Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a) (NCT NCT04987320)
NCT ID: NCT04987320
Last Updated: 2025-02-10
Results Overview
The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Olpasiran Low Dose
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Olpasiran Low Dose
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)
Baseline characteristics by cohort
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 11.23 • n=99 Participants
|
49.4 years
STANDARD_DEVIATION 9.23 • n=107 Participants
|
45.3 years
STANDARD_DEVIATION 10.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85Population: PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.
The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) of Olpasiran
|
144 ng/mL
Geometric Coefficient of Variation 55.5
|
549 ng/mL
Geometric Coefficient of Variation 71.5
|
SECONDARY outcome
Timeframe: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85Population: PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Olpasiran
|
2660 h*ng/mL
Geometric Coefficient of Variation 24.0
|
12000 h*ng/mL
Geometric Coefficient of Variation 41.2
|
SECONDARY outcome
Timeframe: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85Population: PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Olpasiran
|
2660 h*ng/mL
Geometric Coefficient of Variation 24.2
|
12000 h*ng/mL
Geometric Coefficient of Variation 41.3
|
SECONDARY outcome
Timeframe: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85Population: PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Time to Cmax (Tmax) of Olpasiran
|
3.02 hours
Interval 2.85 to 9.0
|
3.11 hours
Interval 2.88 to 12.0
|
SECONDARY outcome
Timeframe: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85Population: PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Apparent Terminal Elimination Half-life (T1/2) of Olpasiran
|
6.05 hours
Standard Deviation 1.59
|
6.69 hours
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85Population: PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran
|
238 liters
Geometric Coefficient of Variation 43.5
|
176 liters
Geometric Coefficient of Variation 60.2
|
SECONDARY outcome
Timeframe: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85Population: PK Analysis Set: included all randomized participants who received olpasiran and had evaluable PK data.
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Apparent Total Body Clearance (CL/F) of Olpasiran
|
28.2 L/h
Geometric Coefficient of Variation 24.0
|
18.8 L/h
Geometric Coefficient of Variation 41.2
|
SECONDARY outcome
Timeframe: Up to Day 225Population: Safety Analysis Set: included all randomized participants who received olpasiran.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as an AE that starts on or after the first dose of investigational product and up to end of study. Clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms, and vital signs were reported as AEs.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 15, 57, 155 and 225Population: Pharmacodynamic (PD) Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=11 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Percentage Change From Baseline in Triglycerides
Day 7
|
21.8 percentage change in triglycerides
Standard Deviation 30.1
|
-10.0 percentage change in triglycerides
Standard Deviation 39.1
|
|
Percentage Change From Baseline in Triglycerides
Day 15
|
10.4 percentage change in triglycerides
Standard Deviation 33.2
|
-12.9 percentage change in triglycerides
Standard Deviation 22.1
|
|
Percentage Change From Baseline in Triglycerides
Day 57
|
7.55 percentage change in triglycerides
Standard Deviation 35.1
|
-2.35 percentage change in triglycerides
Standard Deviation 36.3
|
|
Percentage Change From Baseline in Triglycerides
Day 155
|
-2.87 percentage change in triglycerides
Standard Deviation 32.8
|
-16.2 percentage change in triglycerides
Standard Deviation 25.3
|
|
Percentage Change From Baseline in Triglycerides
Follow-up (Day 225)
|
26.6 percentage change in triglycerides
Standard Deviation 50.7
|
-10.4 percentage change in triglycerides
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 15, 57, 155 and 225Population: PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=11 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Day 7
|
23.5 percentage change in VLDL-C
Standard Deviation 37.7
|
-8.43 percentage change in VLDL-C
Standard Deviation 40.2
|
|
Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Day 15
|
13.5 percentage change in VLDL-C
Standard Deviation 41.8
|
-8.10 percentage change in VLDL-C
Standard Deviation 32.3
|
|
Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Day 57
|
7.94 percentage change in VLDL-C
Standard Deviation 38.3
|
4.55 percentage change in VLDL-C
Standard Deviation 60.4
|
|
Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Day 155
|
-0.165 percentage change in VLDL-C
Standard Deviation 43.1
|
-11.9 percentage change in VLDL-C
Standard Deviation 39.0
|
|
Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Follow-up (Day 225)
|
26.7 percentage change in VLDL-C
Standard Deviation 48.4
|
-7.58 percentage change in VLDL-C
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 15, 57, 155 and 225Population: PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=11 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Day 7
|
-4.17 percentage change in LDL-C
Standard Deviation 13.1
|
