Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IONIS DGAT2Rx · 1 trial · 1 indication
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...
IONIS DGAT2Rx is an investigational small molecule being developed for hepatic steatosis, a condition of fat accumulation in the liver. It is being studied in adult patients with type 2 diabetes who also have hepatic steatosis. The drug is currently in Phase 2 clinical development and is not approved by the FDA.
IONIS DGAT2Rx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacodynamics of this investigational drug for hepatic steatosis.
IONIS DGAT2Rx is in Phase 2 clinical development. A Phase 2 trial has been completed, which studied the drug in adult patients with type 2 diabetes and hepatic steatosis. The drug is investigational and has not been approved by regulatory authorities.
IONIS DGAT2Rx has one completed Phase 2 clinical trial registered as NCT03334214, titled 'Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes.' The trial enrolled 44 participants with hepatic steatosis across Canada, Hungary, Poland, and the United Kingdom.
Yes, the Phase 2 clinical trial for IONIS DGAT2Rx (NCT03334214) was a randomized, double-blind, placebo-controlled study. It enrolled 44 adult patients with hepatic steatosis and type 2 diabetes. The trial has been completed, and no active trials for this drug are currently listed.