A Phase 2 interventional study of ISIS 681257 and Placebo in Elevated Lipoprotein(a) and Cardiovascular Disease, sponsored by Akcea Therapeutics. Completed at 32 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-30.
Sponsored by Akcea Therapeutics · Phase 2, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of different doses and dosing regimens of ISIS 681257 for reduction of plasma Lipoprotein(a) [Lp(a)] levels in participants with hyperlipoproteinemia(a) and established cardiovascular disease (CVD).
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 286 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Akcea Therapeutics is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Cohort A participants received 20 milligrams (mg) ISIS 681257, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
Drug: ISIS 681257
Cohort B participants received 40 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
Drug: ISIS 681257
Cohort C participants received 60 mg of ISIS 681257, SC injection, once Q4W, for up to 49 weeks and a maximum of 13 doses.
Drug: ISIS 681257
Cohort D participants received 20 mg of ISIS 681257, SC injection, once every 2 weeks (Q2W), for up to 51 weeks and a maximum of 26 doses.
Drug: ISIS 681257
Cohort E participants received 20 mg of ISIS 681257, SC injection, once weekly (QW), for up to 52 weeks and a maximum of 52 doses.
Drug: ISIS 681257
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 681257).
Drug: Placebo
ISIS 681257 solution for SC injection.
Also known as: AKCEA-APO(a)-LRx, IONIS-APO(a)-LRx, TQJ230 and Pelacarsen
Sterile normal saline (0.9% NaCl)
Percent Change From Baseline in Fasting Lipoprotein A [Lp(a)] at the Primary Analysis Time Point
An ANCOVA model was performed on the log ratio of Lp(a) value at the Primary Analysis Time Point to Lp(a) value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Lp(a) value at the Primary Analysis Time Point to Lp(a) value at Baseline - 1) × 100.
Time frame: Baseline and Month 6 (Week 25 for Cohorts A, B and C and Week 27 for Cohorts D and E)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAEs was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study.
Time frame: Up to 16 weeks post treatment period (up to approximately 1.3 years)
Number of Participants With TEAEs by Maximum Severity
An AE was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAEs was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study. The severity of TEAEs was assessed based on the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. TEAEs were graded on a 5-point scale where 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Potentially life-threatening and 5 = Death.
Time frame: Up to 16 weeks post treatment period (up to approximately 1.3 years)
Number of Participants With TEAEs Leading to Study Discontinuation
An AE was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAE was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study.
Time frame: Up to 16 weeks post treatment period (up to approximately 1.3 years)
Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C)
An ANCOVA model was performed on the log ratio of LDL-C value at the Primary Analysis Time Point to LDL-C value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of LDL-C value at the Primary Analysis Time Point to LDL-C value at Baseline - 1) × 100.
Time frame: Baseline and Month 6 (Week 25 for Cohorts A, B and C and Week 27 for Cohorts D and E)
Percentage of Participants Who Achieved Plasma Lp(a) ≤ 125 Nanomoles Per Liter (Nmol/L) or ≤ 50 Milligrams Per Deciliter (mg/dL)
The percentage of participants who achieved ≤ 125 nmol/L or ≤ 50 mg/dL in fasting Lp(a) at the primary analysis time point were compared between each ISIS 681257 treatment group and pooled placebo group using a logistic regression model with log-transformed baseline Lp(a) as a covariate.
Time frame: Baseline and Month 6 (Week 25 for Cohorts A, B and C and Week 27 for Cohorts D and E)
Percentage of Participants Who Achieved Plasma Lp(a) ≤ 75 Nmol/L or ≤ 30 mg/dL
The percentage of participants who achieved ≤ 75 nmol/L or ≤ 30 mg/dL in fasting Lp(a) at the primary analysis time point were compared between each ISIS 681257 treatment group and pooled placebo group using a logistic regression model with log-transformed baseline Lp(a) as a covariate.
Time frame: Baseline and Month 6 (Week 25 for Cohorts A, B and C and Week 27 for Cohorts D and E)
Percent Change From Baseline in the Plasma Levels of Apolipoprotein B (apoB)
An ANCOVA model was performed on the log ratio of apoB value at the Primary Analysis Time Point to apoB value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of apoB value at the Primary Analysis Time Point to apoB value at Baseline - 1) × 100.