1.22 percentage change in LDL-C
Standard Deviation 8.36
|
|
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Day 15
|
-0.843 percentage change in LDL-C
Standard Deviation 14.3
|
3.97 percentage change in LDL-C
Standard Deviation 11.9
|
|
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Day 57
|
0.201 percentage change in LDL-C
Standard Deviation 9.64
|
2.29 percentage change in LDL-C
Standard Deviation 9.73
|
|
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Day 155
|
-5.91 percentage change in LDL-C
Standard Deviation 13.5
|
-3.82 percentage change in LDL-C
Standard Deviation 12.6
|
|
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Follow-up (Day 225)
|
2.01 percentage change in LDL-C
Standard Deviation 17.7
|
-5.55 percentage change in LDL-C
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 15, 57, 155 and 225Population: PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=11 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Day 7
|
3.80 percentage change in HDL-C
Standard Deviation 7.28
|
7.41 percentage change in HDL-C
Standard Deviation 6.57
|
|
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Day 15
|
6.65 percentage change in HDL-C
Standard Deviation 6.18
|
11.0 percentage change in HDL-C
Standard Deviation 5.97
|
|
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Day 57
|
7.17 percentage change in HDL-C
Standard Deviation 10.8
|
1.29 percentage change in HDL-C
Standard Deviation 8.40
|
|
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Day 155
|
21.8 percentage change in HDL-C
Standard Deviation 11.0
|
21.3 percentage change in HDL-C
Standard Deviation 9.82
|
|
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Follow-up (Day 225)
|
13.9 percentage change in HDL-C
Standard Deviation 5.25
|
11.3 percentage change in HDL-C
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 15, 57, 155 and 225Population: PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=11 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Percentage Change From Baseline in Total Cholesterol
Day 7
|
0.923 percentage change in total cholesterol
Standard Deviation 10.2
|
0.956 percentage change in total cholesterol
Standard Deviation 6.78
|
|
Percentage Change From Baseline in Total Cholesterol
Day 15
|
2.45 percentage change in total cholesterol
Standard Deviation 9.52
|
3.70 percentage change in total cholesterol
Standard Deviation 9.03
|
|
Percentage Change From Baseline in Total Cholesterol
Day 57
|
2.17 percentage change in total cholesterol
Standard Deviation 7.41
|
0.879 percentage change in total cholesterol
Standard Deviation 7.20
|
|
Percentage Change From Baseline in Total Cholesterol
Day 155
|
1.20 percentage change in total cholesterol
Standard Deviation 9.71
|
0.689 percentage change in total cholesterol
Standard Deviation 8.03
|
|
Percentage Change From Baseline in Total Cholesterol
Follow-up (Day 225)
|
6.95 percentage change in total cholesterol
Standard Deviation 9.43
|
-1.82 percentage change in total cholesterol
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 15, 57, 155 and 225Population: PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=11 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)
Day 7
|
2.86 percentage change in ApoA1
Standard Deviation 9.63
|
3.75 percentage change in ApoA1
Standard Deviation 9.46
|
|
Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)
Day 15
|
8.10 percentage change in ApoA1
Standard Deviation 5.61
|
7.95 percentage change in ApoA1
Standard Deviation 8.65
|
|
Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)
Day 57
|
0.185 percentage change in ApoA1
Standard Deviation 8.20
|
-0.294 percentage change in ApoA1
Standard Deviation 8.32
|
|
Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)
Day 155
|
11.4 percentage change in ApoA1
Standard Deviation 9.46
|
9.31 percentage change in ApoA1
Standard Deviation 9.47
|
|
Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)
Follow-up (Day 225)
|
18.1 percentage change in ApoA1
Standard Deviation 8.27
|
11.7 percentage change in ApoA1
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Baseline and Days 7, 15, 57, 155 and 225Population: PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=11 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Percentage Change From Baseline in Apolipoprotein B (Apo B)
Day 7
|
0.0576 percentage change in Apo B
Standard Deviation 11.1
|
1.41 percentage change in Apo B
Standard Deviation 7.54
|
|
Percentage Change From Baseline in Apolipoprotein B (Apo B)
Day 15
|
2.65 percentage change in Apo B
Standard Deviation 8.99
|
1.77 percentage change in Apo B
Standard Deviation 9.34
|
|
Percentage Change From Baseline in Apolipoprotein B (Apo B)
Day 57
|
3.66 percentage change in Apo B
Standard Deviation 10.0
|
1.59 percentage change in Apo B
Standard Deviation 8.49
|
|
Percentage Change From Baseline in Apolipoprotein B (Apo B)
Day 155
|
-0.834 percentage change in Apo B
Standard Deviation 12.9
|
-0.958 percentage change in Apo B
Standard Deviation 9.01
|
|
Percentage Change From Baseline in Apolipoprotein B (Apo B)
Follow-up (Day 225)
|
5.64 percentage change in Apo B
Standard Deviation 12.4
|
-1.90 percentage change in Apo B
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Baseline and Days 2, 4, 7, 15, 29, 57, 85, 113, 155, 183 and 225Population: PD Analysis Set: included all randomized participants who received olpasiran and had evaluable PD data.
