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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03334214 | Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes | PHASE2 | COMPLETED | 44 | — | — | Nov 3, 2017 | Nov 28, 2018 | Jan 27, 2020 | 22 | Canada, Hungary +2 |
Absolute change in liver fat percentage as quantified by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) from baseline to post-treatment MRI.
Absolute change in liver fat percentage as quantified by MRI-PDFF from baseline to post-treatment MRI.
An adverse event (AE) is any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.
AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, June 2010. Grades: mild - the event is easily tolerated by the participant and does not affect the participant's usual daily activities; moderate - the event causes the participant more discomfort and interrupts the participant's usual daily activities; severe - the event is incapacitating and causes considerable interference with the participant's usual daily activities.
| Arm | Type | Description |
|---|---|---|
| IONIS DGAT2Rx | EXPERIMENTAL | Single Dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks |
| Placebo (sterile saline 0.9) | PLACEBO_COMPARATOR | Calculated volume to match active comparator administered subcutaneously once weekly for 13 weeks |
| Name | Type | Description |
|---|---|---|
| IONIS DGAT2Rx | DRUG | Single Dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks |
| Placebo | DRUG | Saline 0.9% |
Inclusion Criteria: * Must have given written informed consent and be able to comply with all study requirements. * Males or females aged 18-75, inclusive, at the time of Informed Consent. * Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal. * Males m...