Trial Outcomes & Findings for A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia (NCT NCT05355402)
NCT ID: NCT05355402
Last Updated: 2026-04-23
Results Overview
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the jump to reference (J2R) approach.
COMPLETED
PHASE2
154 participants
Baseline, Month 6
2026-04-23
Participant Flow
Participants took part at 28 clinical sites including 21 sites in the United States (US) and 7 sites in Canada from 01 June 2022 to 17 January 2023.
A total of 154 participants were enrolled in the study. All Participants were randomized in 1:1 ratio in two cohorts to receive either 50 mg, or 80 mg, and each cohort was further randomly assigned in a 3:1 ratio to receive olezarsen or olezarsen-matching placebo.
Participant milestones
| Measure |
Placebo
Participants received olezarsen-matching placebo, as a single subcutaneous (SC) injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
Participants received olezarsen 50 milligrams (mg), as a single 0.5 milliliters (mL) SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
58
|
57
|
|
Overall Study
COMPLETED
|
38
|
51
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
Baseline characteristics by cohort
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 9.52 • n=60 Participants
|
62.3 years
STANDARD_DEVIATION 10.15 • n=56 Participants
|
60.4 years
STANDARD_DEVIATION 10.77 • n=116 Participants
|
61.8 years
STANDARD_DEVIATION 10.24 • n=7 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=60 Participants
|
24 Participants
n=56 Participants
|
17 Participants
n=116 Participants
|
65 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=60 Participants
|
34 Participants
n=56 Participants
|
40 Participants
n=116 Participants
|
89 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=60 Participants
|
3 Participants
n=56 Participants
|
5 Participants
n=116 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=60 Participants
|
54 Participants
n=56 Participants
|
52 Participants
n=116 Participants
|
140 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
|
Fasting Triglycerides (TG)
|
302.1 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 201.91 • n=60 Participants
|
292.1 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 183.01 • n=56 Participants
|
315.1 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 221.63 • n=116 Participants
|
303.2 milligrams/deciliter (mg/dL)
STANDARD_DEVIATION 201.7 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the jump to reference (J2R) approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting TG at Month 6
|
-7.77 Percent Change
Interval -15.34 to -0.21
|
-57.05 Percent Change
Interval -63.19 to -50.92
|
-60.92 Percent Change
Interval -67.11 to -54.73
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting TG at Month 12
|
-5.59 percent change
Interval -13.09 to 1.9
|
-51.67 percent change
Interval -57.74 to -45.6
|
-60.39 percent change
Interval -66.51 to -54.27
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo). Here, the "overall number of participants analyzed" are the number of participants with baseline TG \<500 mg/dL (5.65 mmol/L).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=53 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=50 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Fasting TG <150 mg/dL (1.69 Millimoles Per Liter [mmol/L]) at Month 6 With Baseline TG <500 mg/dL (5.65 mmol/L)
|
11.4 percentage of participants
|
79.2 percentage of participants
|
84.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo). Here, the "overall number of participants analyzed" are the number of participants with baseline triglycerides \<500 mg/dL (5.65 mmol/L).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=53 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=50 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Fasting TG <150 mg/dL (1.69 mmol/L) at Month 12 With Baseline TG <500 mg/dL (5.65 mmol/L)
|
5.7 percentage of participants
|
69.8 percentage of participants
|
82.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Apolipoprotein C-III (ApoC-III) at Month 6
|
-5.47 percent change
Interval -16.46 to 5.51
|
-69.63 percent change
Interval -79.56 to -59.71
|
-78.72 percent change
Interval -87.79 to -69.65
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting ApoC-III at Month 12
|