Time frame: Baseline and Month 6 (Week 25 for Cohorts A, B and C and Week 27 for Cohorts D and E)
Percent Change From Baseline in the Plasma Levels of Oxidized Phospholipids (OxPL) on Apolipoprotein(a) [OxPL-apo(a)]
An ANCOVA model was performed on the log ratio of OxPL-apo(a) value at the Primary Analysis Time Point to OxPL-apo(a) value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of OxPL-apo(a) value at the Primary Analysis Time Point to OxPL-apo(a) value at Baseline - 1) × 100.
Time frame: Baseline and Month 6 (Week 25 for Cohorts A, B and C and Week 27 for Cohorts D and E)
Percent Change From Baseline in the Plasma Levels of Oxidized Phospholipids (OxPL) on Apolipoprotein B (OxPL-apoB)
An ANCOVA model was performed on the log ratio of OxPL-apoB value at the Primary Analysis Time Point to OxPL-apoB value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of OxPL-apoB value at the Primary Analysis Time Point to OxPL-apoB value at Baseline - 1) × 100.
Time frame: Baseline and Month 6 (Week 25 for Cohorts A, B and C and Week 27 for Cohorts D and E)
To Evaluate Plasma Cmax of ISIS 681257 Across Different Doses and Dose Regimens.
Cmax will be calculated for the treatment groups.
Time frame: 6 months
To Evaluate Plasma Tmax of ISIS 681257 Across Different Doses and Dose Regimens.
Tmax will be calculated for the treatment groups.
Time frame: 6 months
To Evaluate Plasma AUC Values of ISIS 681257 Across Different Doses and Dose Regimens.
AUC values will be calculated for the treatment groups.
Time frame: 6 months
Participants with a clinical diagnosis of hyperlipoproteinemia(a) and established CVD were enrolled in 31 study centers in United States, Canada, Denmark, Germany and Netherlands between 7th March 2017 to 13th November 2018.
| Milestone | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Started | 48 | 48 | 47 | 48 | 48 | 47 |
| Completed | 41 | 47 | 43 | 43 | 36 | 40 |
| Not completed | 7 | 1 | 4 | 5 | 12 | 7 |
| Withdrew: Adverse event | 3 | 0 | 3 | 1 | 6 | 2 |
| Withdrew: Withdrawal by subject | 2 | 1 | 1 | 0 | 4 | 3 |
| Withdrew: Reason not specified | 2 | 0 | 0 | 1 | 2 | 1 |
| Withdrew: Ineligibility | 0 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Investigator judgement | 0 | 0 | 0 | 1 | 0 | 0 |
An ANCOVA model was performed on the log ratio of Lp(a) value at the Primary Analysis Time Point to Lp(a) value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of Lp(a) value at the Primary Analysis Time Point to Lp(a) value at Baseline - 1) × 100.
| percent change | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Percent Change From Baseline in Fasting Lipoprotein A [Lp(a)] at the Primary Analysis Time Point | -35 (-45 to -22) | -56 (-63 to -48) | -72 (-76 to -67) | -58 (-65 to -50) | -80 (-83 to -76) | -6 (-21 to 12) |
An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAEs was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study.
| Participants | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 46 | 43 | 43 | 41 | 44 | 41 |
An AE was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAEs was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study. The severity of TEAEs was assessed based on the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. TEAEs were graded on a 5-point scale where 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Potentially life-threatening and 5 = Death.
| Participants | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Mild | 20 | 21 | 16 | 24 | 21 | 22 |
| Moderate | 20 | 19 | 21 | 15 | 20 | 16 |
| Severe | 6 | 3 | 6 | 2 | 3 | 3 |
An AE was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. TEAE was defined as any AE with onset after the first administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study.
| Participants | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Number of Participants With TEAEs Leading to Study Discontinuation | 3 | 0 | 3 | 1 | 6 | 2 |
An ANCOVA model was performed on the log ratio of LDL-C value at the Primary Analysis Time Point to LDL-C value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of LDL-C value at the Primary Analysis Time Point to LDL-C value at Baseline - 1) × 100.
