participants
n=59 Participants
|
62 Participants
n=205 Participants
|
|
Region of Enrollment
Canada
|
5 Participants
n=58 Participants
|
4 Participants
n=30 Participants
|
7 Participants
n=58 Participants
|
2 Participants
n=59 Participants
|
18 Participants
n=205 Participants
|
|
Region of Enrollment
Japan
|
7 Participants
n=58 Participants
|
4 Participants
n=30 Participants
|
7 Participants
n=58 Participants
|
7 Participants
n=59 Participants
|
25 Participants
n=205 Participants
|
|
Region of Enrollment
Mexico
|
21 Participants
n=58 Participants
|
12 Participants
n=30 Participants
|
18 Participants
n=58 Participants
|
26 Participants
n=59 Participants
|
77 Participants
n=205 Participants
|
|
Region of Enrollment
Poland
|
3 Participants
n=58 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=58 Participants
|
1 Participants
n=59 Participants
|
5 Participants
n=205 Participants
|
|
Region of Enrollment
Turkey
|
3 Participants
n=58 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=58 Participants
|
3 Participants
n=59 Participants
|
11 Participants
n=205 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=58 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=58 Participants
|
2 Participants
n=59 Participants
|
7 Participants
n=205 Participants
|
|
Baseline Apolipoprotein B (ApoB)
|
111 milligram per deciliter (mg/dL)
n=56 Participants • Number of participants with non-missing data, used as denominator
|
109.50 milligram per deciliter (mg/dL)
n=30 Participants • Number of participants with non-missing data, used as denominator
|
112 milligram per deciliter (mg/dL)
n=58 Participants • Number of participants with non-missing data, used as denominator
|
114 milligram per deciliter (mg/dL)
n=59 Participants • Number of participants with non-missing data, used as denominator
|
111 milligram per deciliter (mg/dL)
n=203 Participants • Number of participants with non-missing data, used as denominator
|
PRIMARY outcome
Timeframe: Baseline, Day 180Population: All randomized participants receiving at least 1 dose of study drug with evaluable apoB values at baseline, and at least 1 post-baseline measurement.
Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180
|
-14.1 Percent change
Standard Error 4.98
|
-24.3 Percent change
Standard Error 3.10
|
-19.0 Percent change
Standard Error 3.35
|
-11.6 Percent change
Standard Error 3.65
|
SECONDARY outcome
Timeframe: Baseline, Day 180Population: All randomized participants receiving at least 1 dose of study drug with evaluable ANGPTL3 values at baseline, and at least 1 post-baseline measurement.
Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180
|
-55.7 Percent change
Standard Error 4.01
|
-70.8 Percent change
Standard Error 1.86
|
-77.3 Percent change
Standard Error 1.46
|
-3.2 Percent change
Standard Error 6.22
|
SECONDARY outcome
Timeframe: Baseline, Day 180Population: All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C direct values at baseline, and at least 1 post-baseline measurement.
Change in LDL-C levels from baseline to the day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180
|
-9.9 Percent change
Standard Error 5.39
|
-24.0 Percent change
Standard Error 3.21
|
-19.7 Percent change
Standard Error 3.42
|
-8.7 Percent change
Standard Error 3.87
|
SECONDARY outcome
Timeframe: Baseline, Day 180Population: All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.
Change in HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180
|
-2.1 Percent change
Standard Error 3.43
|
-12.8 Percent change
Standard Error 2.15
|
-19.4 Percent change
Standard Error 2.00
|
4.3 Percent change
Standard Error 2.59
|
SECONDARY outcome
Timeframe: Baseline, Day 180Population: All randomized participants receiving at least 1 dose of study drug with evaluable Non HDL-C values at baseline, and at least 1 post-baseline measurement.
Change in non-HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180
|
-19.8 Percent change
Standard Error 4.06
|
-33.1 Percent change
Standard Error 2.41
|
-31.5 Percent change
Standard Error 2.47
|
-10.2 Percent change
Standard Error 3.24
|
SECONDARY outcome
Timeframe: Baseline, Day 180Population: All randomized participants receiving at least 1 dose of study drug with evaluable triglycerides values at baseline, and at least 1 post-baseline measurement.
Change in triglycerides levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Triglycerides at Day 180
|
-45.9 Percent change
Standard Error 3.61
|
-57.8 Percent change
Standard Error 1.98
|
-59.7 Percent change
Standard Error 1.90
|
-15.1 Percent change
Standard Error 4.01
|
SECONDARY outcome
Timeframe: Baseline, Day 270Population: All randomized participants receiving at least 1 dose of study drug with evaluable ANGPTL3 values at baseline, and at least 1 post-baseline measurement.