-12.40 percent change
Interval -24.02 to -0.77
|
-69.09 percent change
Interval -79.42 to -58.76
|
-83.78 percent change
Interval -93.22 to -74.34
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Very Low-density Lipoprotein Cholesterol (VLDL-C) at Month 6
|
-9.74 percent change
Interval -20.65 to 1.17
|
-55.93 percent change
Interval -65.65 to -46.22
|
-59.46 percent change
Interval -68.79 to -50.13
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in VLDL-C at Month 12
|
-14.90 percent change
Interval -23.97 to -5.82
|
-58.00 percent change
Interval -66.11 to -49.88
|
-66.67 percent change
Interval -74.47 to -58.87
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Month 6
|
3.28 percent change
Interval -7.04 to 13.61
|
-22.11 percent change
Interval -31.33 to -12.89
|
-19.79 percent change
Interval -28.72 to -10.85
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Non-HDL-C at Month 12
|
-2.55 percent change
Interval -11.91 to 6.81
|
-20.00 percent change
Interval -28.23 to -11.76
|
-26.57 percent change
Interval -34.59 to -18.55
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting High-density Lipoprotein Cholesterol (HDL-C) at Month 6
|
8.38 percent change
Interval -3.7 to 20.46
|
48.02 percent change
Interval 37.0 to 59.04
|
48.01 percent change
Interval 37.18 to 58.83
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting HDL-C at Month 12
|
10.53 percent change
Interval -1.87 to 22.94
|
54.20 percent change
Interval 42.94 to 65.47
|
57.43 percent change
Interval 46.32 to 68.53
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline Fasting Remnant Cholesterol (Remnant-C) at Month 6
|
-9.46 percent change
Interval -20.39 to 1.47
|
-55.98 percent change
Interval -65.73 to -46.23
|
-59.59 percent change
Interval -68.96 to -50.22
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Remnant-C at Month 12
|
-14.83 percent change
Interval -23.85 to -5.82
|
-58.17 percent change
Interval -66.2 to -50.13
|
-66.90 percent change
Interval -74.63 to -59.17
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Month 6
|
6.82 percent change
Interval -1.44 to 15.07
|
-11.42 percent change
Interval -18.8 to -4.03
|
-11.67 percent change
Interval -18.8 to -4.53
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting ApoB at Month 12
|
0.68 percent change
Interval -7.09 to 8.44
|
-11.67 percent change
Interval -18.45 to -4.9
|
-18.53 percent change
Interval -25.12 to -11.93
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Apolipoprotein A-1 (ApoA-1) at Month 6
|
2.84 percent change
Interval -2.19 to 7.87
|
17.37 percent change
Interval 12.82 to 21.93
|
14.91 percent change
Interval 10.49 to 19.32
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting ApoA-1 at Month 12
|
0.81 percent change
Interval -4.11 to 5.72
|
16.37 percent change
Interval 11.97 to 20.78
|
15.46 percent change
Interval 11.15 to 19.76
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Month 6
|
40.46 percent change
Interval 25.11 to 55.8
|
30.61 percent change
Interval 16.44 to 44.77
|
32.74 percent change
Interval 19.35 to 46.14
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting LDL-C at Month 12
|
35.08 percent change
Interval 21.09 to 49.08
|
32.99 percent change
Interval 20.52 to 45.46
|
27.27 percent change
Interval 15.28 to 39.26
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Total Cholesterol (Total-C) at Month 6
|
2.99 percent change
Interval -4.94 to 10.92
|
-6.78 percent change
Interval -13.86 to 0.3
|
-6.48 percent change
Interval -13.31 to 0.35
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Total-C at Month 12
|
-2.15 percent change
Interval -9.25 to 4.95
|
-6.08 percent change
Interval -12.35 to 0.18
|
-10.80 percent change
Interval -16.87 to -4.72
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo). Here, the "overall number of participants analyzed" is the number of participants with baseline TG ≥500 mg/dL.
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=5 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=7 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Fasting TG <500 mg/dL (5.65 mmol/L) With Baseline TG ≥500 mg/dL at Month 6
|
75.0 percentage of participants
|
80.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo). Here, the "overall number of participants analyzed" is the number of participants with baseline TG ≥500 mg/dL.
Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 12 was defined as the average of Weeks 51 and 53. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the J2R approach.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=5 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=7 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Fasting TG <500 mg/dL (5.65 mmol/L) With Baseline TG ≥500 mg/dL at Month 12
|
75.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
All adverse events (AEs) and serious adverse events (SAEs) that consistently occurred during the study with an event of acute pancreatitis were adjudicated by a blinded, independent committee according to the Atlanta classification of acute pancreatitis as outlined in the Acute Pancreatitis Adjudication Committee (PAC) Charter. These events were categorized as 1) documented pancreatitis, 2) probable pancreatitis, 3) possible pancreatitis, 4) unable to adjudicate and 5) no diagnosis of acute pancreatitis. Number of participants with adjudicated acute pancreatitis events were reported.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Number of Participants With Adjudicated Acute Pancreatitis Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: FAS included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
The adjudicated acute pancreatitis event rates were compared between pooled olezarsen treatment and placebo group using a negative binomial regression model or Poisson regression model with the treatment group and natural log transformed baseline fasting TG as the factors, and number of adjudicated acute pancreatitis events in 5 years prior to enrollment as a covariate. The logarithm of time in year that each participant observed during the treatment period were used as an offset variable. Number of participants with adjudicated acute pancreatitis events with ≥2 events in 5 years prior to enrollment were reported.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 Participants
Participants received olezarsen 50 mg, as a single 0.5 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 80 mg
n=57 Participants
Participants received olezarsen 80 mg, as a single 0.8 mL SC injection, once every 4 weeks for 53 weeks treatment period.
|
|---|---|---|---|
|
Number of Participants With Adjudicated Acute Pancreatitis Events (≥2 Events in 5 Years Prior to Enrollment)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Olezarsen 50 mg
Olezarsen 80 mg
Serious adverse events
| Measure |
Placebo
n=39 participants at risk
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 participants at risk
Participants received olezarsen 50 mg, administered SC as a single 0.5 mL injection, once every 4 weeks, during Weeks 1 to 49 of the treatment period.
|
Olezarsen 80 mg
n=57 participants at risk
Participants received olezarsen 80 mg, administered SC as a single 0.8 mL injection, once every 4 weeks, during Weeks 1 to 49 of the treatment period.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
General disorders
Death
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Sepsis
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Injury, poisoning and procedural complications
Head injury
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
Other adverse events
| Measure |
Placebo
n=39 participants at risk
Participants received olezarsen-matching placebo, as a single SC injection, once every 4 weeks for 53 weeks treatment period.
|
Olezarsen 50 mg
n=58 participants at risk
Participants received olezarsen 50 mg, administered SC as a single 0.5 mL injection, once every 4 weeks, during Weeks 1 to 49 of the treatment period.
|
Olezarsen 80 mg
n=57 participants at risk
Participants received olezarsen 80 mg, administered SC as a single 0.8 mL injection, once every 4 weeks, during Weeks 1 to 49 of the treatment period.
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Sinusitis
|
10.3%
4/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
3.4%
2/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.3%
3/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Acute sinusitis
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.3%
3/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Bronchitis
|
7.7%
3/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.2%
3/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Investigations
Blood creatine phosphokinase increased
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.3%
3/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Investigations
Glomerular filtration rate decreased
|
7.7%
3/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
6.9%
4/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
7.0%
4/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
8.6%
5/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
8.6%
5/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Renal and urinary disorders
Dysuria
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.3%
3/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.7%
1/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
3.4%
2/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Pyelonephritis
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
0.00%
0/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.2%
3/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.3%
3/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Investigations
Liver function test increased
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.2%
3/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
General disorders
Injection site erythema
|
0.00%
0/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
13.8%
8/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
3.5%
2/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
General disorders
Fatigue
|
2.6%
1/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
10.3%
6/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
1.8%
1/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
COVID-19
|
5.1%
2/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
8.6%
5/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
7.0%
4/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
|
Infections and infestations
Urinary tract infection
|
15.4%
6/39 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
10.3%
6/58 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
5.3%
3/57 • Up to 15 months
The safety set included all participants who were randomized and received any amount of study drug (olezarsen or placebo).
|
Additional Information
Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place