At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Subjects With Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic Fatty Liver Disease (NAFLD)
In Brief
A Phase 2 clinical trial evaluating Placebo, ISIS 703802 40 mg, and 2 other interventions for NAFLD and 3 related conditions. Completed, enrolled 105 participants across 42 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
Placebo (Matched with ISIS 703802)
ISIS 703802 40 mg, administered via SC injection, once every 4 weeks for 6 doses.
ISIS 703802 80 mg, administered via SC injection, once every 4 weeks for 6 doses.
ISIS 703802 20 mg, administered via SC injection, once every week for 26 doses.