Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver fat in participants with hypertriglyceridemia, Type 2 diabetes mellitus (T2DM), and nonalcoholic fatty liver disease (NAFLD).
Timeline
- Start
- 2017-12-21
- Primary completion
- 2019-11-21
- Completion
- 2020-02-24
Outcome
Met primary endpoint
registry Pooled Placebo vs Cohort B: ISIS 703802, 40 mg Q4W; p = 0.0343; Mean Difference in % CFB -24 NCT03371355 ↗
registry Pooled Placebo vs Cohort C: ISIS 703802, 80 mg Q4W; p <0.0001; Mean Difference in % CFB -44 NCT03371355 ↗
registry Pooled Placebo vs Cohort A: ISIS 703802, 20 mg QW; p = 0.0009; Mean Difference in % CFB -37 NCT03371355 ↗
release “The study met the primary endpoint of significant triglyceride lowering and multiple secondary endpoints with a favorable safety and tolerability profile.” ionis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vupanorsen | Unknown | 20 mg | Subcutaneous |
| Subject | Vupanorsen | Unknown | 40 mg | Subcutaneous |
| Subject | Vupanorsen | Unknown | 80 mg | Subcutaneous |