Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01529424 | Safety, Tolerability, and Pharmacokinetic Study of ISIS ApoC-III Rx in Hypertriglyceridemia | PHASE2 | COMPLETED | 89 | — | — | Feb 1, 2012 | Jan 1, 2014 | Jan 27, 2022 | 7 | United States, Canada |
The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Non-extensive PK/non post-prandial |
| Group 2a | EXPERIMENTAL | Extensive PK |
| Group 2b | EXPERIMENTAL | Post-prandial assessment |
| Group 3 | EXPERIMENTAL | Stable dose of fibrate |
| Group 4 | EXPERIMENTAL | Fredrickson Type 1 dyslipidemia |
| Name | Type | Description |
|---|---|---|
| ISIS apoC-III Rx | DRUG | Dose 1 |
| Placebo | DRUG | Dose 1 |
Inclusion Criteria: * Severe hypertriglyceridemia Exclusion Criteria: * HbA1c \>/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year * Body mass index (BMI) \>40 kg/m2 * History of bariatric surgery or currently on weight loss drugs * Use of oral co...