Change in ANGPTL3 levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)
|
-49.0 Percent change
Standard Error 5.28
|
-61.9 Percent change
Standard Error 2.75
|
-69.8 Percent change
Standard Error 2.19
|
-17.0 Percent change
Standard Error 6.00
|
SECONDARY outcome
Timeframe: Baseline, Day 270Population: All randomized participants receiving at least 1 dose of study drug with evaluable non HDL-C values at baseline, and at least 1 post-baseline measurement.
Change in non-HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
|
-13.5 Percent change
Standard Error 4.44
|
-27.6 Percent change
Standard Error 2.56
|
-27.3 Percent change
Standard Error 2.59
|
-9.8 Percent change
Standard Error 3.22
|
SECONDARY outcome
Timeframe: Baseline, Day 270Population: All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.
Change in HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)
|
-1.9 Percent change
Standard Error 3.48
|
-7.3 Percent change
Standard Error 2.24
|
-10.9 Percent change
Standard Error 2.18
|
1.5 Percent change
Standard Error 2.48
|
SECONDARY outcome
Timeframe: Baseline, Day 270Population: All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C values at baseline, and at least 1 post-baseline measurement.
Change in LDL-C levels from baseline to the day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)
|
-7.1 Percent change
Standard Error 5.81
|
-21.0 Percent change
Standard Error 3.39
|
-17.5 Percent change
Standard Error 3.57
|
-12.7 Percent change
Standard Error 3.78
|
SECONDARY outcome
Timeframe: Baseline, Day 270Population: All randomized participants receiving at least 1 dose of study drug with evaluable apoB values at baseline, and at least 1 post-baseline measurement.
Change in apoB levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS mean using MMRM model adjusted for baseline.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Apolipoprotein B (ApoB)
|
-19.2 Percent change
Standard Error 4.61
|
-19.7 Percent change
Standard Error 3.18
|
-19.4 Percent change
Standard Error 3.20
|
-9.5 Percent change
Standard Error 3.57
|
SECONDARY outcome
Timeframe: Baseline, Day 270Population: All randomized participants receiving at least 1 dose of study drug with evaluable triglycerides values at baseline, and at least 1 post-baseline measurement.
Change in triglycerides levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Outcome measures
| Measure |
LY3561774 100 mg
n=30 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 Participants
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=57 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Percent Change From Baseline for Triglycerides
|
-38.3 Percent change
Standard Error 4.80
|
-50.5 Percent change
Standard Error 2.63
|
-52.5 Percent change
Standard Error 2.55
|
-13.9 Percent change
Standard Error 4.63
|
SECONDARY outcome
Timeframe: On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Seady State AUC (0-∞) of LY3561774
Outcome measures
| Measure |
LY3561774 100 mg
n=58 Participants
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=59 Participants
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
Placebo
n=30 Participants
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774
|
25045 nanogram.hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 24
|
61306 nanogram.hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 43
|
—
|
6979 nanogram.hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 35
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
LY3561774 100 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
LY3561774 400 mg
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
LY3561774 800 mg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=57 participants at risk
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 100 mg
n=30 participants at risk
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 participants at risk
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 participants at risk
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.8%
1/57 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/58 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/58 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/58 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.3%
1/30 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/58 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/57 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/58 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/58 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
3.5%
2/57 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/58 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.8%
1/57 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/58 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/58 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/58 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
Other adverse events
| Measure |
Placebo
n=57 participants at risk
Participants received placebo SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 100 mg
n=30 participants at risk
Participants received 100 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 400 mg
n=58 participants at risk
Participants received 400 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
LY3561774 800 mg
n=59 participants at risk
Participants received 800 mg LY3561774 SC on Day 0 and Day 90 (-5 to +10 days). Follow up was continued until Day 360.
|
|---|---|---|---|---|
|
General disorders
Injection site reaction
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.3%
1/30 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
5.2%
3/58 • Number of events 5 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Covid-19
|
7.0%
4/57 • Number of events 4 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
13.3%
4/30 • Number of events 4 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
5.2%
3/58 • Number of events 3 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Gastroenteritis
|
5.3%
3/57 • Number of events 3 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
10.0%
3/30 • Number of events 3 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.4%
2/58 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
6.7%
2/30 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.4%
2/58 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
3/57 • Number of events 3 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.3%
1/30 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
5.2%
3/58 • Number of events 5 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
3/57 • Number of events 3 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.3%
1/30 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/58 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Investigations
Lipase increased
|
5.3%
3/57 • Number of events 3 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/30 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/58 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
0.00%
0/59 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/57 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
6.7%
2/30 • Number of events 3 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/58 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/59 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
|
Vascular disorders
Hypertension
|
3.5%
2/57 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
6.7%
2/30 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
1.7%
1/58 • Number of events 1 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
3.4%
2/59 • Number of events 2 • Baseline up to 360 Days
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60