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Outcome measures
| Measure |
Olpasiran Low Dose
n=12 Participants
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 Participants
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 2
|
0.245 percentage change in Lp(a)
Standard Deviation 8.57
|
-0.295 percentage change in Lp(a)
Standard Deviation 9.84
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 4
|
-4.93 percentage change in Lp(a)
Standard Deviation 11.4
|
-17.6 percentage change in Lp(a)
Standard Deviation 12.6
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 7
|
-32.9 percentage change in Lp(a)
Standard Deviation 13.2
|
-49.8 percentage change in Lp(a)
Standard Deviation 16.3
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 15
|
-77.3 percentage change in Lp(a)
Standard Deviation 8.46
|
-84.2 percentage change in Lp(a)
Standard Deviation 10.7
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 29
|
-91.0 percentage change in Lp(a)
Standard Deviation 4.20
|
-95.2 percentage change in Lp(a)
Standard Deviation 5.50
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 57
|
-94.8 percentage change in Lp(a)
Standard Deviation 3.80
|
-99.2 percentage change in Lp(a)
Standard Deviation 1.65
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 85
|
-91.4 percentage change in Lp(a)
Standard Deviation 9.89
|
-98.9 percentage change in Lp(a)
Standard Deviation 1.84
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 113
|
-87.8 percentage change in Lp(a)
Standard Deviation 11.1
|
-97.7 percentage change in Lp(a)
Standard Deviation 2.84
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 155
|
-75.8 percentage change in Lp(a)
Standard Deviation 17.9
|
-93.7 percentage change in Lp(a)
Standard Deviation 5.13
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Day 183
|
-67.3 percentage change in Lp(a)
Standard Deviation 18.0
|
-89.1 percentage change in Lp(a)
Standard Deviation 8.17
|
|
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Follow-up (Day 225)
|
-55.1 percentage change in Lp(a)
Standard Deviation 18.5
|
-81.5 percentage change in Lp(a)
Standard Deviation 11.8
|
Adverse Events
Olpasiran Low Dose
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Olpasiran High Dose
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olpasiran Low Dose
n=12 participants at risk
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 participants at risk
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
Other adverse events
| Measure |
Olpasiran Low Dose
n=12 participants at risk
Participants were administered a single dose of olpasiran low dose as a subcutaneous injection on Day 1.
|
Olpasiran High Dose
n=12 participants at risk
Participants were administered a single dose of olpasiran high dose as a subcutaneous injection on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
3/12 • Number of events 3 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
General disorders
Injection site bruising
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
General disorders
Injection site erythema
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
16.7%
2/12 • Number of events 2 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
General disorders
Injection site pain
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
General disorders
Injection site swelling
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
General disorders
Pyrexia
|
25.0%
3/12 • Number of events 3 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Infections and infestations
Covid-19
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
25.0%
3/12 • Number of events 3 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Infections and infestations
Periodontitis
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
16.7%
2/12 • Number of events 2 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Nervous system disorders
Tremor
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
2/12 • Number of events 2 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
2/12 • Number of events 2 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12 • Number of events 2 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
8.3%
1/12 • Number of events 1 • Up to 225 days
Safety Analysis Set: included all randomized participants who received olpasiran.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER