Trial Outcomes & Findings for The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia (NCT NCT02300233)
NCT ID: NCT02300233
Last Updated: 2022-04-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
114 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2022-04-13
Participant Flow
A total of 114 participants were randomized at multiple study centers worldwide.
114 participants were randomized, and 113 received study drug. One patient was randomized, but discontinued before dosing, and thus included only in the volanesorsen Total (Not public) column. The study included a ≤ 8-week screening period (including a diet-stabilization period), a 26-week treatment period, and a 13-week post-treatment evaluation period.
Participant milestones
| Measure |
Placebo
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Weekly
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
25
|
50
|
|
Overall Study
COMPLETED
|
34
|
24
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
23
|
Reasons for withdrawal
| Measure |
Placebo
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Weekly
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event or Serious Adverse Event
|
3
|
1
|
14
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
|
Overall Study
Investigator Judgement
|
0
|
0
|
1
|
|
Overall Study
Reason Not Specified
|
0
|
0
|
5
|
Baseline Characteristics
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Weekly
n=25 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
n=50 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 10 • n=5 Participants
|
50 years
STANDARD_DEVIATION 9 • n=7 Participants
|
51 years
STANDARD_DEVIATION 11 • n=5 Participants
|
51 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Fasting Triglycerides
|
1414 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 1253 • n=5 Participants
|
1046 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 560 • n=7 Participants
|
1251 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 838 • n=5 Participants
|
1261 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 955 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsPopulation: The full analysis set (FAS) included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.
Outcome measures
| Measure |
Placebo
n=38 Participants
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen Total
n=75 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
|
-0.9 percent change
Interval -13.9 to 12.2
|
-71.2 percent change
Interval -79.3 to -63.2
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Volanesorsen 300 mg biweekly group includes patients who received weekly dosing in first 13 weeks, and then bi-weekly for 13 weeks. For month 3 assessments, the results were combined since all patients were on weekly dosing. And for month 6 assessments, the results were split to show the results in each dosing group.
Outcome measures
| Measure |
Placebo
n=38 Participants
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen Total
n=75 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Absolute Change in Fasting TG From Baseline to Month 3
|
74 mg/dL
Interval -138.0 to 285.0
|
-869 mg/dL
Interval -1018.0 to -720.0
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.
Outcome measures
| Measure |
Placebo
n=38 Participants
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen Total
n=75 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3
|
5 Participants
|
65 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.
Outcome measures
| Measure |
Placebo
n=38 Participants
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen Total
n=75 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline
|
4.4 percent change
Interval -5.2 to 14.0
|
61.2 percent change
Interval 54.2 to 68.3
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment.
mg/dL = milligrams per deciliter
Outcome measures
| Measure |
Placebo
n=38 Participants
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen Total
n=75 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3
|
0 Participants
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 and 6 monthsPopulation: The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Number analyzed were the participants evaluated at the given time point.
HOMA-IR was calculated using the following formula: fasting insulin micro-international units per millimeter (μIU/mL) x fasting glucose mg/dL\]/405. A negative change from baseline indicates improvement; a positive change from baseline indicates worsening.
Outcome measures
| Measure |
Placebo
n=38 Participants
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen Total
n=25 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
n=50 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Month 3
|
-0.29 score
Standard Deviation 3.12
|
1.53 score
Standard Deviation 4.89
|
-0.45 score
Standard Deviation 4.97
|
|
Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Month 6
|
-0.37 score
Standard Deviation 3.18
|
1.54 score
Standard Deviation 7.69
|
0.56 score
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: Baseline to 3 and 6 monthsPopulation: The FAS included all participants who were randomized, received at least one dose of study drug, and had a baseline TG assessment. Number analyzed were the T2DM participants evaluated at the given time point.
Outcome measures
| Measure |
Placebo
n=14 Participants
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen Total
n=9 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks; or once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
n=21 Participants
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
Month 3
|
-0.0 percentage
Standard Deviation 0.5
|
0.4 percentage
Standard Deviation 0.6
|
0.1 percentage
Standard Deviation 0.5
|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants
Month 6
|
-0.2 percentage
Standard Deviation 0.6
|
0.8 percentage
Standard Deviation 0.9
|
0.3 percentage
Standard Deviation 0.9
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Volanesorsen 300 mg Weekly
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Volanesorsen 300 mg Biweekly, Post Week 13
Serious events: 6 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=38 participants at risk
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Weekly
n=25 participants at risk
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
n=50 participants at risk
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileus paralytic
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Serum sickness
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pancreas infection
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=38 participants at risk
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Weekly
n=25 participants at risk
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
|
Volanesorsen 300 mg Biweekly, Post Week 13
n=50 participants at risk
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
|
|---|---|---|---|
|
General disorders
Injection site erythema
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
92.0%
23/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
76.0%
38/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
40.0%
10/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
58.0%
29/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site swelling
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
48.0%
12/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
48.0%
24/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
40.0%
10/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
34.0%
17/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site discolouration
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
48.0%
12/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
22.0%
11/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site induration
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
28.0%
7/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
22.0%
11/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site discomfort
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
22.0%
11/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
10.5%
4/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
14.0%
7/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
20.0%
10/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site rash
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
12.0%
3/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
12.0%
6/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
10.0%
5/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
16.0%
4/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
4/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site warmth
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
12.0%
6/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
12.0%
3/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
10.0%
5/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
10.0%
5/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site inflammation
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site mass
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Injection site oedema
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
6.0%
3/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
4/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
20.0%
5/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
10.0%
5/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
18.0%
9/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
12.0%
6/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
4/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.9%
3/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
6.0%
3/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
13.2%
5/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
32.0%
8/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
4/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
7.9%
3/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
6.0%
3/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
4/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
16.0%
4/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
16.0%
8/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
14.0%
7/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
10.0%
5/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
4/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Red blood cell sedimentation rate increased
|
10.5%
4/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
24.0%
6/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
10.0%
5/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
12.0%
3/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
10.0%
5/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
12.0%
3/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
4/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
6.0%
3/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
6.0%
3/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
16.0%
8/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
6.0%
3/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
1/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
10.5%
4/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
10.0%
5/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
12.0%
3/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
6.0%
3/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
3/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
4.0%
2/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.6%
1/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
2.0%
1/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
2/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/38 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
8.0%
2/25 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/50 • Up to approximately 39 weeks.
The safety set included all randomized participants who received at least one dose of study drug.
|
Additional Information
Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc.
Phone: 800-679-4747
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place