| percent change | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Percent Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) | -7 (-16 to 3) | -26 (-33 to -18) | -16 (-24 to -7) | -17 (-25 to -8) | -23 (-31 to -14) | -1 (-11 to 9) |
The percentage of participants who achieved ≤ 125 nmol/L or ≤ 50 mg/dL in fasting Lp(a) at the primary analysis time point were compared between each ISIS 681257 treatment group and pooled placebo group using a logistic regression model with log-transformed baseline Lp(a) as a covariate.
| percentage of participants | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Plasma Lp(a) ≤ 125 Nanomoles Per Liter (Nmol/L) or ≤ 50 Milligrams Per Deciliter (mg/dL) | 22.9 | 62.5 | 80.9 | 64.6 | 97.9 | 6.4 |
The percentage of participants who achieved ≤ 75 nmol/L or ≤ 30 mg/dL in fasting Lp(a) at the primary analysis time point were compared between each ISIS 681257 treatment group and pooled placebo group using a logistic regression model with log-transformed baseline Lp(a) as a covariate.
| percentage of participants | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Plasma Lp(a) ≤ 75 Nmol/L or ≤ 30 mg/dL | 6.3 | 25.0 | 53.2 | 33.3 | 70.8 | 0 |
An ANCOVA model was performed on the log ratio of apoB value at the Primary Analysis Time Point to apoB value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of apoB value at the Primary Analysis Time Point to apoB value at Baseline - 1) × 100.
| percent change | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Percent Change From Baseline in the Plasma Levels of Apolipoprotein B (apoB) | -3 (-9 to 4) | -15 (-20 to -10) | -8 (-14 to -2) | -9 (-15 to -3) | -16 (-21 to -10) | 1 (-5 to 8) |
An ANCOVA model was performed on the log ratio of OxPL-apo(a) value at the Primary Analysis Time Point to OxPL-apo(a) value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of OxPL-apo(a) value at the Primary Analysis Time Point to OxPL-apo(a) value at Baseline - 1) × 100.
| percent change | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Percent Change From Baseline in the Plasma Levels of Oxidized Phospholipids (OxPL) on Apolipoprotein(a) [OxPL-apo(a)] | -28 (-41 to -12) | -49 (-58 to -38) | -63 (-70 to -55) | -45 (-55 to -33) | -70 (-75 to -62) | -20 (-35 to -2) |
An ANCOVA model was performed on the log ratio of OxPL-apoB value at the Primary Analysis Time Point to OxPL-apoB value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: = (ratio of OxPL-apoB value at the Primary Analysis Time Point to OxPL-apoB value at Baseline - 1) × 100.
| percent change | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Percent Change From Baseline in the Plasma Levels of Oxidized Phospholipids (OxPL) on Apolipoprotein B (OxPL-apoB) | -37 (-52 to -17) | -57 (-67 to -45) | -79 (-84 to -73) | -64 (-72 to -53) | -88 (-91 to -84) | 14 (-12 to 49) |
Cmax will be calculated for the treatment groups.
Results for this outcome have not been posted.
Tmax will be calculated for the treatment groups.
Results for this outcome have not been posted.
AUC values will be calculated for the treatment groups.
Results for this outcome have not been posted.
Collected over Up to 16 weeks post-treatment period (up to approximately 1.3 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A: ISIS 681257: 20 mg Q4W | 0/48 (0%) | 7/48 (14.6%) | 38/48 (79.2%) |
| Cohort B: ISIS 681257: 40 mg Q4W | 0/48 (0%) | 7/48 (14.6%) | 42/48 (87.5%) |
| Cohort C: ISIS 681257: 60 mg Q4W | 1/47 (2.1%) | 7/47 (14.9%) | 40/47 (85.1%) |
| Cohort D: ISIS 681257: 20 mg Q2W | 0/48 (0%) | 3/48 (6.3%) | 36/48 (75%) |
| Cohort E: ISIS 681257: 20 mg QW | 1/48 (2.1%) | 4/48 (8.3%) | 42/48 (87.5%) |
| Placebo | 0/47 (0%) | 3/47 (6.4%) | 36/47 (76.6%) |
| Event | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Acute myocardial infarctionCardiac disorders | 2/48 | 0/48 | 1/47 | 1/48 | 0/48 | 0/47 |
| Angina unstableCardiac disorders | 1/48 | 0/48 | 1/47 | 1/48 | 0/48 | 0/47 |
| Angina pectorisCardiac disorders | 1/48 | 1/48 | 0/47 | 0/48 | 0/48 | 1/47 |
| Ventricular tachycardiaCardiac disorders | 0/48 | 0/48 | 1/47 | 0/48 | 0/48 | 0/47 |
| Radius fractureInjury, poisoning and procedural complications | 0/48 | 0/48 | 1/47 | 0/48 | 0/48 | 0/47 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/48 | 0/48 | 1/47 | 0/48 | 0/48 | 0/47 |
| Gastrointestinal anastomotic stenosisInjury, poisoning and procedural complications | 0/48 | 0/48 | 0/47 | 0/48 | 0/48 | 1/47 |
| CystGeneral disorders | 0/48 | 0/48 | 0/47 | 0/48 | 0/48 | 1/47 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/48 | 0/48 | 1/47 | 0/48 | 0/48 | 0/47 |
| Ischaemic strokeNervous system disorders | 0/48 | 0/48 | 0/47 | 0/48 | 0/48 | 1/47 |
| Event | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo |
|---|---|---|---|---|---|---|
| Injection site erythemaGeneral disorders | 3/48 | 13/48 | 13/47 | 11/48 | 22/48 | 0/47 |
| Viral upper respiratory tract infectionInfections and infestations | 8/48 | 10/48 | 8/47 | 8/48 | 15/48 | 11/47 |
| Urinary tract infectionInfections and infestations | 7/48 | 7/48 | 10/47 | 6/48 | 9/48 | 3/47 |
| MyalgiaMusculoskeletal and connective tissue disorders | 4/48 | 5/48 | 10/47 | 6/48 | 3/48 | 5/47 |
| FatigueGeneral disorders | 8/48 | 7/48 | 2/47 | 1/48 | 3/48 | 1/47 |
| Angina pectorisCardiac disorders | 8/48 | 3/48 | 2/47 | 1/48 | 2/48 | 1/47 |
| Back painMusculoskeletal and connective tissue disorders | 2/48 | 7/48 | 2/47 | 1/48 | 4/48 | 3/47 |
| HeadacheNervous system disorders | 6/48 | 7/48 | 4/47 | 4/48 | 6/48 | 5/47 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/48 | 3/48 | 3/47 | 2/48 | 6/48 | 5/47 |
| Upper respiratory tract infectionInfections and infestations | 4/48 | 3/48 | 0/47 | 3/48 | 4/48 | 5/47 |
Safety Set included all participants who were randomized and received at least 1 dose of study drug (ISIS 681257 or placebo).
| Age, Continuous(years) | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Mean | 60.0 (38 to 77) | 61.3 (39 to 80) | 62.2 (40 to 79) | 57.9 (30 to 76) | 58.9 (40 to 75) | 59.9 (34 to 76) | 60.0 (30 to 80) |
| Sex: Female, Male(Participants) | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Female | 19 | 12 | 14 | 17 | 20 | 15 | 97 |
| Male | 29 | 36 | 33 | 31 | 28 | 32 | 189 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 0 | 0 | 1 | 1 | 5 |
| Not Hispanic or Latino | 46 | 47 | 47 | 48 | 47 | 46 | 281 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort A: ISIS 681257: 20 mg Q4W | Cohort B: ISIS 681257: 40 mg Q4W | Cohort C: ISIS 681257: 60 mg Q4W | Cohort D: ISIS 681257: 20 mg Q2W | Cohort E: ISIS 681257: 20 mg QW | Placebo | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 0 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 0 | 0 | 1 | 0 | 6 |
| White | 44 | 45 | 47 | 47 | 47 | 46 | 276 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 | 0 | 0 | 2 |
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Akcea Therapeutics